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1. Evaluation of an ultrasound bladder scanner in supine and standing position

Author: David Pasquier, Florence Le Tinier, F. Crop, Pauline Comte, Xavier Mirabel, Centre de Recherche en Informatique, Signal et Automatique de Lille - UMR 9189 [CRIStAL], Physique médicale, Service de radiothérapie / curiethérapie, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER, Centre de Recherche en Informatique, Signal et Automatique de Lille - UMR 9189 (CRIStAL), Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS), and Université de Lille-UNICANCER
Subjects: Male, Scanner, Supine position, [SDV]Life Sciences [q-bio], Urinary Bladder, Position (vector), Technical Note, Supine Position, Humans, Medicine, BladderScan, Radiology, Nuclear Medicine and imaging, Instrumentation, radiotherapy, Ultrasonography, Reproducibility, Radiation, business.industry, Reproducibility of Results, Repeated measures design, BVI 9400, Repeatability, Standing Position, Bladder volume, Technical Notes, Nuclear medicine, business, Bladder ultrasound, bladder filling, Radiotherapy, Image-Guided
Abstract: Purpose This study examined the performance of a bladder volume measuring device, the BladderScan (BS) BVI9400. The use of the BS offers the possibility of assessing the bladder volume before positioning the patient and performing the daily image‐guided radiotherapy procedure. Patients often cannot lie down before entering the treatment vault. Therefore, the BS was also assessed in a standing position. Methods The repeatability precision was first evaluated, which is the variability of immediate repeated measures of the BS with same operator and subject. This was followed by the reproducibility precision of the BS in which the operator and subjects differ. Finally, the trueness was evaluated in terms of fixed and proportional bias of the results by applying weighted least‐squares fitting. Note that 53 and 85 patient measurements were carried out in supine and standing position, respectively, each consisting of three repeated BS measurements. These were compared with the computed tomography (CT)‐delineated bladder volume. Results Repeatability was dependent on measurement value (heteroscedasticity) with σ repeatability (BS) = ±15 cm3 ± 10%. However, the total agreement between BS and CT was low with the 95% limits of agreement (LOAs) exceeding ±200 cm3 due to poor patient reproducibility and presence of fixed and proportional bias. Only in the best case of male patients in the supine position, three BS measurements, and correction for the fixed and proportional bias, 95% LOAs of [–147, +114] cm3 were obtained between CT and BS. Conclusion The agreement of the BVI9400 BS with CT was found to be too low for radiotherapy applications.
Published: 2021

2. Comprehensive Genome Profiling in Patients With Metastatic Non-Small Cell Lung Cancer: The Precision Medicine Phase II Randomized SAFIR02-Lung Trial

Author: Boyault, Sandrine, Attignon, Valery, Soubeyran, Isabelle, Morel, Alain, Tran-Dien, Alicia, Jacquet, Alexandra, Dall'Olio, Filippo Gustavo, Jimenez, Marta, Soria, Jean-Charles, Besse, Benjamin, Barlesi, Fabrice, Tomasini, Pascale, Karimi, Maryam, Michiels, Stefan, Raimbourg, Judith, Daniel, Catherine, Janicot, Henri, Madroszyk, Anne, Audigier-Valette, Clarisse, Quoix, Elisabeth, Mazieres, Julien, Moro-Sibilot, Denis, Dansin, Eric, Molinier, Olivier, Morel, Hugues, Pichon, Eric, Cortot, Alexis, Otto, Josiane, Chomy, Francois, Souquet, Pierre-Jean, Cloarec, Nicolas, Giroux-Leprieur, Etienne, Bieche, Ivan, Lacroix, Ludovic, Fondation Synergie Lyon Cancer [Lyon], Centre Léon Bérard [Lyon], Institut Bergonié [Bordeaux], UNICANCER, Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes-Angers (CRCI2NA ), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), Prédicteurs moléculaires et nouvelles cibles en oncologie (PMNCO), Institut Gustave Roussy (IGR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Centre d'Investigation Clinique en Biotherapie des cancers (CIC 1428 , CBT 507 ), Institut Gustave Roussy (IGR)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Multidisciplinary Oncology and Therapeutic Innovations Unit, Hôpital Nord [CHU - APHM], Tarbiat Modares University [Tehran], Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Oncostat (U1018 (Équipe 2)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Institut Curie [Paris], Service de Pneumologie [CHU Clermont-Ferrand], Pôle RHEUNNIRS [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse, CHU Strasbourg, Service de pneumologie [Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU de Grenoble-Alpes, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre Hospitalier Le Mans (CH Le Mans), Intergroupe Francophone de Cancérologie Thoracique [Paris] (IFCT), Intergroupe Francophone de Cancérologie thoracique, Centre Hospitalier Régional d'Orléans (CHRO), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Côte d'Azur (UCA), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), Centre Hospitalier Henri Duffaut (Avignon), Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie (BECCOH), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Saclay, and Département de biologie et pathologie médicales [Gustave Roussy]
Subjects: ErbB Receptors, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, [SDV]Life Sciences [q-bio], Antineoplastic Combined Chemotherapy Protocols, Mutation, Humans, Receptor Protein-Tyrosine Kinases, Precision Medicine, B7-H1 Antigen
Abstract: International audience; Purpose: Targeted therapies (TT) and immune checkpoint blockers (ICB) have revolutionized the approach to non-small cell lung cancer (NSCLC) treatment in the era of precision medicine. Their impact as switch maintenance therapy based on molecular characterization is unknown.Patients and Methods: SAFIR02-Lung was an open-label, randomized, phase II trial, involving 33 centers in France. We investigated eight TT (substudy-1) and one ICB (substudy-2), compared with standard-of-care as a maintenance strategy in patients with advanced EGFR, ALK wild-type (wt) NSCLC without progression after first-line chemotherapy, based on high-throughput genome analysis. The primary outcome was progression-free survival (PFS).Results: Among the 175 patients randomized in substudy-1, 116 received TT (selumetinib, vistusertib, capivasertib, AZD4547, AZD8931, vandetanib, olaparib, savolitinib) and 59 standard-of-care. Median PFS was 2.7 months [95% confidence interval (CI), 1.6-2.9] with TT versus 2.7 months (1.6-4.1) with standard-of-care (HR, 0.97; 95% CI, 0.7-1.36; P = 0.87). There were no significant differences in PFS within any molecular subgroup. In substudy-2, 183 patients were randomized, 121 received durvalumab and 62 standard-of-care. Median PFS was 3.0 months (2.3-4.4) with durvalumab versus 3.0 months (2.0-5.1) with standard-of-care (HR, 0.86; 95% CI, 0.62-1.20; P = 0.38). Preplanned subgroup analysis showed an enhanced benefit with durvalumab in patients with PD-L1 tumor proportion score (TPS) >= 1%, (n = 29; HR, 0.29; 95% CI, 0.11-0.75) as compared with PD-L1 < 1% (n = 31; HR, 0.71; 95% CI, 0.31-1.60; P-interaction = 0.036). Conclusions: Molecular profiling can feasibly be implemented to guide treatment choice for the maintenance strategy in EGFR/ALK wt NSCLC; in this study it did not lead to substantial treatment benefits beyond durvalumab for PD-L1 >= 1 patients.
Published: 2022

3. Relevance of Detection of Mechanisms of Resistance to ALK Inhibitors in ALK-Rearranged NSCLC in Routine Practice

Author: Marie Christine Copin, Philippe Jamme, Radj Gervais, Valérie Grégoire, Nathalie Rabbe, Nicolas Richard, Simon Baldacci, Alexis B. Cortot, Fabienne Escande, Maeva Kyheng, Marie Wislez, Eric Dansin, Zoulika Kherrouche, C. Descarpentries, Mécanismes de tumorigenèse et thérapies ciblées, Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Université de Lille-Centre National de la Recherche Scientifique (CNRS), Pôle de Biologie Pathologie Génétique [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Génétique [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Biologie, génétique et thérapies ostéoarticulaires et respiratoires (BIOTARGEN), Normandie Université (NU)-Normandie Université (NU), Mécanismes de la Tumorigénèse et Thérapies Ciblées - UMR 8161 (M3T), Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre National de la Recherche Scientifique (CNRS), Service de Pneumologie - Oncologie Thoracique - Maladies Pulmonaires Rares [CHU Tenon], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Université de Lille-UNICANCER, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), and Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
Subjects: 0301 basic medicine, Oncology, Male, Cancer Research, Lung Neoplasms, Resistance, Disease, Routine practice, medicine.disease_cause, Anaplastic lymphoma kinase, 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, Medicine, Gene Rearrangement, Real-world evidence, Mutation, Middle Aged, 3. Good health, 030220 oncology & carcinogenesis, Female, Tyrosine kinase, Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, Adolescent, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Young Adult, Crizotinib, Internal medicine, Humans, Clinical significance, In patient, Lung cancer, Protein Kinase Inhibitors, Aged, Neoplasm Staging, Retrospective Studies, business.industry, medicine.disease, Lung neoplasm, respiratory tract diseases, 030104 developmental biology, Drug Resistance, Neoplasm, business
Abstract: Background Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) have shown efficacy in the treatment of ALK-rearranged non–small-cell lung cancer (NSCLC), but the disease eventually progresses in all patients. In many cases, resistance to ALK TKIs arises through ALK mutations. Although clinical and biological data suggest variations in TKI efficacy according to the mechanism of resistance, ALK mutations are still rarely investigated in routine practice. Materials and Methods We performed a retrospective multicentric study with an aim to determine the frequency and clinical relevance of ALK alterations detected using targeted next-generation sequencing in patients with advanced ALK-rearranged NSCLC after progression during an ALK TKI treatment. Data on clinical, pathological, and molecular characteristics and patient outcomes were collected. Results We identified 23 patients with advanced ALK-rearranged NSCLC who, between January 2012 and May 2017, had undergone at least 1 repeat biopsy at progression during an ALK TKI treatment. A resistance mechanism was identified in 9 of the 23 patients (39%). The anomalies involved included 9 ALK mutations in 8 patients and one ALK amplification. The ALK mutation rate was 15% after failure of a first ALK TKI and 33% after failure of 2 ALK TKI treatments. Five of 7 patients who received a different ALK TKI after detection of an ALK mutation achieved an objective response. All of the patients who received a TKI presumed to act on the detected ALK mutant achieved disease control. Conclusion Targeted next-generation sequencing is suitable for detecting ALK resistance mutations in ALK-rearranged NSCLC patients in routine practice. It might help select the best treatment at the time of disease progression during treatment with an ALK TKI.
Published: 2019

4. Nationwide Study of Continuous Deep Sedation Practices Among Pediatric Palliative Care Teams

Author: Ashley Ridley, Elodie Vial-Cholley, Guillaume Robert, Florence Jounis-Jahan, Cyril Lervat, Pierre Betremieux, Marcel-Louis Viallard, Sandra Frache, Nadine Cojean, CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Rennes (UR), CHU Pontchaillou [Rennes], Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Strasbourg, and This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Subjects: Benzodiazepines, Anesthesiology and Pain Medicine, Decision Making, Palliative Care, Continuous Deep Sedation, Neurology (clinical), Pediatrics, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, General Nursing
Abstract: International audience; CONTEXT: Palliative sedation practices evolved in France when the Claeys-Leonetti law passed in 2016 authorized patient-requested continuous deep sedation (CDS) until death. Its implementation in the pediatric setting is less frequently encountered and can pose several clinical and ethical challenges for healthcare teams and families. OBJECTIVES: Our study aimed to describe CDS requests and practices of patients receiving specialized pediatric palliative care in France since its legalization in 2016. METHODS: We conducted a nationwide multicentric, descriptive, retrospective study using a self-report questionnaire completed by all Pediatric Palliative Care (PPC) Teams that were involved in a CDS case between January 2017 and December 2019. RESULTS: Six PPC teams had cared for six patients that had requested CDS, predominantly male adolescents/young adults diagnosed with a solid tumour. The refractory symptoms were diverse (pain, bleeding, sensory loss) and always coupled with psycho-existential suffering. Each request was analyzed in multidisciplinary collegial meetings. Parental consent was always obtained regardless of age. Sedation typically required the use of multiple drugs including Midazolam (n=5 cases), Chlorpromazine (n=3), Ketamine (n=2) and Propofol (n=2). Despite close monitoring, achieving a satisfactory level of deep sedation was challenging and most patients unexpectedly awoke during CDS. Death occurred between 27 and 96 hours after induction. CONCLUSION: Managing patient-requested CDS in pediatrics is challenging due to its rarity, multi-factorial refractory symptoms and drug tolerance despite polytherapy. Few recommendations exist to guide CDS practice for pediatricians. Further studies investigating pediatric CDS practices across various cultural and legal settings, refractory symptom management and specific pharmacology are warranted.
Published: 2023

5. Target volume delineation for radiotherapy of meningiomas: an ANOCEF consensus guideline

Author: Martz, Nicolas, Salleron, Julia, Dhermain, Frédéric, Vogin, Guillaume, Daisne, Jean-François, Mouttet-Audouard, Raphaelle, Tanguy, Ronan, Noel, Georges, Peyre, Matthieu, Lecouillard, Isabelle, Jacob, Julian, Attal, Justine, Charissoux, Marie, Veresezan, Ovidiu, Hanzen, Chantal, Huchet, Aymeri, Latorzeff, Igor, Coutte, Alexandre, Doyen, Jérôme, Stefan, Dinu, Feuvret, Loic, Garcia, Gabriel, Royer, Philippe, Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, Institut Gustave Roussy (IGR), Luxembourg Institute of Health (LIH), Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre Léon Bérard [Lyon], CRLCC Paul Strauss, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), CRLCC Eugène Marquis (CRLCC), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Claudius Regaud, UNICANCER - Institut régional du Cancer Montpellier Val d'Aurelle (ICM), CRLCC Val d'Aurelle - Paul Lamarque, Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), CHU Bordeaux [Bordeaux], Clinique Pasteur [Toulouse], CHU Amiens-Picardie, CHirurgie, IMagerie et REgénération tissulaire de l’extrémité céphalique - Caractérisation morphologique et fonctionnelle - UR UPJV 7516 (CHIMERE), Université de Picardie Jules Verne (UPJV), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Université Côte d'Azur (UCA), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), and Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)
Subjects: Radiotherapy, [SDV.CAN]Life Sciences [q-bio]/Cancer, Delineation, Target volume, Meningiomas, Consensus guidelines
Abstract: International audience; Purpose Radiotherapy is, with surgery, one of the main therapeutic treatment strategies for meningiomas. No prospective study has defined a consensus for the delineation of target volumes for meningioma radiotherapy. Therefore, target volume definition is mainly based on information from retrospective studies that include heterogeneous patient populations. The aim is to describe delineation guidelines for meningioma radiotherapy as an adjuvant or definitive treatment with intensity-modulated radiation therapy and stereotactic radiation therapy techniques. This guideline is based on a consensus endorsed by a multidisciplinary group of brain tumor experts, members of the Association of French-speaking Neuro-oncologists (ANOCEF). Materials and methods A 3-step procedure was used. First, the steering group carried out a comprehensive review to identify divergent issues on meningiomas target volume delineation. Second, an 84-item web-questionnaire has been developed to precisely define meningioma target volume delineation in the most common clinical situations. Third, experts members of the ANOCEF were requested to answer. The first two rounds were completed online. A third round was carried out by videoconference to allow experts to debate and discuss the remaining uncertain questions. All questions remained in a consensus. Results Limits of the target volume were defined using visible landmarks on computed tomography and magnetic resonance imaging, considering the pathways of tumor extension. The purpose was to develop clear and precise recommendations on meningiomas target volumes. Conclusion New recommendations for meningiomas delineation based on simple anatomic boundaries are proposed by the ANOCEF. Improvement in uniformity in target volume definition is expected.
Published: 2023

6. Panitumumab in combination with chemoradiotherapy for the treatment of locally-advanced anal canal carcinoma: Results of the FFCD 0904 phase II trial

Author: Vendrely, Véronique, Ronchin, Philippe, Minsat, Mathieu, Le Malicot, Karine, Lemanski, Claire, Mirabel, Xavier, Etienne, Pierre-Luc, Lièvre, Astrid, Darut-Jouve, Ariane, de la Fouchardière, Christelle, Giraud, Nicolas, Breysacher, Gilles, Argo-Leignel, Delphine, Thimonnier, Elsa, Magné, Nicolas, Abdelghani, Meher Ben, Lepage, Côme, Aparicio, Thomas, BoRdeaux Institute in onCology (Inserm U1312 - BRIC), Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM), Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Agro Dijon, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), Institut du Cancer de Montpellier (ICM), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Oncogenesis, Stress, Signaling (OSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Cancérologie de Bourgogne, Centre Léon Bérard [Lyon], Institut de Cancérologie Lucien Neuwirth, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), CRLCC Paul Strauss, CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hopital Saint-Louis [AP-HP] (AP-HP), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)
Subjects: Epidermal growth factor receptor, Panitumumab, Squamous cell carcinoma, [SDV.CAN]Life Sciences [q-bio]/Cancer, Chemoradiotherapy, Immunotherapy, Anal cancer
Abstract: Background and purpose: Standard treatment of squamous cell carcinoma of the anus (SCCA)is 5-fluorouracil (5FU) and mitomycin C (MMC) based chemoradiotherapy (CRT). This phase II study (EudraCT: 2011-005436-26) assessed the tolerance and complete response (CR) rate at 8 weeks of panitumumab (Pmab) combined with MMC-5FU-based CRT.Methods: Patients with locally advanced tumors without metastases (T2 > 3 cm, T3-T4, or N + whatever T stage) were treated with IMRT up to 65 Gy and concomitant CT according to the doses defined by a previous phase I study (MMC: 10 mg/m2; 5FU: 400 mg/m2; Pmab: 3 mg/kg). The expected CR rate was 80%.Results: Forty-five patients (male: 9, female: 36; median age: 60.1 [41.5-81]) were enrolled in 15 French centers. The most common related grade 3-4 toxicities observed were digestive (51.1%), hematologic (lymphopenia: 73.4%; neutropenia: 11.1%), radiation dermatitis (13.3%), and asthenia (11.1%) with RT interruption in 14 patients. One patient died because of mesenteric ischemia during the CRT, possibly related to treatment. In ITT analysis, the CR rate at 8 weeks after CRT was 66.7% [90%CI: 53.4-78.2]. Median follow-up was 43.6 months [IC 95%: 38.61-47.01]. Overall survival, recurrence-free and colostomy-free survival at 3 years were 80% [95%CI: 65.1-89], 62.2% [IC95%: 46.5-74.6] and 68.8 % [IC95%: 53.1-80.2] respectively.Conclusion: Panitumumab in combination with CRT for locally advanced SCCA failed to meet the expected CR rate and exhibited a poor tolerance. Furthermore, late RFS, CFS, and OS did not suggest any outcome improvement to justify further clinical trials.Clinicaltrials: gov identifier: NCT01581840.
Published: 2023

7. Evaluation of non-supervised MALDI mass spectrometry imaging combined with microproteomics for glioma grade III classification

Author: Isabelle Fournier, Marie Duhamel, Fabienne Escande, Maxence Wisztorski, Firas Kobeissy, Fahed Zairi, Jean-Pascal Gimeno, Claude-Alain Maurage, Nicolas Reyns, Michel Salzet, Emilie Le Rhun, Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U 1192 (PRISM), Université de Lille-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), American University of Beirut [Beyrouth] (AUB), University of Florida [Gainesville] (UF), SALZET, Michel, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université de Lille-UNICANCER, and Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
Subjects: Adult, Male, Proteomics, 0301 basic medicine, MALDI imaging, Proteome, Biopsy, Neurogenesis, [SDV]Life Sciences [q-bio], Biophysics, Microproteomics, Computational biology, Bioinformatics, Biochemistry, Anaplastic glioma, Mass spectrometry imaging, Analytical Chemistry, Young Adult, 03 medical and health sciences, Molecular classification, Neoplasms, Glioma, medicine, Humans, Molecular Biology, Aged, Neoplasm Staging, Inflammation, WHO classification, Matrix-assisted laser desorption/ionization mass spectrometry imaging, Enzymatic digestion, Brain Neoplasms, Chemistry, Proteins, Middle Aged, medicine.disease, 3. Good health, [SDV] Life Sciences [q-bio], Label-free quantification, 030104 developmental biology, Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization, Female, Trypsin Digestion, Peptides
Abstract: International audience; An integrated diagnosis using molecular features is recommended in the 2016 World Health Organization (WHO) classification. Our aim was to explore non-targeted molecular classification using MALDI mass spectrometry imaging (MALDI MSI) associated to microproteomics in order to classify anaplastic glioma by integration of clinical data. We used fresh-frozen tissue sections to perform MALDI MSI of proteins based on their digestion peptides after in-situ trypsin digestion of the tissue sections and matrix deposition by micro-spraying. The generated 70μm spatial resolution image datasets were further processed by individual or global segmentation in order to cluster the tissues according to their molecular protein signature. The clustering gives 3 main distinct groups. Within the tissues the ROIs (regions of interest) defined by these groups were used for microproteomics by micro-extraction of the tryptic peptides after on-tissue enzymatic digestion. More than 2500 proteins including 22 alternative proteins (AltProt) are identified by the Shotgun microproteomics. Statistical analysis on the basis of the label free quantification of the proteins shows a similar classification to the MALDI MSI segmentation into 3 groups. Functional analysis performed on each group reveals sub-networks related to neoplasia for group 1, glioma with inflammation for group 2 and neurogenesis for group 3. This demonstrates the interest on these new non-targeted large molecular data combining both MALDI MSI and microproteomics data, for tumor classification. This analysis provides new insights into grade III glioma organization. This specific information could allow a more accurate classification of the biopsies according to the prognosis and the identification of potential new targeted therapeutic options. This article is part of a Special Issue entitled: MALDI Imaging, edited by Dr. Corinna Henkel and Prof. Peter Hoffmann.
Published: 2017

8. Regosarc: regorafenib versus placebo in doxorubicin-refractory soft-tissue sarcoma-a quality-adjusted time without symptoms of progression or toxicity analysis

Author: Berry, V. (Vincent), Basson, L. (Laurent), Bogart, E. (Emilie), Mir, O. (Olivier), Blay, J-Y. (Jean-Yves), Italiano, A. (Antoine), Bertucci, F. (François), Chevreau, C. (Christine), Clisant-Delaine, S. (Stephanie), Liegl-Atzwanger, B. (Bernadette), Tresch-Bruneel, E. (Emmanuelle), Wallet, J. (Jennifer), Taieb, S. (Sophie), Decoupigny, E. (Emilie), Le Cesne, A. (Axel), Brodowicz, T. (Thomas), Penel, N. (Nicolas), Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Institut Gustave Roussy (IGR), Centre Léon Bérard [Lyon], Institut Bergonié [Bordeaux], UNICANCER, Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Institut Claudius Regaud, Karl-Franzens-Universität Graz, University of Vienna [Vienna], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Lille Nord de France (COMUE)-UNICANCER, Karl-Franzens-Universität [Graz, Autriche], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille, CHU Lille, Université de Lille, Site de Recherche Intégrée en Cancérologie [SIRIC-ONCOLille], METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694, Institut Gustave Roussy [IGR], and Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS]
Subjects: [SDV]Life Sciences [q-bio], Mesh:Diarrhea/chemically induced, Mesh:Alopecia/chemically induced, Mesh:Phenylurea Compounds/therapeutic use, Mesh:Aged, Mesh:Synovial/drug therapy, Mesh:Treatment Outcome, Mesh:Anorexia/chemically induced, Mesh:Quality of Life, Mesh:Proportional Hazards Models, Mesh:Severity of Illness Index, Mesh:Female, quality-adjusted survival, Mesh:Fecal Incontinence/chemically induced, Mesh:Male, Mesh:Sarcoma, Mesh:Middle Aged, quality-adjusted time without symptoms of progression or toxicity (Q-TWiST), Mesh:Asthenia/chemically induced, Mesh:Liposarcoma/drug therapy, metastatic soft-tissue sarcoma, placebo, regorafenib, Mesh:Mucositis/chemically induced, Mesh:Hospitalization, Mesh:Sarcoma/drug therapy, Mesh:Hand-Foot Syndrome/etiology, Mesh:Pyridines/therapeutic use, Mesh:Antineoplastic Agents/therapeutic use, Mesh:Leiomyosarcoma/drug therapy, Mesh:Humans, Mesh:Hypertension/chemically induced, Mesh:Double-Blind Method
Abstract: International audience; BACKGROUND: In a placebo-controlled, randomized phase 2 trial (ClinicalTrials.gov identifier NCT01900743), regorafenib improved progression-free survival (PFS) for patients with doxorubicin-pretreated advanced nonadipocytic sarcoma. A quality-adjusted time without symptoms of progression or toxicity (Q-TWiST) post hoc exploratory analysis was applied to provide an integrated measure of its clinical benefit.METHODS: In the base-case analysis, each patient's overall survival (OS) was partitioned into 3 mutually exclusive health states: the time with a grade 3 or 4 adverse event (TOX), the time without symptoms of disease or grade 3 or 4 toxicity from treatment, and the time after tumor progression or relapse. The time spent in each state was weighted with a health-state utility associated with that state and was summed to calculate the Q-TWiST. The stability of the base-case analysis was explored with several sensitivity analyses.RESULTS: In nonadipocytic sarcoma, the PFS was (4.0 months [2.6-5.5 months] with regorafenib vs 1.0 month [0.9-1.8 months] with a placebo; hazard ratio, 0.36 [0.25-0.53]; P < .0001); the OS was 13.4 months (8.6-17.3 months) with regorafenib and 9.0 months (6.8-12.5 months) with a placebo (hazard ratio, 0.67 [0.44-1.02]). With the classic definition of TOX (including all grade 3 and 4 clinical adverse events), the Q-TWiSTs were 8.0 months (7.0-9.0 months) with regorafenib and 5.7 months (4.9-6.4 months) with a placebo (P
Published: 2017

9. Outcome of EGFR-mutated NSCLC patients with MET-driven resistance to EGFR tyrosine kinase inhibitors

Author: Pascal Do, Marie Wislez, David Tulasne, Nicolas Girard, Pascale Tomasini, Zoulika Kherrouche, Maurice Pérol, Isabelle Monnet, Alexis B. Cortot, Florian Guisier, Denis Moro-Sibilot, Charlotte Leduc, Simon Baldacci, Julien Labreuche, Eric Dansin, Julien Mazieres, Clarisse Audigier-Valette, Etienne Giroux Leprieur, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Mécanismes de la Tumorigénèse et Thérapies Ciblées - UMR 8161 (M3T), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre National de la Recherche Scientifique (CNRS), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, CHU Toulouse [Toulouse], Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Aix Marseille Université (AMU), Hôpital Louis Pradel [CHU - HCL], Hospices Civils de Lyon (HCL), CHU Rouen, Normandie Université (NU), Centre Hospitalier Intercommunal Toulon-La Seyne sur Mer - Hôpital Sainte-Musse, Centre Hospitalier Intercommunal de Créteil (CHIC), CHU Tenon [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Léon Bérard [Lyon], Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Strasbourg, Hôpital Ambroise Paré [AP-HP], Groupe de Recherche Sur Le Cancer du Poumon : Bases Moléculaires de la Progression Tumorale, Dépistage et Thérapie Génique, Institut Albert Bonniot-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Grenoble, Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille, This work was supported by grants from the SIRIC ONCOlille, the Fondation du Souffle, and the Fonds de Dotation Recherche en Santé Respiratoire, The authors are grateful to Ms Maeva Kyheng of the biostatistics unit of Lille University Hospital for her assistance regarding the statistical analysis, and Mr Eric Wasielewski for his support regarding the administrative procedure of the protocol approval., Université de Lille, LillOA, Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Université de Lille-UNICANCER, Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), CHU Lille, CNRS, Université de Lille, Centre Hospitalier Régional Universitaire [Lille] [CHRU Lille], Mécanismes de la Tumorigénèse et Thérapies Ciblées (M3T) - UMR 8161, Université Toulouse III - Paul Sabatier [UT3], Centre de Recherche en Cancérologie de Marseille [CRCM], Aix Marseille Université [AMU], Centre Hospitalier Intercommunal de Créteil [CHIC], Centre Régional de Lutte contre le Cancer François Baclesse [Caen] [UNICANCER/CRLC], Mécanismes de la Tumorigénèse et Thérapies Ciblées - UMR 8161 [M3T], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS], Site de Recherche Intégrée en Cancérologie [SIRIC-ONCOLille], and Université de Toulouse (UT)
Subjects: 0301 basic medicine, Oncology, medicine.medical_specialty, EGFR, Met amplification, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, resistance, 03 medical and health sciences, T790M, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, tyrosine kinase inhibitors, MET, non small cell lung cancer, Internal medicine, Thoracic Oncology, medicine, Lung cancer, Objective response, business.industry, Cancer, University hospital, medicine.disease, EGFR Tyrosine Kinase Inhibitors, 3. Good health, respiratory tract diseases, 030104 developmental biology, 030220 oncology & carcinogenesis, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, [SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, business, Research Paper
Abstract: // Simon Baldacci 1, 15 , Julien Mazieres 2 , Pascale Tomasini 3 , Nicolas Girard 4 , Florian Guisier 5 , Clarisse Audigier-Valette 6 , Isabelle Monnet 7 , Marie Wislez 8 , Maurice Perol 9 , Pascal Do 10 , Eric Dansin 11 , Charlotte Leduc 12 , Etienne Giroux Leprieur 13 , Denis Moro-Sibilot 14 , David Tulasne 15 , Zoulika Kherrouche 1, 15 , Julien Labreuche 16 and Alexis B. Cortot 1, 15 1 CHU Lille, Thoracic Oncology Department, Univ. Lille, Siric ONCOLille, Lille, France 2 Toulouse University Hospital, Universite Paul Sabatier, Toulouse, France 3 Aix-Marseille University, Assistance Publique Hopitaux de Marseille, Multidisciplinary Oncology & Therapeutic Innovations Department, Marseille, France 4 Louis Pradel Hospital, Hospices Civils de Lyon, Lyon, France 5 Rouen University Hospital, Thoracic oncology unit & Normandy University, IRIB, LITIS Lab, EA 4103 QuantIF team, Rouen, France 6 Service de Pneumologie, Centre Hospitalier Sainte Musse, Toulon, France 7 Centre Hospitalier Intercommunal de Creteil, Creteil, France 8 APHP Hopital Tenon, Paris, France 9 Department of Medical Oncology, Centre Leon Berard, Lyon, France 10 Centre Regional de Lutte Contre le Cancer Francois Baclesse, Caen, France 11 Centre Oscar Lambret, Lille, France 12 CHU Strasbourg, Strasbourg, France 13 APHP – Hopital Ambroise Pare, Boulogne-Billancourt, France 14 Unite d’Oncologie Thoracique, Service de Pneumologie, CHU Grenoble-Alpes, La Tronche, France 15 Univ. Lille, CNRS, Institut Pasteur de Lille, UMR 8161, M3T, Mechanisms of Tumorigenesis and Targeted Therapies, Lille, France 16 EA 2694 University of Lille, Lille, France Correspondence to: Alexis B. Cortot, email: alexis.cortot@chru-lille.fr Keywords: non small cell lung cancer; EGFR; tyrosine kinase inhibitors; resistance; MET Received: February 21, 2017 Accepted: August 04, 2017 Published: October 09, 2017 ABSTRACT Background: Several mechanisms of acquired resistance to EGFR tyrosine kinase inhibitors (TKIs) in EGFR-mutated NSCLC have been described including the T790M mutation and MET amplification. Whereas T790M mutation confers prolonged survival and sensitivity to 3rd generation TKIs, data are lacking on clinical features and outcome of MET-driven resistant EGFR-mutated NSCLC patients. Methods: Patients with metastatic EGFR-mutated NSCLC displaying high MET overexpression or MET amplification, detected on a biopsy performed after progression on EGFR TKI, were identified in 15 centers. Clinical and molecular data were retrospectively collected. Results: Forty two patients were included. The median overall survival (OS), and the median post EGFR TKI progression overall survival (PPOS) were 36.2 months [95%CI 27.3-66.5] and 18.5 months [95%CI 10.6-27.4] respectively. Nineteen out of 36 tumors tested for MET FISH had MET amplification. A T790M mutation was found in 11/41 (26.8%) patients. T790M-positive patients had a better OS than T790M-negative patients (p=0.0224). Nineteen patients received a MET TKI. Objective response was reported in 1 out of 12 evaluable patients treated with a MET inhibitor as a single agent and in 1 of 2 patients treated with a combination of MET and EGFR TKIs. Conclusion: MET-driven resistance to EGFR TKI defines a specific pattern of resistance characterized by low objective response rate to MET inhibitors given alone and overlapping with T790M mutations. Further studies are warranted to define adequate therapeutic strategies for MET-driven resistance to EGFR TKI.
Published: 2017

10. Contribution of endocrine therapy in oestrogen receptor-positive pT1a-b breast cancer: Results of a retrospective study

Author: Gilles Houvenaeghel, Alexandre de Nonneville, Monique Cohen, Jean-Marc Classe, Fabien Reyal, Chafika Mazouni, Christelle Faure, Alejandra Martinez, Marie-Pierre Chauvet, Emile Daraï, Charles Coutant, Pierre-Emmanuel Colombo, Pierre Gimbergues, Anne-Sophie Azuar, Roman Rouzier, Christine Tunon de Lara, Patrice Crochet, Sandrine Rua, Anthony Gonçalves, Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Sciences Economiques et Sociales de la Santé & Traitement de l'Information Médicale (SESSTIM - U1252 INSERM - Aix Marseille Univ - UMR 259 IRD), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département de Chirurgie Oncologique [Institut Paoli-Calmettes, Marseille], Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Département de chirurgie, Institut Curie [Paris], CRLCC Jean Godinot, Residual Tumor & Response to Treatment Laboratory [Paris] (RT2Lab), Immunité et cancer (U932), Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Gustave Roussy (IGR), Centre de Recherches en Cancérologie de Toulouse (CRCT), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), Institut du Cancer de Montpellier (ICM), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), Hopital de Grasse, Cancer et génome: Bioinformatique, biostatistiques et épidémiologie d'un système complexe, Mines Paris - PSL (École nationale supérieure des mines de Paris), Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d'oncologie chirurgicale, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Department of Obstetrics and Gynecology, Assistance Publique H^opitaux de Marseille, La Conception Hospital, 13005 Marseille, Aix Marseille University, France, and Aix Marseille Université (AMU)
Subjects: Cancer Research, Receptors, Estrogen, Oncology, Chemotherapy, Adjuvant, Receptor, ErbB-2, [SDV]Life Sciences [q-bio], Humans, Female, Breast Neoplasms, Disease-Free Survival, Retrospective Studies
Abstract: Introduction: Few data have been reported regarding endocrine therapy (ET) in patients with small pT1a-b ER-postive breast cancer (BC). Thus, we conducted a study to detect possible survival improvements due to ET in such patients. Methods: Our retrospective observational study included 5545 patients with pT1a-b ERpositive BC treated in 15 French centres, excluding patients with HER2-positive status, neoadjuvant chemotherapy, ER-negative status, unknown pN status or in situ BC. We estimated disease-free survival (DFS), recurrence-free survival (RFS) and overall survival (OS) via univariate analysis and multivariate Cox regression. Results: Most patients (80.3%: 4453) received ET and-when compared to those without ET -experienced increases of 2.5% and 3.3% in DFS and 1.9% and 4.3% in RFS after 5 and 7 years of follow-up, respectively, with little difference in OS. In Cox regression analysis, no ET was significantly associated with decreased DFS (hazard ratio, HR = 1.275, p = 0.047, 95% CI[1.003-1.620]) but not OS or RFS in all patients, while in 2363 patients with pT1ab ER-positive grade 2-3 BC, no ET was significantly associated with decreased DFS (HR = 1.502, p = 0.049, 95% CI[1.001-2.252]), but not OS (HR = 1.361, p = 0.272). ET omission was not significantly associated with decreased survival in 3047 patients with pT1a-b ER-positive grade 1 BC. Conclusion: Our results indicate that while ET provided a beneficial impact on survival to patients with pT1a-bN0 ER-positive BC-and especially in those with grade 2-3 tumours-no such impact was observed in grade 1 tumours. Consequently, ET should be discussed with these patients, particularly in those with pT1a grade 1 tumours. 2022 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Published: 2022

11. Quelle démarche d’éducation thérapeutique (ETP) pour les adolescents et jeunes adultes atteints de cancer ? Expérience du groupe ETP de « Go-AJA »

Author: Leila Gofti-Laroche, Marielle Retailleau, Nathalie Gaspar, Nadège Corradini, Hélène Sudour-Bonnange, Françoise Rédini, Anne Le Rhun, Loïc Dagorne, Dispositif AJA en cancérologie [Lyon], Centre Léon Bérard [Lyon]-Institut d'hématologie et d'oncologie pédiatrique [CHU - HCL] (IHOPe), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), programme Spécifique de Prise en charge Interdisciplinaire Adolescents et Jeunes Adultes (SPIAJA), Département de cancérologie de l'enfant et de l'adolescent [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Département d'Oncologie Pédiatrique [CHU Nantes], Hôpital Mère-Enfant, CHU de Nantes, Physiopathologie des Adaptations Nutritionnelles (PhAN), Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), équip'AJA [Lille] (Centre Oscar-Lambret), Unité d'oncologie pédiatrique [Centre Oscar Lambret, Lille], Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER, CHU Grenoble, Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble, équipe AJA Arc Alpin [CHU Grenoble Alpes], Centre Hospitalier Universitaire Grenoble Alpes (CHU Grenoble Alpes)-hôpital couple-enfant [CHU Grenoble Alpes], unité d'éducation thérapeutique [CHU Nantes] (Département de santé publique), Centre hospitalier universitaire de Nantes (CHU Nantes)-Hôpital Saint-Jacques [CHU Nantes], maurice, sandrine, Institut National de la Recherche Agronomique (INRA)-Université de Nantes (UN), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER, and Centre Hospitalier Universitaire [Grenoble] (CHU)-hôpital couple-enfant [CHU Grenoble Alpes]
Subjects: Cancer Research, [SDV.MHEP.PED]Life Sciences [q-bio]/Human health and pathology/Pediatrics, Patient care team, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, [SDV.CAN]Life Sciences [q-bio]/Cancer, Hematology, General Medicine, Therapeutic education, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, [SDV.MHEP.PED] Life Sciences [q-bio]/Human health and pathology/Pediatrics, Oncology, [SDV.CAN] Life Sciences [q-bio]/Cancer, 030220 oncology & carcinogenesis, Self care, Radiology, Nuclear Medicine and imaging, 030212 general & internal medicine, Psychology, Humanities, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: Resume Introduction L’allongement de la survie des patients et l’evolution des relations soignants–patients contribuent au developpement de l’education therapeutique du patient (ETP) en onco-hematologie, necessaire notamment pour les patients adolescents et jeunes adultes (AJA) ayant une moindre observance et des difficultes organisationnelles dans leurs parcours de soins. La societe savante « Go-AJA » a structure un groupe de travail assurant la promotion et la structuration d’une demarche d’ETP adaptee aux AJA atteints de cancer. Materiel et methodes Ce groupe de travail national a pu federer des equipes multidisciplinaires formees et engagees dans des actions educatives aupres des AJA et s’est reuni periodiquement entre 2012 et 2015. Resultats Un referentiel de competence a ete construit et adapte a la population des AJA atteints de cancer. Des outils ont ete valides afin d’aider dans les 4 etapes classiques de l’ETP : le diagnostic educatif, l’alliance therapeutique, la mise en œuvre, et l’evaluation. Les competences d’auto-soins ont ete renforcees grâce a des ateliers individuels et/ou collectifs et le developpement des competences d’adaptation a ete integre a ce programme, afin d’ameliorer la coordination et le vecu des therapies. Discussion et conclusion Quels que soient les structures et lieux de soins, l’ETP doit s’integrer dans la prise en charge des AJA en onco-hematologie afin d’ameliorer leur implication et leur vecu de la maladie. Cette premiere experience nationale merite d’etre poursuivie et confortee par des etudes evaluant plus precisement l’impact de tels programmes d’ETP integres au parcours de soins de ces patients AJA atteints de cancer.
Published: 2016

12. Statistical controversies in clinical research: should schedules of tumor size assessments be changed?

Author: Nadine Houede, W. Kouokam, Emmanuelle Tresch-Bruneel, Thomas Filleron, Julia Gilhodes, Alain Duhamel, Florence Joly, Nicolas Penel, Andrew Kramar, Institut Claudius Regaud, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université de Lille-UNICANCER, and Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)
Subjects: 0301 basic medicine, Oncology, medicine.medical_specialty, Biomedical Research, Phases of clinical research, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, time to progression, 03 medical and health sciences, Clinical Trials, Phase II as Topic, 0302 clinical medicine, Neoplasms, Internal medicine, Clinical endpoint, Humans, Medicine, Tumor growth, Tumor size, business.industry, Tumor shrinkage, clinical trial, Hematology, phase II, Tumor Burden, 3. Good health, Surgery, 030104 developmental biology, Clinical research, 030220 oncology & carcinogenesis, Disease Progression, trial design, business, Linear growth, Nadir (topography), end point
Abstract: Background Time to progression (TTP) is often used as a primary end point in phase II clinical trials. Since the actual date of nadir and progression is never known, most calculated TTP are overestimated. This study evaluates the imprecision on the estimate of TTP under two hypothetical tumor kinetic settings and various assessment schedules. Design A two-component tumor growth model was used to account for treatment effect assuming exponential decay for tumor shrinkage and linear growth for progression. Evolution of tumor burden (TB) was modelized according to two scenarios using either a cytotoxic or a cytostatic agent and several assessment schedules. TB, nadir, progression and TTP were simulated for each visit schedule. Results For cytotoxic agents, our model predicted response at 1.5 weeks, a TB at nadir of 40.2 mm (starting from 100 mm) occurring at 6.7 weeks and true progression at 11.2 weeks with a TB of 48.2 mm. For cytostatic agents, our model predicted no response, a TB at nadir of 77 mm occurring at 9.2 weeks and true progression at 19.4 weeks with a TB of 92 mm. Depending on the assessment schedule, estimated TTP was increased from 0.8 to 36.8 weeks and from 0.6 to 28.6 weeks when compared with the true TTP and varied from 5.2% to 298% and from 1.66 to 109.58% when compared with the true TB at progression for cytotoxic and cytostatic agents, respectively. Our model further shows that for cytotoxic agents, evaluation of TB every 6 weeks is optimal to capture the true nadir, the time to nadir, the true progression and the true TTP, whereas for cytostatic agents, this evaluation is optimal every 10 weeks. Conclusions Our results emphasize the importance to estimate the effects of tested drugs on tumor shrinkage before design any phase II clinical trials to choose optimal TB evaluation's timing.
Published: 2016

13. The FREGAT biobank: a clinico-biological database dedicated to esophageal and gastric cancers

Author: Stéphanie Clisant, Florence Renaud, Véronique Christophe, Antoine Adenis, Guillaume Piessen, Christine Delaeter, Malek Dib, Patrick Gelé, Valentin Harter, Emmanuelle Leteurtre, Christophe Mariette, Franck Bonnetain, Marie-Christine Copin, Alain Duhamel, Herrada, Anthony, Hôpital Claude Huriez [Lille], CHU Lille, Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer - U837 (JPArc), Université Lille Nord de France (COMUE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de pathologie [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 (CIC Lille), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université de Lille, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre de Traitement des Données du Cancéropôle Nord-Ouest (CTD-CNO), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Laboratoire Sciences Cognitives et Sciences Affectives - UMR 9193 (SCALab), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer - U1172 Inserm - U837 (JPArc), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Lille Nord de France (COMUE)-Université de Lille, Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Lille Nord de France (COMUE)-UNICANCER, UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193 (SCALab), CNRS, Inserm, Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer - U837 [JPArc], Site de Recherche Intégrée en Cancérologie [SIRIC-ONCOLille], Service de Biologie Moléculaire et Centre de Pathologie [Equipe 1], Centre d'Investigation Clinique - Innovation Technologique de Lille - CIC 1403 - CIC 9301 [CIC Lille], Centre Régional de Lutte contre le Cancer François Baclesse [Caen] [UNICANCER/CRLC], Service d'Oncologie Médicale [CHRU Besançon], Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) [CEF2P / CARCINO], Evaluation des technologies de santé et des pratiques médicales - ULR 2694 [METRICS], and Laboratoire Sciences Cognitives et Sciences Affectives - UMR 9193 [SCALab]
Subjects: Male, Cancer Research, Databases, Factual, Esophageal Neoplasms, Epidemiology, Esophageal cancer, Disease, Study Protocol, 0302 clinical medicine, Prospective Studies, Biological Specimen Banks, Aged, 80 and over, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Prognosis, Biobank, Combined Modality Therapy, 3. Good health, Oncology, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, France, Adult, Quality of life, medicine.medical_specialty, FREGAT, [SDV.CAN]Life Sciences [q-bio]/Cancer, lcsh:RC254-282, 03 medical and health sciences, Therapeutic approach, Young Adult, Quality of life (healthcare), [SDV.CAN] Life Sciences [q-bio]/Cancer, Stomach Neoplasms, Genetics, medicine, Humans, Intensive care medicine, Aged, Internet, business.industry, Research, Cancer, Human and social sciences, Clinico-biological database, medicine.disease, Clinical research, business, Gastric cancer, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: While the incidence of esophageal and gastric cancers is increasing, the prognosis of these cancers remains bleak. Endoscopy and surgery are the standard treatments for localized tumors, but multimodal treatments, associated chemotherapy, targeted therapies, immunotherapy, radiotherapy, and surgery are needed for the vast majority of patients who present with locally advanced or metastatic disease at diagnosis. Although survival has improved, most patients still present with advanced disease at diagnosis. In addition, most patients exhibit a poor or incomplete response to treatment, experience early recurrence and have an impaired quality of life. Compared with several other cancers, the therapeutic approach is not personalized, and research is much less developed. It is, therefore, urgent to hasten the development of research protocols, and consequently, develop a large, ambitious and innovative tool through which future scientific questions may be answered. This research must be patient-related so that rapid feedback to the bedside is achieved and should aim to identify clinical-, biological- and tumor-related factors that are associated with treatment resistance. Finally, this research should also seek to explain epidemiological and social facets of disease behavior. The prospective FREGAT database, established by the French National Cancer Institute, is focused on adult patients with carcinomas of the esophagus and stomach and on whatever might be the tumor stage or therapeutic strategy. The database includes epidemiological, clinical, and tumor characteristics data as well as follow-up, human and social sciences quality of life data, along with a tumor and serum bank. This innovative method of research will allow for the banking of millions of data for the development of excellent basic, translational and clinical research programs for esophageal and gastric cancer. This will ultimately improve general knowledge of these diseases, therapeutic strategies and patient survival. This database was initially developed in France on a nationwide basis, but currently, the database is available for worldwide contributions with respect to the input of patient data or the request for data for scientific projects. The FREGAT database has a dedicated website ( www.fregat-database.org ) and is registered on the Clinicaltrials.gov site, number NCT 02526095 , since August 8, 2015.
Published: 2016

14. Dynamics of Long-Term Patient-Reported Quality of Life and Health Behaviors After Adjuvant Breast Cancer Chemotherapy

Author: Antonio Di Meglio, Julie Havas, Arnauld S. Gbenou, Elise Martin, Mayssam El-Mouhebb, Barbara Pistilli, Gwenn Menvielle, Agnes Dumas, Sibille Everhard, Anne-Laure Martin, Paul H. Cottu, Florence Lerebours, Charles Coutant, Anne Lesur, Olivier Tredan, Patrick Soulie, Laurence Vanlemmens, Florence Joly, Suzette Delaloge, Patricia A. Ganz, Fabrice André, Ann H. Partridge, Lee W. Jones, Stefan Michiels, Ines Vaz-Luis, Institut Gustave Roussy (IGR), Prédicteurs moléculaires et nouvelles cibles en oncologie (PMNCO), Institut Gustave Roussy (IGR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), UNICANCER, Institut Curie [Paris], Institut Curie - Saint Cloud (ICSC), Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), Centre Léon Bérard [Lyon], CRLCC Paul Papin, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Département de médecine oncologique [Gustave Roussy], University of California [Los Angeles] (UCLA), University of California (UC), Dana-Farber Cancer Institute [Boston], Memorial Sloane Kettering Cancer Center [New York], Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Oncostat (U1018 (Équipe 2)), Institut Gustave Roussy (IGR)-Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, and ANR-18-IBHU-0002,PRISM,PRecISion Medicine Institute in oncology(2018)
Subjects: Cancer Research, Prevention, [SDV]Life Sciences [q-bio], Health Behavior, Clinical Sciences, Oncology and Carcinogenesis, Breast Neoplasms, Oncology, Chemotherapy, Adjuvant, Clinical Research, Breast Cancer, Behavioral and Social Science, Quality of Life, Humans, Chemotherapy, Female, Patient Reported Outcome Measures, Oncology & Carcinogenesis, Adjuvant, Cancer
Abstract: PURPOSE We aimed to characterize long-term quality of life (QOL) trajectories among patients with breast cancer treated with adjuvant chemotherapy and to identify related patterns of health behaviors. METHODS Female stage I-III breast cancer patients receiving chemotherapy in CANTO (CANcer TOxicity; ClinicalTrials.gov identifier: NCT01993498 ) were included. Trajectories of QOL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–C30 Summary Score) and associations with trajectory group membership were identified by iterative estimations of group-based trajectory models and multivariable multinomial logistic regression, respectively. RESULTS Four trajectory groups were identified (N = 4,131): excellent (51.7%), very good (31.7%), deteriorating (10.0%), and poor (6.6%) QOL. The deteriorating trajectory group reported fairly good baseline QOL (mean [95% CI], 78.3/100 [76.2 to 80.5]), which significantly worsened at year-1 (58.1/100 [56.4 to 59.9]) and never recovered to pretreatment values through year-4 (61.1/100 [59.0 to 63.3]) postdiagnosis. Healthy behaviors were associated with better performing trajectory groups. Obesity (adjusted odds ratio [aOR] v lean, 1.51 [95% CI, 1.28 to 1.79]; P < .0001) and current smoking (aOR v never, 1.52 [95% CI, 1.27 to 1.82]; P < .0001) at diagnosis were associated with membership to the deteriorating group, which was also characterized by a higher prevalence of patients with excess body weight and insufficient physical activity through year-4 and by frequent exposure to tobacco smoking during chemotherapy. Additional factors associated with membership to the deteriorating group included younger age (aOR, 1-year decrement 1.01 [95% CI, 1.01 to 1.02]; P = .043), comorbidities (aOR v no, 1.22 [95% CI, 1.06 to 1.40]; P = .005), lower income (aOR v wealthier households, 1.21 [95% CI, 1.07 to 1.37]; P = .002), and endocrine therapy (aOR v no, 1.14 [95% CI, 1.01 to 1.30]; P = .047). CONCLUSION This latent-class analysis identified some patients with upfront poor QOL and a high-risk cluster with severe, persistent postchemotherapy QOL deterioration. Screening relevant patient-level characteristics may inform tailored interventions to mitigate the detrimental impact of chemotherapy and preserve QOL, including early addressal of behavioral concerns and provision of healthy lifestyle support programs.
Published: 2022

15. Technical efficiency and complementarity of agroecological innovations in French West Indies banana production

Author: Jean-Joseph Minviel, M’Hand Fares, Jean-Marc Blazy, Alban Thomas, Unité Mixte de Recherche sur les Herbivores - UMR 1213 (UMRH), VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Université Clermont Auvergne (UCA), Systèmes d'élevage méditerranéens et tropicaux (UMR SELMET), Centre de Coopération Internationale en Recherche Agronomique pour le Développement (Cirad)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Institut Agro Montpellier, Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro)-Institut national d'enseignement supérieur pour l'agriculture, l'alimentation et l'environnement (Institut Agro), Agrosystèmes tropicaux (ASTRO), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Paris-Saclay Applied Economics (UMR PSAE), AgroParisTech-Université Paris-Saclay-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Observatoire des Programmes Communautaires de Développement Rural (US ODR), Département de Sénologie, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER, and Systèmes d'Elevage Méditerranéens et Tropicaux - Laboratoire de Recherche sur le Développement de l'Elevage (SELMET-LRDE)
Subjects: Economics and Econometrics, farm performance, agroecological innovations, [QFIN]Quantitative Finance [q-fin], [SDV]Life Sciences [q-bio], [SDE]Environmental Sciences, Conditional efficiency, complementarity, [SHS]Humanities and Social Sciences
Abstract: International audience; In context of global challenges facing agriculture, our article addresses the extent to which the synergistic nature of agroecological innovations may reconcile environmental and technical efficiency of farms. We develop an empirical model, namely conditional efficiency framework, which explicitly accounts for context-dependent drivers like synergy and complementarity of innovations. Using a sample of 567 banana farms in the French West Indies, our estimates confirm the complementarity effect since the joint adoption of agroecological innovations increases the technical efficiency scores much more than other drivers and each of the innovations taken in isolation. We also show that advice and extension services as well as human capital variables are key adoption levers for public policy since they reduce the variability of production and thus the risk associated with the joint adoption of the agroecological innovations.
Published: 2022

16. Achievable Dosimetric Constraints in Stereotactic Reirradiation for Recurrent Prostate Cancer

Author: Baty, Manon, Pasquier, David, Gnep, Khemara, Castelli, Joël, Delaby, Nolewenn, Lacornerie, Thomas, de Crevoisier, Renaud, CRLCC Eugène Marquis (CRLCC), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Laboratoire Traitement du Signal et de l'Image (LTSI), and Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: [SDV.CAN]Life Sciences [q-bio]/Cancer
Abstract: International audience; PURPOSE: Stereotactic body radiation therapy has been proposed as a salvage treatment for recurrent prostate cancer after irradiation. One crucial issue is choosing appropriate dose-volume constraints (DVCs) during planning. The objectives of this study were to (1) quantify the proportion of patients respecting the DVCs according to the Urogenital Tumor Study Group GETUG-31 trial, testing 36 Gy in six fractions, (2) explain geometrically why the DVCs could not be respected, and (3) propose the most suitable DVCs. METHODS AND MATERIALS: This retrospective dosimetric analysis included 141 patients treated for recurrent prostate cancer with Cyberknife (Accuray), according to GETUG-31 DVCs: V(95%) ≥ 95% for the planning target volume (PTV), V(12Gy) < 20% and V(27Gy) < 2 cc for the rectum, and V(12Gy) < 15% and V(27Gy) < 5 cc for the bladder. The percentage of patients not respecting the DVCs was quantified. Correlations between the DVCs and anatomic structures were examined. New DVCs were proposed. RESULTS: Only 19% of patients respected all DVCs, with a mean PTV of 18.5 cc (range, 3-48 cc), although the mean PTV was 40.5 cc (range, 3-174 cc) in the whole series. A total of 98% of the patients with a clinical target volume (CTV)/prostate ratio >0.5 could not respect the DVCs in the organs at risk. The target coverage and organ-at-risk sparing decreased significantly with increase in the values of PTV, CTV, CTV/prostate ratio, the overlapping volume between the PTV and bladder wall and between the PTV and rectal wall. Threshold values of PTV, >20 cc and 40 cc, allowed for the PTV and bladder DVCs, respectively. To improve DVC respect in case of large target volume, we proposed the following new DVCs: V(12Gy) < 25% and 25% and V(27Gy) < 2 cc and 5 cc for the rectum and bladder, respectively. CONCLUSIONS: GETUG-31 DVCs are achievable only for small target volumes (CTV more than half of the prostate). For a larger target volume, new DVCs have been proposed.
Published: 2023

17. Weekly Adaptive Radiotherapy vs Standard Intensity-Modulated Radiotherapy for Improving Salivary Function in Patients With Head and Neck Cancer

Author: Castelli, Joël, Thariat, Juliette, Benezery, Karen, Hasbini, Ali, Gery, Bernard, Berger, Antoine, Liem, Xavier, Guihard, Sébastien, Chapet, Sophie, Thureau, Sébastien, Auberdiac, Pierre, Pommier, Pascal, Ruffier, Amandine, Perrier, Lionel, Devillers, Anne, Campillo-Gimenez, Boris, de Crevoisier, Renaud, CRLCC Eugène Marquis (CRLCC), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Laboratoire de physique corpusculaire de Caen (LPCC), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-École Nationale Supérieure d'Ingénieurs de Caen (ENSICAEN), Normandie Université (NU)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Centre National de la Recherche Scientifique (CNRS), Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Clinique Pasteur-Lanroze (FRANCE), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Institut de Cancérologie de Strasbourg Europe (ICANS), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Clinique Claude Bernard - ELSAN [Albi] (CCBE), Centre Léon Bérard [Lyon], Université de Lyon, and This study was sponsored by the Cancer Institute Eugène Marquis, Rennes, France, and grant PAIR VADS 2011 (Prof de Crevoisier) from the French National Cancer Institute.
Subjects: [SDV.IB]Life Sciences [q-bio]/Bioengineering, [SDV.CAN]Life Sciences [q-bio]/Cancer
Abstract: International audience; Importance: Xerostomia is a major toxic effect associated with intensity-modulated radiotherapy (IMRT) for oropharyngeal cancers.Objective: To assess whether adaptive radiotherapy (ART) improves salivary function compared with IMRT in patients with head and neck cancer.Design, setting, and participants: This phase 3 randomized clinical trial was conducted in 11 French centers. Patients aged 18 to 75 years with stage III-IVB squamous cell oropharyngeal cancer treated with chemoradiotherapy were enrolled between July 5, 2013, and October 1, 2018. Data were analyzed from November 2021 to May 2022.Interventions: The patients were randomly assigned (1:1) to receive standard IMRT (without replanning) or ART (systematic weekly replanning).Main outcomes and measures: The primary end point was the frequency of xerostomia, measured by stimulating salivary flow with paraffin. Secondary end points included salivary gland excretory function measured using technetium-99m pertechnetate scintigraphy, patient-reported outcomes (Eisbruch xerostomia-specific questionnaire and the MD Anderson Symptom Inventory for Head and Neck Cancer questionnaire), early and late toxic effects, disease control, and overall and cancer-specific survival.Results: A total of 132 patients were randomized, and after 1 exclusion in the ART arm, 131 were analyzed: 66 in the ART arm (mean [SD] age at inclusion, 60 [8] years; 57 [86.4%] male) and 65 in the standard IMRT arm (mean [SD] age at inclusion, 60 [8] years; 57 [87.7%] male). The median follow-up was 26.4 months (IQR, 1.2-31.3 months). The mean (SD) salivary flow (paraffin) at 12 months was 630 (450) mg/min in the ART arm and 584 (464) mg/min in the standard arm (P = .64). The mean (SD) excretory function of the parotid gland at 12 months, measured by scintigraphy, improved in the ART arm (48% [17%]) compared with the standard arm (41% [17%]) (P = .02). The 2-year-overall survival was 76.9% (95% CI, 64.7%-85.4%) in both arms.Conclusions and relevance: This randomized clinical trial did not demonstrate a benefit of ART in decreasing xerostomia compared with standard IMRT. No significant differences were found in secondary end points except for parotid gland excretory function, as assessed by scintigraphy, or in survival rates.Trial registration: ClinicalTrials.gov Identifier: NCT01874587.
Published: 2023

18. Genes Involved in miRNA Biogenesis Are Not Downregulated in SARS-CoV-2 Infection

Author: Nathalie Garnier, Famara Sane, Layal Massara, Fabrice Soncin, Philippe Gosset, Didier Hober, Sabine Szunerits, Ilka Engelmann, Pathogenèse virale du diabète de type 1 - ULR 3610 (Laboratoire de Virologie), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut d’Électronique, de Microélectronique et de Nanotechnologie - UMR 8520 (IEMN), Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS)-Université Polytechnique Hauts-de-France (UPHF)-JUNIA (JUNIA), Université catholique de Lille (UCL)-Université catholique de Lille (UCL), CHU Lille, Centre d’Infection et d’Immunité de Lille - INSERM U 1019 - UMR 9017 - UMR 8204 (CIIL), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS), Laboratory for Integrated Micro Mechatronics Systems (LIMMS), The University of Tokyo (UTokyo)-Centre National de la Recherche Scientifique (CNRS), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, NanoBioInterfaces - IEMN (NBI - IEMN), Université catholique de Lille (UCL)-Université catholique de Lille (UCL)-Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS)-Université Polytechnique Hauts-de-France (UPHF)-JUNIA (JUNIA), Pathogenesis and Control of Chronic and Emerging Infections (PCCEI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université des Antilles (UA)-Etablissement français du don du sang [Montpellier]-Université de Montpellier (UM), CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), This research was supported by I-SITE ULNE, the Centre Hospitalier Universitaire de Lilleand Université de Lille. N.G. wants to thank the Ecole Doctorale Biologie-Santé for a PhD fellowship., and ANR-16-IDEX-0004,ULNE,ULNE(2016)
Subjects: [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, Ago2, SARS-CoV-2, Exportin-5, COVID-19, Drosha, DGCR8, Infectious Diseases, RNA interference, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Virology, [SDV.BBM.GTP]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Genomics [q-bio.GN], [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, miRNA, Dicer
Abstract: International audience; miRNAs, small non-coding RNAs that regulate gene expression, are involved in various pathological processes, including viral infections. Virus infections may interfere with the miRNA pathway through the inhibition of genes involved in miRNA biogenesis. A reduction in the number and the levels of miRNAs expressed in nasopharyngeal swabs of patients with severe COVID-19 was lately observed by us, pointing towards the potential of miRNAs as possible diagnostic or prognostic biomarkers for predicting outcomes among patients with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. The objective of the present study was to investigate whether SARS-CoV-2 infection influences the expression levels of messenger RNAs (mRNAs) of key genes involved in miRNA biogenesis. mRNA levels of AGO2, DICER1, DGCR8, DROSHA, and Exportin-5 (XPO5) were measured by quantitative reverse-transcription polymerase chain reaction (RT-qPCR) in nasopharyngeal swab specimens from patients with COVID-19 and controls, as well as in cells infected with SARS-CoV-2 in vitro. Our data showed that the mRNA expression levels of AGO2, DICER1, DGCR8, DROSHA, and XPO5 were not significantly different in patients with severe COVID-19 when compared to patients with non-severe COVID-19 and controls. Similarly, the mRNA expression of these genes was not affected by SARS-CoV-2 infection in NHBE and Calu-3 cells. However, in Vero E6 cells, AGO2, DICER1, DGCR8, and XPO5 mRNA levels were slightly upregulated 24 h after infection with SARS-CoV-2. In conclusion, we did not find evidence for downregulation of mRNA levels of miRNA biogenesis genes during SARS-CoV-2 infection, neither ex vivo nor in vitro.
Published: 2023

19. Surface imaging, laser positioning or volumetric imaging for breast cancer with nodal involvement treated by helical TomoTherapy

Author: Frederik Crop, Lena Bequet, Amandine Baczkiewic, Emeline Steux, Mathilde Lacour, Laurence Muszynski, Julie Doré, Clement Florence, Eric Lartigau, David Pasquier, Jacqueline Bouillon, Anne Gadroy, Méthodes et Outils pour la Conception Intégrée de Systèmes (MOCIS), Centre de Recherche en Informatique, Signal et Automatique de Lille - UMR 9189 (CRIStAL), Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS)-Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS), Physique médicale, Service de radiothérapie / curiethérapie, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER, Université Lille Nord de France (COMUE)-UNICANCER, Université de Lille-UNICANCER-Université de Lille-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER, and Université de Lille-UNICANCER
Subjects: Volumetric imaging, Positioning system, medicine.medical_treatment, Movement, [SDV]Life Sciences [q-bio], tomotherapy, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Tomotherapy, Standard deviation, Patient Positioning, 030218 nuclear medicine & medical imaging, law.invention, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, breast cancer, law, Image Processing, Computer-Assisted, Medicine, Humans, Radiation Oncology Physics, Radiology, Nuclear Medicine and imaging, Instrumentation, radiotherapy, ComputingMilieux_MISCELLANEOUS, Nodal involvement, Radiation, business.industry, Lasers, Radiotherapy Planning, Computer-Assisted, Radiotherapy Dosage, image‐guided radiotherapy, medicine.disease, Laser, 3. Good health, 030220 oncology & carcinogenesis, Lymphatic Metastasis, Female, Tomography, Lymph Nodes, Radiotherapy, Conformal, business, Nuclear medicine, Tomography, Spiral Computed
Abstract: A surface imaging system, Catalyst (C‐Rad), was compared with laser‐based positioning and daily mega voltage computed tomography (MVCT) setup for breast patients with nodal involvement treated by helical TomoTherapy. Catalyst‐based positioning performed better than laser‐based positioning. The respective modalities resulted in a standard deviation (SD), 68% confidence interval (CI) of positioning of left–right, craniocaudal, anterior–posterior, roll: 2.4 mm, 2.7 mm, 2.4 mm, 0.9° for Catalyst positioning, and 6.1 mm, 3.8 mm, 4.9 mm, 1.1° for laser‐based positioning, respectively. MVCT‐based precision is a combination of the interoperator variability for MVCT fusion and the patient movement during the time it takes for MVCT and fusion. The MVCT fusion interoperator variability for breast patients was evaluated at one SD left–right, craniocaudal, ant–post, roll as: 1.4 mm, 1.8 mm, 1.3 mm, 1.0°. There was no statistically significant difference between the automatic MVCT registration result and the manual adjustment; the automatic fusion results were within the 95% CI of the mean result of 10 users, except for one specific case where the patient was positioned with large yaw. We found that users add variability to the roll correction as the automatic registration was more consistent. The patient position uncertainty confidence interval was evaluated as 1.9 mm, 2.2 mm, 1.6 mm, 0.9° after 4 min, and 2.3 mm, 2.8 mm, 2.2 mm, 1° after 10 min. The combination of this patient movement with MVCT fusion interoperator variability results in total standard deviations of patient position when treatment starts 4 or 10 min after initial positioning of, respectively: 2.3 mm, 2.8 mm, 2.0 mm, 1.3° and 2.7 mm, 3.3 mm, 2.6 mm, 1.4°. Surface based positioning arrives at the same precision when taking into account the time required for MVCT imaging and fusion. These results can be used on a patient‐per‐patient basis to decide which positioning system performs the best after the first 5 fractions and when daily MVCT can be omitted. Ideally, real‐time monitoring is required to reduce important intrafraction movement. PACS number(s): 87.53.Jw, 87.53.Kn, 87.56.Da, 87.63.L‐, 81.70.Tx
Published: 2016

20. Reporting adverse events in cancer surgery randomized trials: A systematic review of published trials in oesophago-gastric and gynecological cancer patients

Author: Alain Duhamel, Pierre Collinet, Fabrice Narducci, Nicolas Penel, Christophe Mariette, Leila Meghelli, Marie Vanseymortier, Guillaume Piessen, Eric Leblanc, Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Hôpital Claude Huriez [Lille], CHU Lille, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Hôpital Jeanne de Flandres, Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Lille Nord de France (COMUE)-UNICANCER, Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), and SALZET, Michel
Subjects: medicine.medical_specialty, Post-operative complications, Esophageal Neoplasms, Genital Neoplasms, Female, [SDV]Life Sciences [q-bio], Population, law.invention, 03 medical and health sciences, 0302 clinical medicine, Cancer surgery, Clinical trials, Gynecologic Surgical Procedures, Randomized controlled trial, law, Stomach Neoplasms, Internal medicine, medicine, Humans, 030212 general & internal medicine, Adverse effect, education, Digestive System Surgical Procedures, Randomized Controlled Trials as Topic, education.field_of_study, Toxicity, business.industry, Consolidated Standards of Reporting Trials, Cancer, Hematology, medicine.disease, Gynecological cancer, 3. Good health, Surgery, [SDV] Life Sciences [q-bio], Clinical trial, Oncology, 030220 oncology & carcinogenesis, Female, business, Adverse events reporting
Abstract: International audience; Background: Few reports describe how adverse events (AEs) are reported in cancer surgery trials.Materials and methods: We systematically reviewed 179 consecutive study reports issued between January 1, 1990 and November 15, 2014, which investigated surgery in oesophago-gastric (OG) or gynecologic (GY) cancer patients. Based on the reviewed reports, we assessed how AEs were reported according to CONSORT statement.Results: Morbidity assessment was the primary objective of 56 studies (31.3%). Postoperative AEs were described in 161 studies (90%). Definition of AEs and grading scale (NCI-CTC AE, Dindo-Clavien scale, etc …) were given in 27.3% and 16.8% of studies, respectively. AEs were reported by event and grade in 8.3% of studies. Definition of expectedness, seriousness, causality and safety population were present in 0.5%, 1.1%, 7.8%, and 7.2% of the studies, respectively. Reporting of AEs did not improve over time nor better in high-impact factor journals.Conclusion: The reporting of AEs in cancer trials investigating surgery needs to be improved.
Published: 2016

21. Crossed views of burden and emotional distress of cancer patients and family caregivers during palliative care

Author: Leroy, Tanguy, Fournier, Emmanuelle, Penel, Nicolas, Christophe, Véronique, Greps, Laboratoire, Groupe de Recherche en Psychologie Sociale (GRePS), Université Lumière - Lyon 2 (UL2), Laboratoire Sciences Cognitives et Sciences Affectives - UMR 9193 (SCALab), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Unité de Recherche en Sciences Cognitives et Affectives (URECA), Université de Lille, Sciences Humaines et Sociales-PRES Université Lille Nord de France, Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193 (SCALab), Université Lille Nord de France (COMUE)-UNICANCER, and Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
Subjects: [SHS.PSY] Humanities and Social Sciences/Psychology, caregiver burden, emotional distress, palliative care, Health, self-perceived burden, oncology, cancer, [SHS.PSY]Humanities and Social Sciences/Psychology, social psychology
Abstract: International audience; Objective. Studies regarding natural caregivers’ burden (CB) in palliative situations, as well as its determinants and consequences, have been numerous during the last twenty years. Yet, studies regarding how terminally-ill cancer patients perceive their caregivers’ burden (self-perceived burden, SPB) are less common. This study aims to assess the links between CB and SPB evaluated by means of the very same items. It also aims at identifying the determinants of potential differences between CB and SPB and their consequences on emotional distress among both members of the dyad.Methods. Sixty cancer patients from a palliative care unit and their principal natural caregiver completed questionnaires concerning the subjective burden of the caregiver, their own personal emotional distress and that of the other member of the dyad.Results. Globally, patients had a good perception of their caregivers’ burden, although a little overestimated, except for their difficulties in managing their time. Caregivers overestimated patients’ distress. The minimisation by patients of caregivers’ burden was a source of emotional distress for the latter, and the perception of being a burden to others was a source of depression for patients. These results did not depend on the nature of the relationship between patients and their caregivers.Conclusions. This data confirmed the need to study the experiences of the patient-caregiver dyad as well as their communication of their respective experiences, with a prospect to offer clinical interventions to optimise the quality of life and health of patients and their close relatives.
Published: 2016

22. Evaluate the subjective experience of the disease and its treatment in the partners of young women with non-metastatic breast cancer

Author: Véronique Christophe, A. Lesur, Emmanuelle Fournier, Christelle Duprez, Anne Congard, Pascal Antoine, L. Vanlemmens, Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193 (SCALab), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre de Recherche en Psychologie de la Connaissance, du Langage et de l'Émotion (PsyCLÉ), Aix Marseille Université (AMU), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Laboratoire Sciences Cognitives et Sciences Affectives - UMR 9193 (SCALab), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), and Université de Lille-UNICANCER
Subjects: Adult, Male, Career management, Antineoplastic Agents, Hormonal, media_common.quotation_subject, caregiving, Concurrent validity, [SHS.PSY]Humanities and Social Sciences/Psychology, Breast Neoplasms, Disease, Breast Cancer Inventory, Negative affectivity, 03 medical and health sciences, partner, 0302 clinical medicine, Breast cancer, Quality of life, Surveys and Questionnaires, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Interpersonal Relations, 030212 general & internal medicine, Everyday life, media_common, Aged, young women, business.industry, Reproducibility of Results, Middle Aged, Trastuzumab, medicine.disease, Self Concept, 3. Good health, Sexual Partners, Oncology, Feeling, quality of life, 030220 oncology & carcinogenesis, [SCCO.PSYC]Cognitive science/Psychology, Female, France, business, Clinical psychology
Abstract: International audience; Evaluate the subjective experience of the disease and its treatment in the partners of young women with non-metastatic breast cancer The impact of the disease experience on the quality of life of the relatives of patients with cancer is now well documented. However, few scales specifically address the partners' subjective quality of life. This study aims to validate a questionnaire assessing the impact of cancer on the quality of life of the partners of young women with breast cancer. Partners (n = 499) of women aged
Published: 2016

23. Guidelines for the definition of time-to-event end points in renal cell cancer clinical trials: results of the DATECAN project

Author: D. Quinn, Pascal Wolter, J. Fitzpatrick, Peter F.A. Mulders, S. Negrier, S. Crabb, David Pasquier, G. Gravis, Bertrand Tombal, Thomas Powles, Didier Jacqmin, Alessandro Volpe, A. Kramar, A. Ravaud, Alain Ravaud, S. Joniau, Timothy Eisen, Christophe Massard, Peter J. Goebell, J. Catto, Andrew Kramar, P.J. Goebell, C. Porta, James W.F. Catto, Elodie Vauleon, Alberto Bossi, T. Filleron, B. Melichar, David I. Quinn, E. Vauleon, Franck Bonnetain, Axel Bex, Simon J. Crabb, Thomas Filleron, Diego Tosi, Manuela Schmidinger, Sergio Braccarda, P. Nathan, R. Bukowski, Tim Eisen, D. Pasquier, R. Sylvester, Bernard Escudier, Ronald M. Bukowski, B. Malavaud, N. Houede, V. Flamand, A. Bex, T.K. Choueiri, Mounira El Demery, L. Mourey, D. Tosi, N. Houédé, P. Mulders, Richard Sylvester, Sylvie Negrier, P. Wolter, Gwendael Gravis, Bernard Malavaud, John M. Fitzpatrick, Vincent Flamand, T. Powles, A. Volpe, Paul Nathan, D. Pouessel, A. Bossi, Richard Kaplan, F. Rolland, R. Kaplan, F. Bonnetain, Frédéric Rolland, S. Bracarda, Camillo Porta, Damien Pouessel, M. Schmidinger, M. El Demery, D. Jacqmin, Loïc Mourey, Toni K. Choueiri, Bohuslav Melichar, Steven Joniau, B. Escudier, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Department of Medical Oncology [Lyon], Centre Léon Bérard [Lyon], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Service d'Oncologie Médicale [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Département de radiothérapie [Gustave Roussy], Institut Gustave Roussy (IGR), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Université Lille Nord de France (COMUE), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), CHU Strasbourg, Service d'Urologie - Transplantation Rénale - Andrologie, CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Département d'oncologie médicale, Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Hémato-oncologie [CHU Saint-Louis], Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Saint-André, CRLCC René Gauducheau, Département d'oncologie Médicale, CRLCC Val d'Aurelle - Paul Lamarque, Département d'oncologie médicale [Rennes], CRLCC Eugène Marquis (CRLCC), Université de Lille-UNICANCER, Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Département d'Urologie-Andrologie et Transplantation Rénale [CHU Toulouse], Pôle Urologie - Néphrologie - Dialyse - Transplantations - Brûlés - Chirurgie plastique - Explorations fonctionnelles et physiologiques [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), and Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)
Subjects: Oncology, medicine.medical_specialty, Delphi Technique, Endpoint Determination, Delphi method, [SDV.CAN]Life Sciences [q-bio]/Cancer, Disease, renal cell cancer, Disease-Free Survival, time-to-event end points, Renal cell carcinoma, Internal medicine, Urological cancers Radboud Institute for Molecular Life Sciences [Radboudumc 15], Medicine, Humans, Carcinoma, Renal Cell, Randomized Controlled Trials as Topic, Protocol (science), clinical trials, Surrogate endpoint, business.industry, Cancer, Hematology, medicine.disease, Kidney Neoplasms, 3. Good health, Surgery, Clinical trial, recommendations, Guideline Adherence, Neoplasm Recurrence, Local, business, Kidney cancer, DATECAN
Abstract: Item does not contain fulltext BACKGROUND: In clinical trials, the use of intermediate time-to-event end points (TEEs) is increasingly common, yet their choice and definitions are not standardized. This limits the usefulness for comparing treatment effects between studies. The aim of the DATECAN Kidney project is to clarify and recommend definitions of TEE in renal cell cancer (RCC) through a formal consensus method for end point definitions. MATERIALS AND METHODS: A formal modified Delphi method was used for establishing consensus. From a 2006-2009 literature review, the Steering Committee (SC) selected 9 TEE and 15 events in the nonmetastatic (NM) and metastatic/advanced (MA) RCC disease settings. Events were scored on the range of 1 (totally disagree to include) to 9 (totally agree to include) in the definition of each end point. Rating Committee (RC) experts were contacted for the scoring rounds. From these results, final recommendations were established for selecting pertinent end points and the associated events. RESULTS: Thirty-four experts scored 121 events for 9 end points. Consensus was reached for 31%, 43% and 85% events during the first, second and third rounds, respectively. The expert recommend the use of three and two endpoints in NM and MA setting, respectively. In the NM setting: disease-free survival (contralateral RCC, appearance of metastases, local or regional recurrence, death from RCC or protocol treatment), metastasis-free survival (appearance of metastases, regional recurrence, death from RCC); and local-regional-free survival (local or regional recurrence, death from RCC). In the MA setting: kidney cancer-specific survival (death from RCC or protocol treatment) and progression-free survival (death from RCC, local, regional, or metastatic progression). CONCLUSIONS: The consensus method revealed that intermediate end points have not been well defined, because all of the selected end points had at least one event definition for which no consensus was obtained. These clarified definitions of TEE should become standard practice in all RCC clinical trials, thus facilitating reporting and increasing precision in between trial comparisons.
Published: 2015

24. CANTO-RT: One of the Largest Prospective Multicenter Cohort of Early Breast Cancer Patients Treated with Radiotherapy including Full DICOM RT Data

Author: Thomas Sarrade, Rodrigue Allodji, Youssef Ghannam, Guillaume Auzac, Sibille Everhard, Youlia Kirova, Karine Peignaux, Philippe Guilbert, David Pasquier, Séverine Racadot, Céline Bourgier, Sandrine Ducornet, Fabrice André, Florent De Vathaire, Sofia Rivera, Institut Gustave Roussy (IGR), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, UNICANCER, Institut Curie [Paris], Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), Institut Jean Godinot [Reims], Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre Léon Bérard [Lyon], Institut du Cancer de Montpellier (ICM), Radiothérapie Moléculaire et Innovation Thérapeutique (RaMo-IT), Institut Gustave Roussy (IGR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Agence Nationale de la Recherche, ANR: ANR-10-COHO-0004, The CANTO cohort (NCT01993498) was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board of UNICANCER (UC-0140/1103). The CANTO cohort was supported by the Agence Nationale pour la Recherche (ANR-10-COHO-0004). The study was approved by French regulatory authorities Afssaps under the reference: B111158-20 on 14 September 2011 and French ethics committee ID- RCB:2011- A01095- 36,11- 039 on 14 October 2011., and The CANTO cohort is supported by grants from Odyssea and Foundation Gustave Roussy. This work was also supported by the French Government under the Investment for the Future program managed by the National Research Agency (ANR), Grant No. ANR-10-COHO-0004 (CANTO).
Subjects: Cancer Research, toxicities’ predictive factors, Oncology, [SDV.CAN]Life Sciences [q-bio]/Cancer, early breast cancer, radiotherapy
Abstract: International audience; This article describes the methodology used and provides a characterization of the study population in CANTO-RT (CANcer TOxicities RadioTherapy). CANTO (NCT01993498) is a prospective clinical cohort study including patients with stage I-III BC from 26 French cancer centers. Patients matching all CANTO inclusion and exclusion criteria who received RT in one of the 10 top recruiting CANTO centers were selected. Individual full DICOM RT files were collected, pseudo-anonymized, structured and analyzed on the CANTO-RT/UNITRAD web platform. CANTO-RT included 3875 BC patients with a median follow-up of 64 months. Among the 3797 patients with unilateral RT, 3065 (80.4%) had breast-conserving surgery, and 2712 (71.5%) had sentinel node surgery. Tumor bed boost was delivered in 2658 patients (68.5%) and lymph node RT in 1356 patients (35%), including internal mammary chain in 844 patients (21.8%). Most patients (3691 (95.3%)) were treated with 3D conformal RT. Target volumes, organs at risk contours and dose/volume histograms were extracted after quality-control procedures. CANTO-RT is one of the largest early BC prospective cohorts with full individual clinical, biological, imaging and DICOM RT data available. It is a valuable resource for the identification and validation of clinical and dosimetric predictive factors of RT and multimodal treatment-related toxicities.
Published: 2023
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25. Intracranial Solitary Fibrous Tumour Management: A French Multicentre Retrospective Study

Author: Marine Lottin, Alexandre Escande, Luc Bauchet, Marie Albert-Thananayagam, Maël Barthoulot, Matthieu Peyre, Mathieu Boone, Sonia Zouaoui, Jacques Guyotat, Guillaume Penchet, Johan Pallud, Henry Dufour, Evelyne Emery, Michel Lefranc, Sébastien Freppel, Houman Namaki, Edouard Gueye, Jean-Jacques Lemaire, Bertrand Muckensturm, Robin Srour, Stéphane Derrey, Apolline Monfilliette, Jean-Marc Constans, Claude-Alain Maurage, Bruno Chauffert, Nicolas Penel, CHU Amiens-Picardie, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Faculté de Médecine Henri Warembourg - Université de Lille, Centre de Recherche en Informatique, Signal et Automatique de Lille - UMR 9189 (CRIStAL), Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS), Neurochirurgie [Hôpital Gui de Chauliac], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [CHU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), Registre des Tumeurs de l'Hérault, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHirurgie, IMagerie et REgénération tissulaire de l’extrémité céphalique - Caractérisation morphologique et fonctionnelle - UR UPJV 7516 (CHIMERE), Université de Picardie Jules Verne (UPJV), Hospices Civils de Lyon (HCL), CHU Bordeaux [Bordeaux], Hôpital d'Instruction des Armées Sainte Anne, Service de Santé des Armées, Hôpital de la Timone [CHU - APHM] (TIMONE), Service de Neurochirurgie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital saint Pierre, GH Sud Réunion, Hôpital de Perpignan, Centre Hospitalier Saint Jean de Perpignan, CHU Limoges, Service de Neurochirurgie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre Hospitalier Régional d'Orléans (CHRO), Hôpitaux Civils de Colmar, Service de neurochirurgie [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Service d'oncologie médicale (CHRU Lille), and Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
Subjects: surgery, Cancer Research, intracranial, recurrence, Oncology, solitary fibrous tumour, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], hemangiopericytoma, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; Background: Intracranial solitary fibrous tumour (iSFT) is an exceptional mesenchymal tumour with high recurrence rates. We aimed to analyse the clinical outcomes of newly diagnosed and recurrent iSFTs.Methods: We carried out a French retrospective multicentre (n = 16) study of histologically proven iSFT cases. Univariate and multivariate Cox models were used to estimate the prognosis value of the age, location, size, WHO grade, and surgical extent on overall survival (OS), progression-free survival (PFS), and local recurrence-free survival (LRFS).Results: Eighty-eight patients were included with a median age of 54.5 years. New iSFT cases were treated with gross tumour resection (GTR) (n = 75) or subtotal resection (STR) (n = 9) and postoperative radiotherapy (PORT) (n = 32, 57%). The median follow-up time was 7 years. The median OS, PFS, and LRFS were 13 years, 7 years, and 7 years, respectively. Forty-two patients experienced recurrence. Extracranial metastasis occurred in 16 patients. Median OS and PFS after the first recurrence were 6 years and 15.4 months, respectively. A higher histological grade was a prognosis factor for PFS (p = 0.04) and LRFS (p = 0.03). GTR influenced LRFS (p = 0.03).Conclusion: GTR provided benefits as a first treatment for iSFTs. However, approximately 40% of patients experienced relapse, which remains a challenging state.
Published: 2023
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26. NALCN-mediated sodium influx confers metastatic prostate cancer cell invasiveness

Author: Folcher, Antoine, Gordienko, Dmitri, Iamshanova, Oksana, Bokhobza, Alexandre, Shapovalov, George, Kannancheri-Puthooru, Dheeraj, Mariot, Pascal, Allart, Laurent, Desruelles, Emilie, Spriet, Corentin, Diez, Raquel, Oullier, Thibauld, Marionneau-Lambot, Séverine, Brisson, Lucie, Geraci, Sandra, Impheng, Hathaichanok, Lehen'Kyi, V'Yacheslav, Haustrate, Aurélien, Mihalache, Adriana, Gosset, Pierre, Chadet, Stéphanie, Retif, Stéphanie, Laube, Maryline, Sobilo, Julien, Lerondel, Stéphanie, Villari, Giulia, Serini, Guido, Pla, Alessandra Fiorio, Roger, Sébastien, Fromont-Hankard, Gaelle, Djamgoz, Mustafa, Clezardin, Philippe, Monteil, Arnaud, Prevarskaya, Natalia, Laboratoire de Physiologie Cellulaire : Canaux ioniques, inflammation et cancer - U 1003 (PHYCELL), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Unité de Glycobiologie Structurale et Fonctionnelle - UMR 8576 (UGSF), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Universidad de Extremadura - University of Extremadura (UEX), Cancéropôle du Grand Ouest, Université de Nantes (UN), Nutrition, croissance et cancer (U 1069) (N2C), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiopathologie, diagnostic et traitements des maladies osseuses / Pathophysiology, Diagnosis & Treatments of Bone Diseases (LYOS), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Naresuan University, Université catholique de Lille (UCL), EA4245 - Transplantation, Immunologie, Inflammation [Tours] (T2i), Université de Tours (UT), Transgenèse et archivage d'animaux modèles (TAAM), Centre National de la Recherche Scientifique (CNRS), French National Infrastructure for Mouse Phenogenomics (PHENOMIN), Centre d'Imagerie du Petit Animal (CIPA), Université d'Orléans (UO), Università degli studi di Torino = University of Turin (UNITO), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Imperial College London, Cyprus International University, Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), LabEx Ion Channels Science and Therapeutics [France], and ANR-11-LABX-0015,ICST,Canaux ioniques d'intérêt thérapeutique(2011)
Subjects: Sodium leak channel, calcium oscillations, invasion, oncochannelopathy, vesicle secretion, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.BC.BC]Life Sciences [q-bio]/Cellular Biology/Subcellular Processes [q-bio.SC], [SDV.MHEP.UN]Life Sciences [q-bio]/Human health and pathology/Urology and Nephrology
Abstract: International audience; There is growing evidence that ion channels are critically involved in cancer cell invasiveness and metastasis. However, the molecular mechanisms of ion signaling promoting cancer behavior are poorly understood and the complexity of the underlying remodeling during metastasis remains to be explored. Here, using a variety of in vitro and in vivo techniques, we show that metastatic prostate cancer cells acquire a specific Na+ /Ca2+ signature required for persistent invasion. We identify the Na+ leak channel, NALCN, which is overexpressed in metastatic prostate cancer, as a major initiator and regulator of Ca2+ oscillations required for invadopodia formation. Indeed, NALCN-mediated Na+ influx into cancer cells maintains intracellular Ca2+ oscillations via a specific chain of ion transport proteins including plasmalemmal and mitochondrial Na+ /Ca2+ exchangers, SERCA and store-operated channels. This signaling cascade promotes activity of the NACLN-colocalized proto-oncogene Src kinase, actin remodeling and secretion of proteolytic enzymes, thus increasing cancer cell invasive potential and metastatic lesions in vivo. Overall, our findings provide new insights into an ion signaling pathway specific for metastatic cells where NALCN acts as persistent invasion controller.
Published: 2023

27. Efficiency and Accuracy Evaluation of Multiple Diffusion‐Weighted MRI Techniques Across Different Scanners

Author: Crop, Frederik, Robert, Clémence, Viard, Romain, Dumont, Julien, Kawalko, Marine, Makala, Pauline, Liem, Xavier, El Aoud, Imen, Ben Miled, Aicha, Chaton, Victor, Patin, Lucas, Pasquier, David, Guillaud, Ophélie, Vandendorpe, Benjamin, Mirabel, Xavier, Ceugnart, Luc, Decoene, Camille, Lacornerie, Thomas, Physique - IEMN (PHYSIQUE - IEMN), Institut d’Électronique, de Microélectronique et de Nanotechnologie - UMR 8520 (IEMN), Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS)-Université Polytechnique Hauts-de-France (UPHF)-JUNIA (JUNIA), Université catholique de Lille (UCL)-Université catholique de Lille (UCL)-Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS)-Université Polytechnique Hauts-de-France (UPHF)-JUNIA (JUNIA), Université catholique de Lille (UCL)-Université catholique de Lille (UCL), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Plateformes Lilloises en Biologie et Santé - UAR 2014 - US 41 (PLBS), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS), Lille Neurosciences & Cognition - U 1172 (LilNCog), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Laboratoire Psychologie de la Socialisation - Développement et Travail (LPS-DT), Université Toulouse - Jean Jaurès (UT2J), Université de Toulouse (UT)-Université de Toulouse (UT), Centre de Recherche en Informatique, Signal et Automatique de Lille - UMR 9189 (CRIStAL), Centrale Lille-Université de Lille-Centre National de la Recherche Scientifique (CNRS), and Contract grant sponsor: Cancéropôle Nord-Ouest (CNO)
Subjects: [SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging, [PHYS.PHYS.PHYS-MED-PH]Physics [physics]/Physics [physics]/Medical Physics [physics.med-ph]
Abstract: International audience; Background The choice between different diffusion-weighted imaging (DWI) techniques is difficult as each comes with tradeoffs for efficient clinical routine imaging and apparent diffusion coefficient (ADC) accuracy.Purpose: To quantify signal-to-noise-ratio (SNR) efficiency, ADC accuracy, artifacts, and distortions for different DWI acquisition techniques, coils, and scanners.Study Type: Phantom, in vivo intraindividual biomarker accuracy between DWI techniques and independent ratings.Population/Phantoms: NIST diffusion phantom. 51 Patients: 40 with prostate cancer and 11 with head-and-neck cancer at 1.5 TField Strength/Sequence: Echo planar imaging (EPI): 1.5 T and 3 T Siemens; 3 T Philips. Distortion-reducing: RESOLVE (1.5 and 3 T Siemens); Turbo Spin Echo (TSE)-SPLICE (3 T Philips). Small field-of-view (FOV): ZoomitPro (1.5 T Siemens); IRIS (3 T Philips). Head-and-neck and flexible coils.Assessment: SNR Efficiency, geometrical distortions, and susceptibility artifacts were quantified for different b-values in a phantom. ADC accuracy/agreement was quantified in phantom and for 51 patients. In vivo image quality was independently rated by four experts.Statistical Tests: QIBA methodology for accuracy: trueness, repeatability, reproducibility, Bland–Altman 95% Limits-of-Agreement (LOA) for ADC. Wilcoxon Signed-Rank and student tests on P
Published: 2023

28. Late toxicity comparison of alkylating-based maintenance regimen with cyclophosphamide (VAC) vs ifosfamide (VAI) in Ewing sarcoma survivors treated in the randomized clinical trial Euro-EWING99-R1 in France

Author: Victoria, Corvest, Perrine, Marec-Bérard, Cyril, Lervat, Hélène, Pacquement, Maud, Toulmonde, Jean-Claude, Gentet, Valérie, Laurence, Morgane, Cleirec, Ludovic, Mansuy, Emmanuelle, Bompas, Marie-Pierre, Castex, Sophie, Taque, Bruno, Filhon, Marie-Dominique, Tabone, Cécile, Verité, Natacha, Entz-Werle, Laure, Saumet, Gregory, Guimard, Morgane, Pondrom, Christine, Chevreau, Jennifer, Flandrin, Lise, Duranteau, Christine, Rousset-Jablonski, Laurence, Brugières, Marta, Jimenez, Marie-Cécile, Le Deley, Nathalie, Gaspar, Brice, Fresneau, Institut Gustave Roussy (IGR), Centre Léon Bérard [Lyon], Institut d'hématologie et d'oncologie pédiatrique [CHU - HCL] (IHOPe), Hospices Civils de Lyon (HCL), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Institut Curie [Paris], Institut Bergonié [Bordeaux], UNICANCER, Hôpital de la Timone [CHU - APHM] (TIMONE), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), CRLCC René Gauducheau, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Pontchaillou [Rennes], CHU Rouen, Normandie Université (NU), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU), Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, CHU Strasbourg, Hôpital Arnaud de Villeneuve [CHRU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Universitaire de Reims (CHU Reims), Centre Hospitalier Universitaire de Nice (CHU Nice), Institut Claudius Regaud, Unité de Biostatistiques [Toulouse] ( Institut Claudius Regaud / IUCT-O), Institut Claudius Regaud-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Bicêtre, Research on Healthcare Performance (RESHAPE - Inserm U1290 - UCBL1), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Institut Gustave-Roussy, Centre Léon Bérard, CLB, Thanks to the investigators of the following French centers which contributed patients to our study: Centre Léon Bérard, medical oncology, Lyon, CHU St Etienne, CHU Clermont Ferrand, CHU Amiens, Regional Cancer Center, Nancy, Regional Cancer Center, Caen, CHU Besançon, Institut Gustave-Roussy, medical oncology, Villejuif, CHU Tours, CHU Marseille, CHU Grenoble, Regional Cancer Center, Dijon, Regional Cancer Center, Clermont Ferrand, Lenval Hospital, Nice, Regional Cancer Center, Angers, and CHU Rouen.
Subjects: cyclophosphamide/adverse effects, child, Ewing/drug therapy, antineoplastic combined chemotherapy protocols/adverse effects, [SDV.CAN]Life Sciences [q-bio]/Cancer, Ifosfamide/adverse effects
Abstract: International audience; In Euro-EWING99-R1 randomized trial, cyclophosphamide was shown to be noninferior to ifosfamide in the consolidation of standard-risk Ewing sarcoma (SR-EWS) after a common induction with VIDE (vincristine-ifosfamide-doxorubicin-etoposide). We present the results of the late effects analysis of VAC (vincristine-dactinomycin-cyclophoshamide) vs VAI (vincristine-dactinomycin-ifosfamide) conducted in Euro-EWING99-R1 French cohort. Of 267 French randomized patients, 204 were alive and free-of-relapse at 5-years including 172 with available long-term follow-up data concerning cardiac, renal and/or gonadal functions (sex-ratio M/F = 1.3, median age at diagnosis = 14 years): 84 randomized in VAC (median cumulative doses: cyclophosphamide = 9.7 g/m2, ifosfamide = 59.4 g/m2) and 88 in VAI (ifosfamide = 97.1 g/m2). With a median follow-up of 10 years (range = 5-17), five late relapses and five second malignancies were recorded. The 10-year event-free survival among 5-year free-of-relapse survivors was similar between VAC and VAI (93% vs 95%, P =.63). We estimated the 10-year cumulative probabilities of cardiac and kidney toxicities at 4.4% (95% confidence interval [95% CI] = 1.1%-7.6%) and 34.8% (95% CI = 26.8%-42.0%), respectively. Cardiac toxicity cumulative probability was similar in both arms, whereas kidney toxicity was higher in VAI (at 10 years, 43.0% vs 25.7%, P =.02), resulting from significant difference in glomerular toxicity (31.1% vs 13.1%, P
Published: 2023

29. Pain in desmoid-type fibromatosis: Prevalence, determinants and prognosis value

Author: Nicolas Penel, Sylvie Bonvalot, Marie‐Cécile Le Deley, Antoine Italiano, Camille Tlemsani, Diane Pannier, Clémence Leguillette, Jean‐Emmanuel Kurtz, Maud Toulmonde, Julien Thery, Daniel Orbach, Pascale Dubray‐Longeras, Benjamin Verret, François Bertucci, Cécile Guillemet, Lucie Laroche, Armelle Dufresne, Jean‐Yves Blay, Axel Le Cesne, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, CHU Lille, Evaluation des technologies de santé et des pratiques médicales - ULR 2694 (METRICS), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut Curie [Paris], Université Paris sciences et lettres (PSL), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Institut Bergonié [Bordeaux], UNICANCER, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Cité (UPCité), CHU Strasbourg, Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), Institut Gustave Roussy (IGR), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Centre Léon Bérard [Lyon], Ligue Contre le Cancer: PRE2016.LCC/NP, Institut National Du Cancer, INCa, The authors would like to thank the patients and families for their participation in this study, the staff members involved in the trial management and data analysis, in particular Emilie Decoupigny André Michel Bimbaï and Marie Vanseymortier from the sponsorship unit at Centre Oscar Lambret, Lille, all the investigators and their teams who participated in the trial, the patient advocacy group 'SOS Desmoïde,' Françoise Bonichon for her help in literature research and the data managers from Centre de Traitement des Données du Cancéropôle Nord-Ouest (CTD-CNO), who oversaw the trial data management, the CTD-CNO clinical research platform was funded by the French National Cancer Institute (INCa) and 'La Ligue Nationale Contre le Cancer'., This work was supported by a personal grant from a donor (S. Wisnia), the Ligue Nationale Contre le Cancer (PRE2016.LCC/NP), Intersarc (funded by the French National Cancer Institute, INCA), APICIL Foundation and SOS Desmoïde. These funders had no role in the design, conduct or reporting of this work., The authors would like to thank the patients and families for their participation in this study, the staff members involved in the trial management and data analysis, in particular Emilie Decoupigny André Michel Bimbaï and Marie Vanseymortier from the sponsorship unit at Centre Oscar Lambret, Lille, all the investigators and their teams who participated in the trial, the patient advocacy group 'SOS Desmoïde,' Françoise Bonichon for her help in literature research and the data managers from Centre de Traitement des Données du Cancéropôle Nord‐Ouest (CTD‐CNO), who oversaw the trial data management, and the CTD‐CNO clinical research platform was funded by the French National Cancer Institute (INCa) and 'La Ligue Nationale Contre le Cancer'.
Subjects: Cancer Research, Oncology, quality of life, depression, outcome, pain, [SDV.CAN]Life Sciences [q-bio]/Cancer, Desmoid-type fibromatosis
Abstract: International audience; The aim of this study is to evaluate the prevalence, determinants and prognostic value of pain at diagnosis in patients with desmoid-type fibromatosis (DF). We selected patients from the ALTITUDES cohort (NCT02867033), managed by surgery, active surveillance or systemic treatments, with pain assessment at diagnosis. Patients were invited to fill QLQ-C30 questionnaire and Hospital Anxiety Depression Scale. Determinants were identified using logistic models. Prognostic value on event-free survival (EFS) was evaluated using the Cox model. Overall, 382 patients were included in the current study (median age: 40.2 years; 117 men). The prevalence of pain was 36%, without significant difference according to first-line treatment (P =.18). In the multivariate analysis, pain was significantly associated with tumor size >50 mm (P =.013) and tumor site (P
Published: 2023

30. The subjective experience of young women with non-metastatic breast cancer: the Young Women with Breast Cancer Inventory

Author: Anne Congard, Pascal Antoine, A. Lesur, Laurence Vanlemmens, Véronique Christophe, Emmanuelle Fournier, Christelle Duprez, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Laboratoire Sciences Cognitives et Sciences Affectives - UMR 9193 (SCALab), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Centre de Recherche en Psychologie de la Connaissance, du Langage et de l'Émotion (PsyCLÉ), Aix Marseille Université (AMU), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, Département de Sénologie, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER, Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Sciences Cognitives et Sciences Affectives (SCALab) - UMR 9193 (SCALab), and Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER
Subjects: Psychometrics, [SDV]Life Sciences [q-bio], Subjective experience, NEEDS, RECOMMENDATIONS, 0302 clinical medicine, Breast cancer, Quality of life, QUALITY-OF-LIFE, Surveys and Questionnaires, Activities of Daily Living, Adaptation, Psychological, 030212 general & internal medicine, Young adult, PSYCHOLOGICAL DISTRESS, SURVIVORS, General Medicine, 3. Good health, 030220 oncology & carcinogenesis, Female, Psychology, Attitude to Health, Clinical psychology, Adult, PARTNERS, Sexual Behavior, Concurrent validity, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, ADJUSTMENT, PATIENT, Negative affectivity, 03 medical and health sciences, Young Adult, Cronbach's alpha, medicine, Body Image, Humans, Research, Public Health, Environmental and Occupational Health, Cancer, Reproducibility of Results, medicine.disease, ONCOLOGY, QUESTIONNAIRES, Health psychology, Socioeconomic Factors, Self Report, Young women
Abstract: International audience; Background: The subjective experience of young women with breast cancer has some particular features linked to the impact of the disease and its treatment on their age-related issues (e.g. desire for a child, couple relationship, career management). Despite these specific concerns, no questionnaire currently targets the young breast cancer patient's quality of life, subjective experience or common problems when facing cancer. This study presents the psychometric validation of an inventory that aimed to measure the impact of breast cancer on the quality of life of young women (
Published: 2015

31. Necrosis- and apoptosis-related Met cleavages have divergent functional consequences

Author: R, Montagne, M, Berbon, L, Doublet, N, Debreuck, A, Baranzelli, H, Drobecq, C, Leroy, N, Delhem, H, Porte, M-C, Copin, E, Dansin, A, Furlan, D, Tulasne, Site de Recherche Intégrée en Cancérologie (SIRIC-ONCOLille), Université de Lille, Sciences et Technologies-Université de Lille, Sciences Humaines et Sociales-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut de biologie de Lille - IBL (IBLI), Université de Lille, Sciences et Technologies-Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Centre National de la Recherche Scientifique (CNRS)-Université de Lille, Droit et Santé, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institut de Pathologie [CHU Lille], Pôle de Biologie Pathologie Génétique [CHU Lille], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), This work was supported by the CNRS, the Pasteur Institute of Lille, and INSERM, and by grants from the Ligue Contre le Cancer, Comité Nord, the Association pour la Recherche sur le Cancer, the Institut National du Cancer, the Cancéropôle Nord-Ouest, the Site de Recherche Intégrée sur le Cancer, SIRIC ONCOLille, and the Roche company., We thank the Microscopy Imaging Cytometry Facility of the BioImaging Center Lille Nord-de-France for access to instruments and technical advice, and the Chemistry Systems Biology facility for its technical advice and support., Université de Lille-UNICANCER-Université de Lille-UNICANCER-Cancéropole Nord-Ouest-Université de Lille, Droit et Santé-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Université de Lille, Droit et Santé-Centre National de la Recherche Scientifique (CNRS), and Université de Lille-UNICANCER
Subjects: MESH: Signal Transduction, MESH: Calpain/metabolism, Lung Neoplasms, [SDV]Life Sciences [q-bio], MESH: Ionomycin/pharmacology, Apoptosis, Mice, MESH: Apoptosis/physiology, Cell Movement, MESH: RNA, Small Interfering, MESH: Animals, Neoplasm Metastasis, RNA, Small Interfering, MESH: Cell Movement, MESH: Lung Neoplasms/pathology, MESH: Neoplasm Metastasis/pathology, Calpain, Hepatocyte Growth Factor, Ionomycin, MESH: Calcium/metabolism, Proto-Oncogene Proteins c-met, MESH: Epithelial Cells/metabolism, MESH: Cell Survival, Caspases, MESH: HEK293 Cells, RNA Interference, Original Article, MESH: Caspases/metabolism, Signal Transduction, MESH: Enzyme Activation, MESH: Apoptosis/drug effects, MESH: Proto-Oncogene Proteins c-met/metabolism, MESH: Cell Line, Tumor, Cell Survival, MESH: RNA Interference, MESH: Necrosis/pathology, [SDV.BC]Life Sciences [q-bio]/Cellular Biology, Necrosis, Cell Line, Tumor, MESH: Cell Proliferation, Animals, Humans, MESH: Mice, Cell Proliferation, MESH: Humans, MESH: Hepatocyte Growth Factor/metabolism, Epithelial Cells, MESH: ADAM Proteins/metabolism, Enzyme Activation, ADAM Proteins, HEK293 Cells, Calcium
Abstract: International audience; Upon activation by its ligand hepatocyte growth factor/scatter factor, the receptor tyrosine kinase Met promotes survival, proliferation, and migration of epithelial cells during embryogenesis. Deregulated Met signaling can also promote cancer progression and metastasis. Met belongs to the functional family of dependence receptors whose activity switches from pro-survival to pro-apoptotic during apoptosis upon caspase cleavage. Although apoptosis resistance is a hallmark of cancer cells, some remain sensitive to other cell death processes, including necrosis induced by calcium stress. The role and fate of Met during necrotic cell death are unknown. Following treatment with calcium ionophores, cell lines and primary cells undergo necrosis, and the full-length Met receptor is efficiently degraded. This degradation is achieved by double cleavage of Met in its extracellular domain by a metalloprotease of the A disintegrin and metalloproteinase (ADAM) family and in its intracellular domain by calpains (calcium-dependent proteases). These cleavages separate the Met extracellular region from its kinase domain, thus preventing Met activity and its potential pro-survival activity. Although the intracellular fragment is very similar to the fragment generated by caspases, it displays no pro-apoptotic property, likely because of the presence of the last few amino acids of Met, known to inhibit this pro-apoptotic function. The fragments identified here are observed in lung tumors overexpressing the Met receptor, along with fragments previously identified, suggesting that proteolytic cleavages of Met are involved in its degradation in tumor tissues. Thus, Met is a modulator of necrosis, able to protect cells when activated by its ligand but efficiently degraded by proteolysis when this process is engaged.
Published: 2015

32. Luminescence et OSL dans une préforme de silice sol-gel dopée Cu+ sous différentes conditions d’irradiation

Author: Capoen, Bruno, El Hamzaoui, Hicham, Bouwmans, Géraud, Ouerdane, Youcef, Boukenter, Aziz, Girard, Sylvain, Marcandella, Claude, Olivier, Duhamel, Crop, Frederik, Sarrazin, Thierry, Bouazaoui, Mohamed, Laboratoire de Physique des Lasers, Atomes et Molécules - UMR 8523 (PhLAM), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Laboratoire Hubert Curien (LHC), Institut d'Optique Graduate School (IOGS)-Université Jean Monnet - Saint-Étienne (UJM)-Centre National de la Recherche Scientifique (CNRS), DAM Île-de-France (DAM/DIF), Direction des Applications Militaires (DAM), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Physique médicale, Service de radiothérapie / curiethérapie, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER, Capoen, Bruno, Laboratoire Hubert Curien [Saint Etienne] (LHC), Institut d'Optique Graduate School (IOGS)-Université Jean Monnet [Saint-Étienne] (UJM)-Centre National de la Recherche Scientifique (CNRS), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), and Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER
Subjects: [PHYS.PHYS.PHYS-OPTICS] Physics [physics]/Physics [physics]/Optics [physics.optics], [PHYS.PHYS.PHYS-OPTICS]Physics [physics]/Physics [physics]/Optics [physics.optics], ComputingMilieux_MISCELLANEOUS
Abstract: National audience
Published: 2014

33. Change in the value of work after breast cancer: evidence from a prospective cohort

Author: Elsa Caumette, Antonio Di Meglio, Inès Vaz-Luis, Cécile Charles, Julie Havas, Garazi Ruiz de Azua, Elise Martin, Laurence Vanlemmens, Suzette Delaloge, Sibille Everhard, Anne-Laure Martin, Asma Dhaini Merimeche, Olivier Rigal, Charles Coutant, Marion Fournier, Christelle Jouannaud, Patrick Soulie, Paul-Henri Cottu, Olivier Tredan, Gwenn Menvielle, Agnès Dumas, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Université de Montpellier (UM), Institut Gustave Roussy (IGR), Prédicteurs moléculaires et nouvelles cibles en oncologie (PMNCO), Institut Gustave Roussy (IGR)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Département de médecine oncologique [Gustave Roussy], Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, UNICANCER, Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), Institut Curie [Paris], Centre Léon Bérard [Lyon], Epidémiologie Clinique et Evaluation Economique Appliquées aux Populations Vulnérables (ECEVE (U1123 / UMR_S_1123)), Institut National de la Santé et de la Recherche Médicale (INSERM)-AP-HP Hôpital universitaire Robert-Debré [Paris], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité)
Subjects: Oncology, Oncology (nursing), [SDV]Life Sciences [q-bio]
Abstract: Return to work (RTW) after cancer can be modulated by psychosocial factors, including a reordering of one's life values, with more emphasis on private life than work-life. This change in patients' outlook on work-life is however poorly understood.We used data from a French cohort (CANTO, NCT01993498) of women diagnosed with stage I-III primary breast cancer (BC) prospectively assessing life priorities between work and private life at diagnosis and 2 years after diagnosis. We identified women who reported a shift in life values toward private life, and we investigated the clinical, demographic, work-related, and psychosocial determinants of this change using logistic regressions.Overall, 46% (N = 1097) of the women had reordered their life priorities toward private life 2 years after diagnosis. The factors positively associated with this shift included being diagnosed with stage III BC, perceiving one's job as not very interesting, being an employee/clerk (vs. executive occupation), perceiving no support from the supervisor at baseline, perceiving negative interferences of cancer in daily life, and perceiving a positive impact from experiencing cancer. Depressive symptoms were negatively associated with this shift.After BC, there seems to be an important reordering of life values, with more emphasis on private life. This change is influenced by clinical determinants, but also by work-related and psychosocial factors.Stakeholders should consider this change in a patient's outlook on work-life as much as the classical physical late effects when designing post-BC programs to support RTW.
Published: 2022

34. La phase socle en oncologie : retour d’expérience sur les trois premières années d’application de la réforme du troisième cycle

Author: Pierre-Yves Cren, Julie Chartier, Nicolas Penel, Florence Huguet, Jean-Philippe Spano, Luc Ollivier, Matthieu Delaye, Anthony Turpin, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Institut Universitaire de Cancérologie [Sorbonne Université] (IUC), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, and Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)
Subjects: Cancer Research, Oncology, [SDV]Life Sciences [q-bio], Radiology, Nuclear Medicine and imaging, Hematology, General Medicine
Published: 2022

35. Treatment strategies for thymic carcinoma in a real-life setting. Insights from the RYTHMIC network

Author: Arthur Petat, Eric Dansin, Fabien Calcagno, Laurent Greillier, Eric Pichon, Mallorie Kerjouan, Christelle Clement-Duchene, Bertrand Mennecier, Virginie Westeel, François Thillays, Xavier Quantin, Youssef Oulkhouir, Luc Thiberville, Charles Ricordel, Vincent Thomas De Montpreville, Lara Chalabreysse, Véronique Hofman, Thierry Molina, Pierre Fournel, Laurence Bigay Game, Benjamin Besse, Nicolas Girard, Hospices Civils de Lyon (HCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Service d'Oncologie Médicale [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service d'oncologie multidisciplinaire innovations thérapeutiques [Hôpital Nord - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital Nord [CHU - APHM], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Pontchaillou [Rennes], Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, CHU Strasbourg, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Rouen, Normandie Université (NU), Centre Chirurgical Marie Lannelongue (CCML), Hôpital Pasteur [Nice] (CHU), Département de Pathologie [CHU Necker], Université Sorbonne Paris Cité (USPC)-CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), Institut de Cancérologie de la Loire Lucien Neuwirth, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), and Institut Curie [Paris]
Subjects: Cancer Research, Thymoma, Radiotherapy, [SDV.CAN]Life Sciences [q-bio]/Cancer, Thymus Neoplasms, Guidelines, Cohort Studies, Thymic carcinoma, Oncology, Humans, Chemotherapy, Surgery, Neoplasms, Glandular and Epithelial, Prospective Studies, Neoplasm Staging, Retrospective Studies
Abstract: Thymic carcinomas are aggressive and difficult to treat a subset of thymic epithelial tumours that represent a heterogeneous group of rare intrathoracic malignancies. The treatment strategy of thymic carcinomas is based on whether surgical resection may be achieved, which represents the most significant favourable prognostic factor on survival. For this study, we took advantage of the unique prospective Réseau tumeurs THYMiques et Cancer (RYTHMIC) database to describe baseline characteristics, analyse treatment strategies in light of existing guidelines and provide landmark patient outcomes data with regards to response and survival of patients in a real-life clinical practice setting.Inclusion criteria for this analysis were the following: (1) histologically-confirmed thymic carcinomas - excluding neuroendocrine tumours-after pathological review by the RYTHMIC pathology panel, (2) discussion of the case at the RYTHMIC multidisciplinary tumour board, (3) at least one active treatment modality.A total of 213 patients were analysed. Overall, 60 (28%) patients were considered as surgical candidates upfront, 91 (43%) patients received primary chemotherapy, and 62 (29%) patients received exclusive chemotherapy. Median overall survival (OS) was 49.2 months (IC95%: 34.8-63.6); OS was significantly longer in patients with a lower stage at diagnosis (p 0.001), who were operated on upfront, as opposed to patients who received primary or exclusive chemotherapy (p 0.001). Surgery, conducted upfront or after primary chemotherapy, was significantly associated with more prolonged OS (p 0.001); complete resection and postoperative radiotherapy were also predictors of better outcome (p = 0.018 and p = 0.051, respectively).Our cohort is the first to analyse in-depth outcomes and treatment strategies in a prospective cohort of consecutive patients with thymic carcinoma. While we confirm the major prognostic impact of surgery, our data highlight the need for optimised multidisciplinary management and innovative therapies as the survival of patients remains limited.
Published: 2022

36. Long-term oncological safety of sentinel lymph node biopsy in early-stage cervical cancer: A post-hoc analysis of SENTICOL I and SENTICOL II cohorts

Author: Jean Lévêque, Virginie Fourchotte, Laurent Magaud, Eric Leblanc, Marc Baron, Philippe Morice, Benedetta Guani, Denis Querleu, Patrice Mathevet, Emile Daraï, Vincent Balaya, Henri Marret, Fabrice Lecuru, INSERM, Université de Lille, Protéomique, Réponse Inflammatoire, Spectrométrie de Masse (PRISM) - U1192, Centre Hospitalier Universitaire Vaudois [Lausanne] [CHUV], Institut Gustave Roussy [IGR], CHU Strasbourg, Institut Curie [Paris], CHU Tenon [AP-HP], Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen [CLCC Henri Becquerel], Hôpital Bretonneau, Centre Hospitalier Universitaire [Rennes], Centre Hospitalier Lyon Sud [CHU - HCL] [CHLS], Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Institut Gustave Roussy (IGR), Département de chirurgie gynécologique [Gustave Roussy], Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), CHU Pontchaillou [Rennes], and Hospices Civils de Lyon (HCL)
Subjects: Adult, medicine.medical_specialty, Multivariate analysis, SENTICOL, Sentinel lymph node, Urology, Uterine Cervical Neoplasms, Oncologic outcomes, Disease-Free Survival, Cohort Studies, Young Adult, Risk Factors, Post-hoc analysis, Biopsy, medicine, Humans, Prospective Studies, Stage (cooking), Pelvic lymphadenectomy, Aged, Neoplasm Staging, Proportional Hazards Models, Aged, 80 and over, Cervical cancer, Risk level, medicine.diagnostic_test, Sentinel Lymph Node Biopsy, business.industry, Obstetrics and Gynecology, Middle Aged, medicine.disease, Oncology, Female, Disease-free survival, France, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; Objectives: To compare oncologic outcomes of patients with early-stage cervical cancer and negative nodes who underwent sentinel lymph node biopsy alone (SLNB) versus pelvic lymphadenectomy (PL).Methods: An ancillary analysis of two prospective multicentric trials on SLN biopsy for cervical cancer (SENTICOL I and II) was conducted. Only patients with early-stage cervical cancer (IA to IIA FIGO stage), bilateral detection of SLN, negative SLN after ultrastaging and negative non-SLN after final pathologic examination were included. Risk-factors of recurrence and disease-specific mortality were determined by Cox proportional hazard models.Results: Between January 2005 and July 2012, 259 node-negative patients were analyzed: 87 in the SLNB group and 172 in the PL group. The median follow-up was 47 months [4-127]. During the follow-up, 21 patients (8.1%) experienced recurrences, including 4 nodal recurrences (1.9%), and 9 patients (3.5%) died of cervical cancer. Disease-free survival (DFS) and disease-specific survival (DSS) were similar between SLNB and PL groups, 85.1% vs. 80.4%, p = 0.24 and 90.8% vs. 97.2%, p = 0.22 respectively. By Cox multivariate analysis, SLNB compared to PL was not associated with DFS (HR = 1.78, 95%CI = [0.71-4.46], p = 0.22) neither with DSS (HR = 3.02, 95%CI = [0.69-13.18], p = 0.14). Only pathologic risk level according to the Sedlis criteria was an independent predictor of DFS and DSS.Conclusions: Omitting full pelvic lymphadenectomy for patients with bilateral negative SLN does not seem to be associated with an increased risk of recurrence in this series. Survival non-inferiority needs to be confirmed by prospective trials.
Published: 2022

37. Pharmacokinetics of oral vinorelbine in French children with recurrent or progressive primary low‐grade glioma

Author: Alicia Probst, Emilie De Carli, Isabelle Aerts, Pascal Chastagner, Natacha Entz-Werle, Caroline Solas, Anne-Isabelle Bertozzi-Salamon, Nicolas André, Anne Pagnier, Emmanuelle Tresch-Bruneel, Pierre Leblond, Jacques Grill, Didier Frappaz, Mourad Hamimed, Florence Gattacceca, Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Simulation and Modeling of Adaptive Response for Therapeutics in Cancer (SMARTc), Centre de Recherche en Cancérologie de Marseille (CRCM), Pédiatrie et oncologie pédiatrique [Hôpital de la Timone - APHM], Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre Hospitalier Universitaire de Nancy (CHU Nancy), Centre Hospitalier Universitaire [Grenoble] (CHU), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Laboratoire de Bioimagerie et Pathologies (LBP), Université de Strasbourg (UNISTRA)-Centre National de la Recherche Scientifique (CNRS), CHU Strasbourg, Vectorologie et thérapeutiques anti-cancéreuses [Villejuif] (UMR 8203), Université Paris-Sud - Paris 11 (UP11)-Institut Gustave Roussy (IGR)-Centre National de la Recherche Scientifique (CNRS), Département de cancérologie de l'enfant et de l'adolescent [Gustave Roussy], Institut Gustave Roussy (IGR), Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology (MCMCC), Centre Léon Bérard [Lyon], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Unité des Virus émergents [Marseille] (UVE - Faculté de Médecine), Université de la Méditerranée - Aix-Marseille 2-Faculté de Médecine [Marseille], Université de la Méditerranée - Aix-Marseille 2, and Hôpital de la Timone [CHU - APHM] (TIMONE)
Subjects: medicine.medical_specialty, Adolescent, Phases of clinical research, Vinorelbine, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, Bayesian multivariate linear regression, Glioma, Internal medicine, Humans, Medicine, Pharmacology (medical), Child, Infusions, Intravenous, ComputingMilieux_MISCELLANEOUS, 030304 developmental biology, Pharmacology, Body surface area, Volume of distribution, 0303 health sciences, business.industry, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, medicine.disease, 3. Good health, 030220 oncology & carcinogenesis, Low-Grade Glioma, Neoplasm Recurrence, Local, business, Half-Life, medicine.drug
Abstract: AIM There is a crucial need for pharmacokinetic (PK) data of oral vinorelbine (VNR) in pediatric population. The aim of this work was to assess the PK profile of orally administered VNR in children with recurrent/progressive primary low-grade glioma (LGG). METHODS A multicentric, open-label, single-arm intervention phase II study was conducted. Patients, aged between 6 and 18 years, with histologically confirmed recurrent or progressive primary LGG or non-documented typical optic pathway tumors, were included. PK parameters were estimated by non-compartmental analysis using Phoenix WinNonlin® software (version 8.0, Certara, Inc.). The Influence of demographic and biological covariates on VNR PK parameters was investigated using a multivariate linear regression analysis. RESULTS PK analysis included 36 patients with a median age (range) of 11 (6-17) years. Estimates of apparent oral clearance (CL/F), apparent volume of distribution (V/F), half-life (t1/2 ) and their between-subject variability (CV%) at 60 mg.m-2 dose level, were 472 L.h-1 (51.8%), 7002 L (57.9%) and 10 h (21.0%), respectively. Negligible accumulation of VNR between C1 and C2 was observed. CL/F and V/F were found to increase with body surface area (BSA) (p = 0.004). Lower area under the concentration-time curve (AUC) levels were observed among children in comparison to adults. CONCLUSION Higher doses may be necessary for children with LGG. BSA showed a significant impact on VNR systemic exposure. We believe that our findings will serve as a basis for further studies to better characterize the concentration-response relationships of VNR among pediatric patients.
Published: 2021

38. Real-World Data About Treatment Pattern and Outcomes of Patients With Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcinoma in France: Results From the Fregat Database

Author: Piessen, G, Adenis, A, Renaud, F, Devaux, S, Bergeat, D, El Hajbi, F, Regenet, N, Régimbeau, Jean-Marc, Gricar, J, Singh, P, Paul, C, Baklouti, M, Thomas, C, Emery, C, Torreton, E, Fagnani, F, CHU Lille, Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Institut Jean Lamour (IJL), Institut de Chimie du CNRS (INC)-Université de Lorraine (UL)-Centre National de la Recherche Scientifique (CNRS), CHU Pontchaillou [Rennes], Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, CHU Amiens-Picardie, Simplification des soins chez les patients complexes - UR UPJV 7518 (SSPC), Université de Picardie Jules Verne (UPJV), Institut de Recherches sur les lois Fondamentales de l'Univers (IRFU), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Paris-Saclay, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Bristol-Myers Squibb Company, and Centre hospitalier universitaire de Nantes (CHU Nantes)
Subjects: [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract: International audience; Esophageal cancer is the seventh most common cancer and sixth leading cause of cancer death, worldwide, with approximately 600,000 new cases and over 540,000 deaths in 2020. Squamous-cell carcinoma accounts for approximately 60% of cases in Europe. The study aim was to describe real-world treatment and outcomes of French patients presenting with UnResectable Advanced, or Metastatic Esophageal Squamous-Cell Carcinoma (URAM-ESCC) from 2014 to 2019 before approval of immune-checkpoint inhibitors (ICI).
Published: 2022

39. Direct interaction of TrkA/CD44v3 is essential for NGF-promoted aggressiveness of breast cancer cells

Author: Sarah Trouvilliez, Julien Cicero, Romain Lévêque, Léo Aubert, Cyril Corbet, Alexandre Van Outryve, Karolin Streule, Pierre-Olivier Angrand, Pamela Völkel, Romain Magnez, Guillaume Brysbaert, Caroline Mysiorek, Fabien Gosselet, Roland Bourette, Eric Adriaenssens, Xavier Thuru, Chann Lagadec, Jérôme de Ruyck, Véronique Orian-Rousseau, Xuefen Le Bourhis, Robert-Alain Toillon, Université de Lille, CNRS, Cancer Heterogeneity, Plasticity and Resistance to Therapies (CANTHER) - UMR 9020 - UMR 1277, Unité de Glycobiologie Structurale et Fonctionnelle (UGSF) - UMR 8576, Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 [CANTHER], Plasticité Cellulaire et Cancer - U908 (CPAC), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 (CANTHER), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS), Signalisation des facteurs de croissance dans le cancer du sein. Protéomique fonctionnelle, Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Lille, Unité de Glycobiologie Structurale et Fonctionnelle - UMR 8576 (UGSF), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Laboratoire de la Barrière Hémato-Encéphalique (LBHE), Université d'Artois (UA), Institut de biologie de Lille - IBL (IBLI), Université de Lille, Sciences et Technologies-Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Université de Lille, Droit et Santé-Centre National de la Recherche Scientifique (CNRS), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Centre de Recherche Jean-Pierre AUBERT Neurosciences et Cancer - U837 (JPArc), Université Lille Nord de France (COMUE)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, and UCL - SSS/IREC/FATH - Pôle de Pharmacologie et thérapeutique
Subjects: Life sciences, biology, Cancer Research, animal structures, [SDV]Life Sciences [q-bio], Breast Neoplasms, Mice, Hyaluronan Receptors, Oncology, nervous system, ddc:570, Nerve Growth Factor, Animals, Humans, Protein Isoforms, Female, Receptor, trkA
Abstract: Background CD44 is a multifunctional membrane glycoprotein. Through its heparan sulfate chain, CD44 presents growth factors to their receptors. We have shown that CD44 and Tropomyosin kinase A (TrkA) form a complex following nerve growth factor (NGF) induction. Our study aimed to understand how CD44 and TrkA interact and the consequences of inhibiting this interaction regarding the pro-tumoral effect of NGF in breast cancer. Methods After determining which CD44 isoforms (variants) are involved in forming the TrkA/CD44 complex using proximity ligation assays, we investigated the molecular determinants of this interaction. By molecular modeling, we isolated the amino acids involved and confirmed their involvement using mutations. A CD44v3 mimetic peptide was then synthesized to block the TrkA/CD44v3 interaction. The effects of this peptide on the growth, migration and invasion of xenografted triple-negative breast cancer cells were assessed. Finally, we investigated the correlations between the expression of the TrkA/CD44v3 complex in tumors and histo-pronostic parameters. Results We demonstrated that isoform v3 (CD44v3), but not v6, binds to TrkA in response to NGF stimulation. The final 10 amino acids of exon v3 and the TrkA H112 residue are necessary for the association of CD44v3 with TrkA. Functionally, the CD44v3 mimetic peptide impairs not only NGF-induced RhoA activation, clonogenicity, and migration/invasion of breast cancer cells in vitro but also tumor growth and metastasis in a xenograft mouse model. We also detected TrkA/CD44v3 only in cancerous cells, not in normal adjacent tissues. Conclusion Collectively, our results suggest that blocking the CD44v3/TrkA interaction can be a new therapeutic option for triple-negative breast cancers.
Published: 2022

40. The French FRACTURE database: A way to improve knowledge on management of children with very rare tumors

Author: Coralie Mallebranche, Yves Reguerre, Brice Fresneau, Nicolas Andre, Claire Berger, Claire Briandet, Marie‐Pierre Castex, Anne‐Sophie Defachelles, Cécile Faure‐Conter, Julien Lejeune, Sébastien Klein, Guy Leverger, Aude Marie‐Cardine, Caroline Oudot, Claire Freycon, Stéphanie Proust, Marianne Roumy, Estelle Thebaud, Cécile Verite, Brigitte Lacour, Daniel Orbach, Centre de Recherche en Cancérologie et Immunologie Intégrée Nantes-Angers (CRCI2NA ), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Unité d'Immuno-Hémato-Oncologie Pédiatrique [Angers], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Universitaire de La Réunion (CHU La Réunion), Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Hôpital du Bocage, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Service d'hémato-immuno-oncologie pédiatrique [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), ERL 7001 LNOx (Leukemic Niche & redOx metabolism / Niche leucémique et métabolisme redOx) (LNOx), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Centre National de la Recherche Scientifique (CNRS)-Microenvironnement des niches tumorales (CNRS GDR 3697 Micronit ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Groupe innovation et ciblage cellulaire (GICC), EA 7501 [2018-...] (GICC EA 7501), Université de Tours (UT)-Université de Tours (UT), CHU Trousseau [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service d'Oncologie médicale [CHU Limoges], CHU Limoges, Centre Hospitalier Universitaire [Grenoble] (CHU), Service d'Immunologie Hématologie et Oncologie pédiatriques [CHU Angers], Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital Pellegrin Tripode, Equipe 7 : EPICEA - Epidémiologie des cancers de l'enfant et de l'adolescent (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Registre National des Tumeurs Solides de l'Enfant (RNTSE), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), and Institut Curie [Paris]
Subjects: very rare tumors, Adolescent, Databases, Factual, Incidence, [SDV]Life Sciences [q-bio], Hematology, FRACTURE database, national registry, childhood malignancies, Oncology, Neoplasms, Pediatrics, Perinatology and Child Health, Humans, Registries, France, Child
Abstract: International audience; Introduction: Very rare pediatric tumors (VRTs), defined by an annual incidence ≤2 per million inhabitants, represent a heterogeneous group of cancers. Due to their extremely low incidence, knowledge on these tumors is scant. Since 2012, the French Very Rare Tumors Committee (FRACTURE) database has recorded clinical data about VRTs in France. This study aims: (a) to describe the tumors registered in the FRACTURE database; and (b) to compare these data with those registered in the French National Registry of Childhood Cancer (RNCE).Methods: Data recorded in the FRACTURE database between January 1, 2012 and December 31, 2018 were analyzed. In addition, these data were compared with those of the RNCE database between 2012 and 2015 to evaluate the completeness of the documentation and understand any discrepancies.Results: A total of 477 patients with VRTs were registered in the FRACTURE database, representing 97 histological types. Of the 14 most common tumors registered in the RNCE (772 patients), only 19% were also registered in the FRACTURE database. Total 39% of children and adolescent VRTs registered in the RNCE and/or FRACTURE database (323 of a total of 828 patients) were not treated in or linked to a specialized pediatric oncology unit.Conclusion: VRTs represent many different heterogenous entities, which nevertheless account for 10% of all pediatric cancers diagnosed each year. Sustainability in the collection of these rare tumor cases is therefore important, and a regular systematic collaboration between the FRACTURE database and the RNCE register helps to provide a more exhaustive picture of these VRTs and allow research completeness for some peculiar groups of patients.
Published: 2022

41. Extracranial germ cell tumours in children and adolescents: Results from the French TGM13 protocol

Author: Cecile Faure‐Conter, Daniel Orbach, Hélène Sudour‐Bonnange, Cecile Verité, Ludovic Mansuy, Angelique Rome, Cecile Dumesnil, Estelle Thebaud, Marleen Renard, Frederic Hameury, Aude Flechon, Ellen Blanc, Frederique Dijoud, Brice Fresneau, Sylvie Chabaud, Institut d'hématologie et d'oncologie pédiatrique [CHU - HCL] (IHOPe), Hospices Civils de Lyon (HCL), Institut Curie [Paris], Université Paris sciences et lettres (PSL), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Hôpital Pellegrin, CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service de pédiatrie, d'hématologie et d'oncologie [Hôpital de La Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), CHU Rouen, Normandie Université (NU), Centre hospitalier universitaire de Nantes (CHU Nantes), University Hospitals Leuven [Leuven], Hôpital Femme Mère Enfant [CHU - HCL] (HFME), Centre Léon Bérard [Lyon], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Institut Gustave Roussy (IGR), Enfance et Santé, French paediatrics and adolescents cancer society, and Société Française de lutte contre les Cancers et les leucémies de l'Enfant et de l'Adolescent, SFCE
Subjects: Oncology, children, [SDV]Life Sciences [q-bio], Pediatrics, Perinatology and Child Health, germ cell tumours, Hematology, chemotherapy, tumour marker decline
Abstract: International audience; Background: Chemotherapy for non-seminomatous germ cell tumours (NSGCT) exposes to dose-dependent toxicities. The TGM13-NS protocol (EudraCT 2013-004039-60) aimed to decrease the chemotherapy burden compared to the previous TGM95 protocol while maintaining the 5-year event-free survival (EFS) at 80% or more. Procedure: Patients less than 19 years of age with disseminated NSGCT were enrolled (May 2014 to May 2019) and stratified into four groups: two intermediate-risk (IR: localised tumour with low tumour markers [TM]) groups treated with VBP (vinblastine–bleomycin–cisplatin): three courses for IR1 (ovarian tumour any age/testis tumour less than or equal to 10 years) and four courses for IR2 (extragonadal tumour 10 years or less) groups, and two high-risk (HR: metastatic and/or high TM) groups treated with etoposide–cisplatin and either ifosfamide (VIP) or bleomycin (BEP): three courses for HR1 (ovarian tumour any age/testis tumour less than or equal to 10 years and low TM/testis tumour more than 10 years and very low TM) groups and four courses for HR2 (remainder) groups. Results: One hundred fifteen patients were included: median age of 12.8 years (0.4–18.9); tumour sites: 44 ovaries, 37 testes and 34 extragonadal. The 5-year EFS and overall survival (OS) were 87% (95% CI: 80–92) and 95% (89–98), respectively (median follow-up: 3.5 years, range: 0.2–5.9), similar to those of the TGM95 protocol (5-year EFS 89% (84–93), 5-year OS 93% (89–95), p =.561). The 5-year EFS were 93% (95% CI: 80–98), 88% (71–95) and 79% (62–90) for ovarian, testicular and extragonadal tumours, respectively. The 5-year EFS varied (p =.02) according to the risk groups: 90% (66–97), 64% (30–85), 95% (72–99) and 87% (74–94) for IR1, IR2, HR1 and HR2, respectively. TM decline adjusted to tumour site, and alpha-fetoprotein (AFP) level revealed a prognostic impact of time to normalisation on EFS: HR = 1.03 (1.003–1.007). Conclusion: Risk-adapted and globally decreased chemotherapy burden maintains excellent outcomes, exclusive of the IR2 group, which warrants more intensive chemotherapy.
Published: 2022

42. Everolimus Added to Adjuvant Endocrine Therapy in Patients With High-Risk Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Primary Breast Cancer

Author: Thomas Bachelot, Paul Cottu, Sylvie Chabaud, Florence Dalenc, Djelila Allouache, Suzette Delaloge, Jean-Philippe Jacquin, Julien Grenier, Laurence Venat Bouvet, Apurna Jegannathen, Mario Campone, Francesco Del Piano, Marc Debled, Anne-Claire Hardy-Bessard, Sylvie Giacchetti, Marie-Ange Mouret-Reynier, Philippe Barthelemy, Laure Kaluzinski, Audrey Mailliez, Eric Legouffe, Matthew Sephton, Judith Bliss, Jean-Luc Canon, Frederique Penault-Llorca, Jerome Lemonnier, David Cameron, Fabrice Andre, Rhodia Opérations, RHODIA, Imagerie Moléculaire et Stratégies Théranostiques (IMoST), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne [2017-2020] (UCA [2017-2020]), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Centre Léon Bérard [Lyon], Department of Medical Oncology, Institut Curie, Paris 75248, France, Institut Claudius Regaud, Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Service Oncologie Médicale [Saint Priest en Jarez], Institut de Cancérologie Lucien Neuwirth [Saint Priest en Jarez], Laboratoire de Biologie du Développement (LBD), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut de Biologie Paris Seine (IBPS), Université Pierre et Marie Curie - Paris 6 (UPMC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre National de la Recherche Scientifique (CNRS), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), Institut Bergonié [Bordeaux], Centre Armoricain de Radiothérapie, d'Imagerie médicale et d'Oncologie [Plérin, Saint-Brieuc] (CARIO), Hôpital Saint-Louis, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), ChemBioPharm, Université de Bordeaux (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Service d'hématologie et oncologie médicale, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie-Université de Montpellier (UM), Qingdao Agricultural University Qingdao, Institut Armand Frappier (INRS-IAF), Institut National de la Recherche Scientifique [Québec] (INRS)-Réseau International des Instituts Pasteur (RIIP), Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Hôtel-Dieu de Nantes-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Laennec-Centre National de la Recherche Scientifique (CNRS)-Faculté de Médecine d'Angers-Centre hospitalier universitaire de Nantes (CHU Nantes), CRLCC Paul Papin, Université Catholique de Louvain = Catholic University of Louvain (UCL), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), Maladies chroniques, santé perçue, et processus d'adaptation (APEMAC), Université Paris Descartes - Paris 5 (UPD5)-Université de Lorraine (UL), École des Hautes Études en Santé Publique [EHESP] (EHESP), Laboratoire d'Ergonomie et d'Épidémiologie en Santé au Travail (LEEST), Université d'Angers (UA)-Centre Hospitalier Universitaire d'Angers (CHU Angers), and PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Institut de Veille Sanitaire (INVS)
Subjects: Cancer Research, MESH: Xenograft Model Antitumor Assays, Receptor, ErbB-2, [SDV]Life Sciences [q-bio], H3K27me3, JMJD3, Breast Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH: Everolimus, Disease-Free Survival, AR status, GSK-J4, Double-Blind Method, Antineoplastic Combined Chemotherapy Protocols, Humans, asymptomatic, MESH: Double-Blind Method, Everolimus, epidrugs, COVID, Prostate cancer, MESH: Humans, epigenetics, Cancer patients, MESH: Receptor, ErbB-2, MESH: Antineoplastic Combined Chemotherapy Protocols, xenografts, Oncology, Chemotherapy, Adjuvant, MESH: Chemotherapy, Adjuvant, MESH: Pyrimidines, MESH: Disease-Free Survival, Female, MESH: Female, MESH: Breast Neoplasms
Abstract: PURPOSE Everolimus, an oral inhibitor of the mammalian target of rapamycin, improves progression-free survival in combination with endocrine therapy (ET) in postmenopausal women with aromatase inhibitor–resistant metastatic breast cancer. However, the benefit of adding everolimus to ET in the adjuvant setting in early breast cancer is unknown. PATIENTS AND METHODS In this randomized double-blind phase III study, women with high-risk, hormone receptor–positive, human epidermal growth factor receptor 2–negative primary breast cancer were randomly assigned to everolimus or placebo for 2 years combined with standard ET. Stratification factors included ET agent, receipt of neoadjuvant versus adjuvant chemotherapy, progesterone receptor status, duration of ET before random assignment, and lymph node involvement. The primary end point was disease-free survival (DFS). The trial is registered with ClinicalTrials.gov (identifier: NCT01805271 ). RESULTS Between June 2013 and March 2020, 1,278 patients were randomly allocated to receive everolimus or placebo. At the first interim analysis, the trial was stopped for futility and a full analysis undertaken once data snapshot complete. One hundred forty-seven patients have had a DFS event reported and at 3 years, DFS did not differ between patients who received ET plus everolimus (88% [95% CI, 85 to 91]) or ET plus placebo (89% [95% CI, 86 to 91; hazard ratio, 0.95; 95% CI, 0.69 to 1.32; P = .77]). Grade ≥ 3 adverse events were reported in 22.9% of patients (29.9% with everolimus v 15.9% with placebo, P < .001). 53.4% everolimus-treated patients permanently discontinued experimental treatment early compared with placebo-treated 22.3%. CONCLUSION Among high-risk patients, everolimus added to adjuvant ET did not improve DFS. Tolerability was a concern, with more than half of patients stopping everolimus before study completion. Everolimus cannot be recommended in the adjuvant setting.
Published: 2022

43. Sol-gel derived ionic copper-doped glasses and microstructured optical fibers: a potential radiation dosimeter

Author: Capoen, Bruno, El Hamzaoui, Hicham, Bigot, Laurent, Bouwmans, Géraud, Ouerdane, Youcef, Boukenter, Aziz, Girard, Sylvain, Chadeyron, Geneviève, Mahiou, Rachid, Crop, Frederik, Thierry, Sarrazin, Bouazaoui, Mohamed, Laboratoire de Physique des Lasers, Atomes et Molécules - UMR 8523 (PhLAM), Université de Lille-Centre National de la Recherche Scientifique (CNRS), Laboratoire Hubert Curien (LHC), Institut d'Optique Graduate School (IOGS)-Université Jean Monnet - Saint-Étienne (UJM)-Centre National de la Recherche Scientifique (CNRS), MI, Institut de Chimie de Clermont-Ferrand (ICCF), Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS)-Université Blaise Pascal - Clermont-Ferrand 2 (UBP)-SIGMA Clermont (SIGMA Clermont)-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Matériaux Inorganiques (MI), Physique médicale, Service de radiothérapie / curiethérapie, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER-Université de Lille-UNICANCER, Laboratoire Hubert Curien [Saint Etienne] (LHC), Institut d'Optique Graduate School (IOGS)-Université Jean Monnet [Saint-Étienne] (UJM)-Centre National de la Recherche Scientifique (CNRS), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER-Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER-Université Lille Nord de France (COMUE)-UNICANCER, and Capoen, Bruno
Subjects: [PHYS.PHYS.PHYS-OPTICS] Physics [physics]/Physics [physics]/Optics [physics.optics], [PHYS.PHYS.PHYS-OPTICS]Physics [physics]/Physics [physics]/Optics [physics.optics], ComputingMilieux_MISCELLANEOUS
Abstract: International audience
Published: 2014

44. Recommendations for planning and delivery of radical radiotherapy for localized urothelial carcinoma of the bladder

Author: Renaud de Crevoisier, David Azria, Christophe Hennequin, Jonathan Khalifa, Pierre Graff-Cailleaud, Igor Latorzeff, Gilles Créhange, Pierre Blanchard, Arnaud Mejean, Nicolas Magné, Morgane Cabaillé, Olivier Riou, Morgan Rouprêt, Géraldine Pignot, S. Belhomme, Olivier Chapet, Paul Sargos, Stéphane Culine, David Pasquier, Stéphane Supiot, Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Endothelium Radiobiology and Targeting (CRCINA-ÉQUIPE 14), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Hopital Saint-Louis [AP-HP] (AP-HP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Gustave Roussy (IGR), Department of Radiotherapy, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Institut de Cancérologie Lucien Neuwirth, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Laboratoire Traitement du Signal et de l'Image (LTSI), Université de Rennes (UR)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Eugène Marquis (CRLCC), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Institut du Cancer de Montpellier (ICM), Institut Bergonié [Bordeaux], UNICANCER, Clinique Pasteur [Toulouse], Equipe IFTIM [ImViA - EA7535], Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER-Imagerie et Vision Artificielle [Dijon] (ImViA), Université de Bourgogne (UB)-Université de Bourgogne (UB), Centre pour l'innovation en cancérologie de Lyon (CICLY), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Hôpital Européen Georges Pompidou [APHP] (HEGP), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)
Subjects: medicine.medical_specialty, [SDV.IB.IMA]Life Sciences [q-bio]/Bioengineering/Imaging, medicine.medical_treatment, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SDV.IB.MN]Life Sciences [q-bio]/Bioengineering/Nuclear medicine, Guidelines, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, Medical physics, Adaptive radiotherapy, Adaptative radiotherapy, Urothelial carcinoma, Image-guided radiation therapy, Carcinoma, Transitional Cell, Bladder cancer, Image guided radiation therapy, Radiotherapy, business.industry, Radiotherapy Planning, Computer-Assisted, Standard treatment, Radiotherapy Dosage, Radical radiotherapy, Hematology, medicine.disease, Clinical trial, Radiation therapy, Urinary Bladder Neoplasms, Oncology, 030220 oncology & carcinogenesis, Radiotherapy, Intensity-Modulated, Trimodal therapy, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Radiotherapy, Image-Guided
Abstract: International audience; Purpose: Curative radio-chemotherapy is recognized as a standard treatment option for muscle-invasive bladder cancer (MIBC). Nevertheless, the technical aspects for MIBC radiotherapy are heterogeneous with a lack of practical recommendations.Methods and materials: In 2018, a workshop identified the need for two cooperative groups to develop consistent, evidence-based guidelines for irradiation technique in the delivery of curative radiotherapy. Two radiation oncologists performed a review of the literature addressing several topics relative to radical bladder radiotherapy: planning computed tomography acquisition, target volume delineation, radiation schedules (total dose and fractionation) and dose delivery (including radiotherapy techniques, image-guided radiotherapy (IGRT) and adaptive treatment modalities). Searches for original and review articles in the PubMed and Google Scholar databases were conducted from January 1990 until March 2020. During a meeting conducted in October 2020, results on 32 topics were presented and discussed with a working group involving 15 radiation oncologists, 3 urologists and one medical oncologist. We applied the American Urological Association guideline development's method to define a consensus strategy.Results: A consensus was obtained for all 34 except 4 items. The group did not obtain an agreement on CT enhancement added value for planning, PTV margins definition for empty bladder and full bladder protocols, and for pelvic lymph-nodes irradiation. High quality evidence was shown in 6 items; 8 items were considered as low quality of evidence.Conclusion: The current recommendations propose a homogenized modality of treatment both for routine clinical practice and for future clinical trials, following the best evidence to date, analyzed with a robust methodology. The XXX group formulates practical guidelines for the implementation of innovative techniques such as adaptive radiotherapy.
Published: 2021

45. Half of Postoperative Deaths After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy Could be Preventable

Author: Catherine Arvieux, Jean-Jacques Tuech, Bertrand Celerier, Etienne Gayat, Olivier Glehen, Naoual Bakrin, Nicolas Pirro, François Quenet, Williams Tessier, Cecilia Ceribelli, Diane Goéré, Brice Paquette, Isabelle Sourrouille, Marc Pocard, Denis Pezet, Cécile Brigand, Jérémie H. Lefevre, Thomas Courvosier-Clement, Abdelkader Taibi, Frédéric Dumont, Olivia Sgarbura, David Moszkowicz, Guillaume Piessen, Koceila Amroun, Pascale Mariani, Clarisse Eveno, Jean-Baptiste Delhorme, Jean-Marc Guilloit, Charles Sabbagh, Constance Houlzé-Laroye, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), UNICANCER - Institut régional du Cancer Montpellier Val d'Aurelle (ICM), CRLCC Val d'Aurelle - Paul Lamarque, Marqueurs cardiovasculaires en situation de stress (MASCOT (UMR_S_942 / U942)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP)-Université Sorbonne Paris Nord, Cardiovascular and Renal Clinical Trialists [Vandoeuvre-les-Nancy] (INI-CRCT), Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu [Nancy], French-Clinical Research Infrastructure Network - F-CRIN [Paris] (Cardiovascular & Renal Clinical Trialists - CRCT ), Department of Anesthesiology & Critical Care, Hôpital Lariboisière, Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de chirurgie digestive [CHU Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Interface de Recherche Fondamentale et Appliquée en Cancérologie (IRFAC - Inserm U1113), Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Paul Strauss : Centre Régional de Lutte contre le Cancer (CRLCC)-Fédération de Médecine Translationelle de Strasbourg (FMTS), Hôpital de Hautepierre [Strasbourg], CHU Strasbourg, Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), Institut Jean Godinot [Reims], Centre Hospitalier Universitaire [Grenoble] (CHU), Maladies et hormones du système nerveux (DHNS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Hôpital de la Timone [CHU - APHM] (TIMONE), Sorbonne Université (SU), Service de Chirurgie Digestive [CHRU Besançon], Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut Curie [Paris], Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte (M2iSH), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre de Recherche en Nutrition Humaine d'Auvergne (CRNH d'Auvergne)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Université Clermont Auvergne (UCA), CHU Amiens-Picardie, Simplification des soins chez les patients complexes - UR UPJV 7518 (SSPC), Université de Picardie Jules Verne (UPJV), Hôpital Claude Huriez [Lille], CHU Lille, Université de Bordeaux (UB), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), CHU Limoges, Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Institut du Cancer de Montpellier (ICM), Service de Chirurgie Digestive, Hépato-Bilio-pancréatique et Transplantation Hépatique [CHU Pitié-Salpétrière], CHU Pitié-Salpêtrière [AP-HP], CArcinose Péritoine Paris-Technologies (ex-CART) (CAP Paris-Tech (UMR_S_1275)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Institut Gustave Roussy (IGR), Département de chirurgie viscérale [Gustave Roussy], Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre pour l'innovation en cancérologie de Lyon (CICLY), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, Service d'Anesthésie-Réanimation [AP-HP Hôpitaux Saint-Louis Lariboisière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Lariboisière-Fernand-Widal [APHP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Cité (UPCité), Hôpital Robert Debré, Hôpital Robert Debré-Centre Hospitalier Universitaire de Reims (CHU Reims), Hôpital Louis Mourier - AP-HP [Colombes], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Service de Chirurgie Digestive et Hépatobiliaire [CHU Clermont-Ferrand], CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Hopital Saint-Louis [AP-HP] (AP-HP), Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 (CANTHER), Institut Pasteur de Lille, and Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Male, medicine.medical_specialty, [SDV]Life Sciences [q-bio], Postoperative death, [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, Hyperthermic Intraperitoneal Chemotherapy, cytoreductive surgery, Humans, Medicine, Postoperative Period, Peritoneal Neoplasms, Aged, Retrospective Studies, Cause of death, peritoneal surface malignancies, HIPEC, Performance status, business.industry, Cytoreduction Surgical Procedures, Perioperative, Middle Aged, Prognosis, Surgery, Survival Rate, postoperative mortality, peritoneal metastasis, Peritoneal Cancer Index, Etiology, Female, Root Cause Analysis, Hyperthermic intraperitoneal chemotherapy, France, business, Root cause analysis
Abstract: International audience; Objective: To perform a retrospective root-cause analysis of postoperative death after CRS and HIPEC procedures. Background: The combination of CRS and HIPEC is an effective therapeutic strategy to treat peritoneal surface malignancies, however it is associated with significant postoperative mortality. Methods: All patients treated with a combination of CRS and HIPEC between January 2009 and December 2018 in 22 French centers and died in the hospital, were retrospectively analyzed. Perioperative data of the 101 patients were collected by a local senior surgeon with a sole junior surgeon. Three independent experts investigated the typical root cause of death and provided conclusions on whether postoperative death was preventable (PREV group) or not (NON-PREV group). A typical root cause of preventable postoperative death was classified on a cause-and-effect diagram. Results: Of the 5562 CRS+HIPEC procedures performed, 101 in-hospital deaths (1.8%) were identified, of which a total of 18 patients of 70 years old and above and 20 patients with ASA score of 3. Etiology of peritoneal disease was mainly colorectal. A total of 54 patients (53%) were classified in the PREV group and 47 patients (47%) in the NON-PREV group. The results of the study show that in the PREV group, WHO performance status 1-2 was more frequent and the Median Peritoneal Cancer Index was higher compared with those of the NON-PREV group. The cause of death in the PREV group was classified as: (i) preoperatively for debatable indication (59%), (ii) intraoperatively (30%) and (iii) postoperatively in 17 patients (31%). A multifactorial cause of death was found in 11 patients (20%). Conclusion: More than half of the postoperative deaths after combined CRS and HIPEC may be preventable, mainly by following guidelines regarding preoperative selection of the patients and adequate intraoperative decisions.
Published: 2021

46. Characterization of the proteome and metabolome of human liver sinusoidal endothelial-like cells derived from induced pluripotent stem cells

Author: Benedikt Scheidecker, Marjorie Leduc, Françoise Gilard, Rachid Jellali, Eric Leclerc, Bertrand Gakière, Atsushi Miyajima, Mathieu Danoy, Taketomo Kido, Yasuyuki Sakai, Fabrice Soncin, Johanna Bruce, Yannick Tauran, Laboratory for Integrated Micro Mechatronics Systems (LIMMS), The University of Tokyo (UTokyo)-Centre National de la Recherche Scientifique (CNRS), The University of Tokyo (UTokyo), Biomécanique et Bioingénierie (BMBI), Université de Technologie de Compiègne (UTC)-Centre National de la Recherche Scientifique (CNRS), Laboratoire des Multimatériaux et Interfaces (LMI), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut de Chimie du CNRS (INC)-Centre National de la Recherche Scientifique (CNRS), Plateforme protéomique 3P5 [Institut Cochin] (3P5), Institut Cochin (IC UM3 (UMR 8104 / U1016)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP), Institut des Sciences des Plantes de Paris-Saclay (IPS2 (UMR_9213 / UMR_1403)), Université d'Évry-Val-d'Essonne (UEVE)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Université d'Évry-Val-d'Essonne (UEVE)-Université Paris-Saclay-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Université de Lille-UNICANCER, LIMMS internal fundingFEDER through the « Operational Programme for Competitiveness Factors and employment 2007-2013 », ANR-16-RHUS-0005,iLite,iLite(2016), JELLALI, RACHID, and iLite - - iLite2016 - ANR-16-RHUS-0005 - RHUS - VALID
Subjects: 0301 basic medicine, Cancer Research, Proteome, Angiogenesis, Induced Pluripotent Stem Cells, LSECs, Biology, 03 medical and health sciences, 0302 clinical medicine, [SDV.BBM.GTP]Life Sciences [q-bio]/Biochemistry, Molecular Biology/Genomics [q-bio.GN], Metabolome, Humans, Liver Sinusoidal Endothelial Cells, Induced pluripotent stem cell, Molecular Biology, Cells, Cultured, proteomic, hiPSCs, CD40, Wnt signaling pathway, Endothelial Cells, Cell Differentiation, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Cell Biology, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Cell biology, human induced pluripotent stem cells, Endothelial stem cell, 030104 developmental biology, Liver, biology.protein, Hepatic stellate cell, [SDV.BBM.GTP] Life Sciences [q-bio]/Biochemistry, Molecular Biology/Genomics [q-bio.GN], Endothelium, Vascular, 030217 neurology & neurosurgery, Mannose receptor, metabolomic, Developmental Biology
Abstract: International audience; The liver is a complex organ composed of several cell types organized hierarchically. Among these, liver sinusoidal endothelial cells (LSECs) are specialized vascular cells known to interact with hepatocytes and hepatic stellate cells (HSCs), and to be involved in the regulation of important hepatic processes in healthy and pathological situations. Protocols for the differentiation of LSECs from human induced pluripotent stem cells, hiPSCs, have been proposed and in-depth analysis by transcriptomic profiling of those cells has been performed. In the present work, an extended analysis of those cells in terms of proteome and metabolome has been implemented. The proteomic analysis confirmed the expression of important endothelial markers and pathways. Among them, the expression of patterns typical of LSECs such as PECAM1, VWF, LYVE1, STAB1 (endothelial markers), CDH13, CDH5, CLDN5, ICAM1, MCAM-CD146, ICAM2, ESAM (endothelial cytoskeleton), NOSTRIN, NOS3 (Nitric Oxide endothelial ROS), ESM1, ENG, MMRN2, THBS1, ANGPT2 (angiogenesis), CD93, MRC1 (mannose receptor), CLEC14A (C-type lectin), CD40 (antigen), and ERG (transcription factor) was highlighted. Besides, the pathway analysis revealed the enrichment of the endocytosis, Toll-like receptor, Nod-like receptor, Wnt, Apelin, VEGF, cGMP-PCK, and PPAR related signaling pathways. Other important pathways such as vasopressin regulated water reabsorption, fluid shear stress, relaxin signaling, and renin secretion were also highlighted. At confluence, the metabolome profile appeared consistent with quiescent endothelial cell patterns. The integration of both proteome and metabolome datasets revealed a switch from fatty acid synthesis in undifferentiated hiPSCs to a fatty oxidation in LSECs and activation of the pentose phosphate pathway and polyamine metabolism in hiPSCs-derived LSECs. In conclusion, the comparison between the signature of LSECs differentiated following the protocol described in this work, and data found in the literature confirmed the particular relevance of these cells for future in vitro applications.
Published: 2021

47. Lack of Prognostic Value of CTNNB1 Mutation Profile in Desmoid-Type Fibromatosis

Author: Nicolas Penel, Sylvie Bonvalot, André-Michel Bimbai, Alexandra Meurgey, François Le Loarer, Sébastien Salas, Sophie Piperno-Neumann, Christine Chevreau, Pascaline Boudou-Rouquette, Pascale Dubray-Longeras, Jean-Emmanuel Kurtz, Cécile Guillemet, Emmanuelle Bompas, Antoine Italiano, Axel Le Cesne, Daniel Orbach, Julien Thery, Marie-Cécile Le Deley, Jean-Yves Blay, Olivier Mir, Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Institut Curie [Paris], Université de Bordeaux (UB), Service d’Oncologie Médicale [Hôpital de la Timone - APHM], Assistance Publique - Hôpitaux de Marseille (APHM)- Hôpital de la Timone [CHU - APHM] (TIMONE), Marseille medical genetics - Centre de génétique médicale de Marseille (MMG), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Méthodes computationnelles pour la prise en charge thérapeutique en oncologie : Optimisation des stratégies par modélisation mécaniste et statistique (COMPO), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Département d'Oncologie Médicale [Institut Curie, Paris], Institut Claudius Regaud, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), UNICANCER, Les Hôpitaux Universitaires de Strasbourg (HUS), Service d'Oncologie Médicale, CRLCC Haute Normandie-Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), Laboratory of Solid Tumors Genetics, Nice University Hospital, Institut de signalisation, biologie du développement et cancer (ISBDC), Université Nice Sophia Antipolis (1965 - 2019) (UNS), COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-COMUE Université Côte d'Azur (2015-2019) (COMUE UCA)-Centre National de la Recherche Scientifique (CNRS)-Université Côte d'Azur (UCA), Institut Gustave Roussy (IGR), Département de médecine oncologique [Gustave Roussy], Centre d'Etudes Médiévales de Montpellier (CEMM), Université Paul-Valéry - Montpellier 3 (UPVM), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Université Paris Descartes - Faculté de Médecine (UPD5 Médecine), and Université Paris Descartes - Paris 5 (UPD5)
Subjects: Cancer Research, MESH: Humans, Oncology, MESH: beta Catenin, MESH: Fibromatosis, Aggressive, MESH: Adult, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH: Female, MESH: Cohort Studies, MESH: Neoplasm Recurrence, Local, MESH: Male, MESH: Prognosis, MESH: Prospective Studies
Abstract: Purpose: This prospective nationwide cohort study aimed to investigate desmoid-type fibromatosis (DF) outcomes, focusing on the prognostic value of CTNNB1 mutations. Experimental Design: ALTITUDES (NCT02867033) was a nationwide prospective cohort study of DF diagnosed between January 2016 and December 2020. At diagnosis, CTNNB1 molecular alterations were identified using next-generation sequencing or Sanger sequencing. The primary endpoint was event-free survival (EFS; progression, relapse, or death). We enrolled 628 patients managed by active surveillance, surgical resection, or systemic treatment as first-line therapy. Results: Overall, 516 (82.2%) patients [368 females (71.3%), median age 40.3 years (range, 1–89)] were eligible for analysis. In 435 (84.3%) cases, there was one CTNNB1 molecular alteration: p.T41A, p.S45F, or p.S45P. The first-line management was active surveillance in 352 (68.2%), surgical resection in 120 (23.3%), and systemic treatments in 44 (8.5%) patients. CTNNB1 mutation distribution was similar across the three therapeutic groups. The median follow-up period was 24.7 (range, 0.4–59.7) months. The estimated 3-year EFS rate was 66.2% [95% confidence interval (CI), 60.5%–71.2%]. DF harboring p.S45F was significantly associated with male sex (P = 0.03), non-abdominal wall sites (P = 0.05), pain (P = 0.007), and large tumor size (P = 0.025). CTNNB1 p.S45F mutation was not significantly associated with EFS, either in univariate (HR, 1.06; 95% CI, 0.65–1.73; P = 0.81) or in multivariate analysis (HR, 0.91; 95% CI, 0.55–1.49; P = 0.71). Conclusions: We found that CTNNB1 mutation profile was associated with unfavorable prognostic factors but was not a prognostic factor for EFS. See related commentary by Greene and Van Tine, p. 3911
Published: 2022

48. Prevalence and mobility of integrative and conjugative elements within a Streptomyces natural population

Author: Choufa, Caroline, Tidjani, Abdoul-Razak, Gauthier, Anthony, Harb, Manar, Lao, Julie, Leblond-Bourget, Nathalie, Vos, Michiel, Leblond, Pierre, Bontemps, Cyril, Dynamique des Génomes et Adaptation Microbienne (DynAMic), Université de Lorraine (UL)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Mathématiques et Informatique Appliquées du Génome à l'Environnement [Jouy-En-Josas] (MaIAGE), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Region Grand-Est18_GE4_090, and ANR-11-LABX-0002,ARBRE,Recherches Avancées sur l'Arbre et les Ecosytèmes Forestiers(2011)
Subjects: Microbiology (medical), [SDV.EE.ECO]Life Sciences [q-bio]/Ecology, environment/Ecosystems, AICE, [SDV.BID.EVO]Life Sciences [q-bio]/Biodiversity/Populations and Evolution [q-bio.PE], evolution, integrative and conjugative element, population, gene transfer, genome, Microbiology, Streptomyces
Abstract: Horizontal Gene Transfer (HGT) is a powerful force generating genomic diversity in bacterial populations. HGT in Streptomyces is in large part driven by conjugation thanks to plasmids, Integrative and Conjugative elements (ICEs) and Actinomycete ICEs (AICEs). To investigate the impact of ICE and AICE conjugation on Streptomyces genome evolution, we used in silico and experimental approaches on a set of 11 very closely related strains isolated from a millimeter scale rhizosphere population. Through bioinformatic searches of canonical conjugation proteins, we showed that AICEs are the most frequent integrative conjugative elements, with the central chromosome region being a hotspot for integrative element insertion. Strains exhibited great variation in AICE composition consistent with frequent HGT and/or gene loss. We found that single insertion sites can be home to different elements in different strains (accretion) and conversely, elements belonging to the same family can be found at different insertion sites. A wide variety of cargo genes was present in the AICEs with the potential to mediate strain-specific adaptation (e.g., DNA metabolism and resistance genes to antibiotic and phages). However, a large proportion of AICE cargo genes showed hallmarks of pseudogenization, consistent with deleterious effects of cargo genes on fitness. Pock assays enabled the direct visualization of conjugal AICE transfer and demonstrated the transfer of AICEs between some, but not all, of the isolates. Multiple AICEs were shown to be able to transfer during a single mating event. Although we did not obtain experimental evidence for transfer of the sole chromosomal ICE in this population, genotoxic stress mediated its excision from the chromosome, suggesting its functionality. Our results indicate that AICE-mediated HGT in Streptomyces populations is highly dynamic, with likely impact on strain fitness and the ability to adapt to environmental change.
Published: 2022

49. Inherited TNFSF9 deficiency causes broad Epstein–Barr virus infection with EBV+ smooth muscle tumors

Author: Benjamin Fournier, Akihiro Hoshino, Julie Bruneau, Camille Bachelet, Mathieu Fusaro, Roman Klifa, Romain Lévy, Christelle Lenoir, Claire Soudais, Capucine Picard, Stéphane Blanche, Martin Castelle, Despina Moshous, Thierry Molina, Anne-Sophie Defachelles, Bénédicte Neven, Sylvain Latour, Activation lymphocytaire et susceptibilité au virus d’Epstein-Barr = Lymphocyte activation and susceptibility to EBV, Imagine - Institut des maladies génétiques (IHU) (Imagine - U1163), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, ANR-18-CE15-0025,ImmunoBioCTPS1,Comprendre la biologie et la physiopathologie de CTPS1, une nouvelle cible pour le développement d'immunosuppresseurs.(2018), Lymphocyte activation and susceptibility to EBV (Equpie Inserm U1163), and LATOUR, Sylvain
Subjects: [SDV] Life Sciences [q-bio], B-Lymphocytes, Epstein-Barr Virus Infections, Herpesvirus 4, Human, 4-1BB Ligand, T-Lymphocytes, [SDV]Life Sciences [q-bio], Immunology, Humans, Immunology and Allergy, Smooth Muscle Tumor
Abstract: International audience; Epstein–Barr virus (EBV) can infect smooth muscle cells causing smooth muscle tumors (SMTs) or leiomyoma. Here, we report a patient with a heterozygous 22q11.2 deletion/DiGeorge syndrome who developed a unique, broad, and lethal susceptibility to EBV characterized by EBV-infected T and B cells and disseminated EBV+SMT. The patient also harbored a homozygous missense mutation (p.V140G) in TNFSF9 coding for CD137L/4-1BBL, the ligand of the T cell co-stimulatory molecule CD137/4-1BB, whose deficiency predisposes to EBV infection. We show that wild-type CD137L was up-regulated on activated monocytes and dendritic cells, EBV-infected B cells, and SMT. The CD137LV140G mutant was weakly expressed on patient cells or when ectopically expressed in HEK and P815 cells. Importantly, patient EBV-infected B cells failed to trigger the expansion of EBV-specific T cells, resulting in decreased T cell effector responses. T cell expansion was recovered when CD137L expression was restored on B cells. Therefore, these results highlight the critical role of the CD137–CD137L pathway in anti-EBV immunity, in particular in the control of EBV+SMT.
Published: 2022

50. TACE and conformal radiotherapy vs. TACE alone for hepatocellular carcinoma: A randomised controlled trial

Author: Cyrille Féray, Loic Campion, Philippe Mathurin, Isabelle Archambreaud, Xavier Mirabel, Jean Pierre Bronowicki, Emmanuel Rio, Christophe Perret, Laurent Mineur, Frédéric Oberti, Yann Touchefeu, Jérôme Gournay, Hélène Regnault, Julien Edeline, Agnès Rode, Patrick Hillion, Jean Frédéric Blanc, Eric Nguyen Khac, Daniel Azoulay, Alain Luciani, Athena Galetto Preglisasco, Elodie Faurel-Paul, Hélène Auble, Françoise Mornex, Philippe Merle, Physiopathologie et traitement des maladies du foie, Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Service des Maladies de l'Appareil Digestif et de la Nutrition [CHRU Lille], Hôpital Claude Huriez [Lille], CHU Lille-CHU Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Institute for Translational Research in Inflammation - U 1286 (INFINITE (Ex-Liric)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre hospitalier universitaire de Nantes (CHU Nantes), Institut des Maladies de l'Appareil Digestif, Université de Nantes (UN), Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université de Lille-UNICANCER, Nutrition-Génétique et Exposition aux Risques Environnementaux (NGERE), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lorraine (UL), Service d'Hépato-gastro-entérologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Hôtel-Dieu de Nantes, Institut Sainte Catherine [Avignon], Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Service d'hépato-gastro-entérologie [APHP Henri Mondor], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Oncogenesis, Stress, Signaling (OSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Radiologie [Hôpital de la Croix-Rousse - HCL], Hôpital de la Croix-Rousse [CHU - HCL], Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Service d'Hépato-Gastro-Entérologie (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Bordeaux Research In Translational Oncology [Bordeaux] (BaRITOn), Université de Bordeaux (UB)-CHU Bordeaux [Bordeaux]-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Amiens-Picardie, Groupe de Recherche sur l'alcool et les pharmacodépendances - UMR INSERM_S 1247 (GRAP), Université de Picardie Jules Verne (UPJV)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Radiologie [Mondor], Centre pour l'innovation en cancérologie de Lyon (CICLY), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon, Service d'Oncologie Médicale [Centre hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Centre de Recherche en Cancérologie de Lyon (UNICANCER/CRCL), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service d'Hépatologie et de Gastroentérologie [Lyon], and Hospices Civils de Lyon (HCL)
Subjects: RILD, TTP, Hepatocellular carcinoma, ITT, overall survival, adverse event, time to tumour progression, PS, ALBI, mRECIST, ECOG, PFS, Barcelona Clinic Liver Cancer, hazard ratio, albumin–bilirubin, HR, Internal Medicine, radio-induced liver disease, Immunology and Allergy, HCC, 3-DCRT, propensity score, TACE, SBRT, Conformal external radiotherapy, Hepatology, Gastroenterology, AE, OS, computed tomography, transcatheter arterial chemoembolisation, three-dimensional conformal radiotherapy, intention-to-treat, BCLC, clinical tumour volume, stereotaxic body radiation therapy, Eastern Cooperative Oncology Group, CRT, CTV, conformal radiotherapy, progression-free survival, modified Response Evaluation Criteria in Solid Tumour, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, CT
Abstract: International audience; Background & aims: Transcatheter arterial chemoembolisation (TACE) is recommended for patients with hepatocellular carcinoma devoid of macrovascular invasion or extrahepatic spread but not eligible for curative therapies. We compared the efficacy and safety of the combination of a single TACE and external conformal radiotherapy (CRT) vs. classical TACE.Methods: TACERTE was an open-labelled, randomised controlled trial with a 1:1 allocation rate to two or three TACE (arm A) or one TACE + CRT (arm B). Participants had a mean age of 70 years, and 86% were male. The aetiology was alcohol in 85%. The primary endpoint was liver progression-free survival (PFS) in the intention-to-treat population. The typical CRT schedule was 54 Gy in 18 sessions of 3 Gy.Results: Of the 120 participants randomised, 64 were in arm A and 56 in arm B; 100 participants underwent the planned schedule and defined the 'per-protocol' group. In intention-to-treat participants, the liver PFS at 12 and 18 months were 59% and 19% in arm A and 61% and 36% in arm B (hazard ratio [HR] 0.69; 95% CI 0.40-1.18; p = 0.17), respectively. In the per-protocol population, treated liver PFS tended to be better in arm B (HR 0.61; 95% CI 0.34-1.06; p = 0.081) than in arm A. Liver-related grade III-IV adverse events were more frequent in arm B than in arm A. Median overall survival reached 30 months (95% CI 23-35) in arm A and 22 months (95% CI 15.7-26.2) in arm B.Conclusions: Although TACE + CRT tended to improve local control, this first Western randomised controlled trial showed that the combined strategy failed to increase PFS or overall survival and led more frequently to liver-related adverse effects.Impact and implications: Hepatocellular carcinoma is frequently treated by arterial embolisation of the tumour and more recently by external radiotherapy. We tried to determine whether combination of the two treatments (irradiation after embolisation) might produce interesting results. Our results in this prospective randomised study were not able to demonstrate a beneficial effect of combining embolisation and irradiation in these patients. On the contrary, we observed more adverse effects with the combined treatment.
Published: 2023

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