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1. Randomized phase II trial in prostate cancer with hormone-sensitive OligometaSTatic relapse: Combining stereotactic ablative radiotherapy and durvalumab (POSTCARD GETUG P13): Study protocol

Author

Maximilien Rogé, Yoann Pointreau, Paul Sargos, Emmanuel Meyer, Ulrike Schick, Ali Hasbini, Emmanuel Rio, Guillaume Bera, Amandine Ruffier, Magali Quivrin, Mathieu Chasseray, Igor Latorzeff, Etienne Martin, Valentine Guimas, Pascal Pommier, Thomas Leroy, Philippe Ronchin, Alexis Lepinoy, Audrey Grand, Lysian Cartier, Ossama Didas, Fabrice Denis, Vincent Libois, Audrey Blanc-Lapierre, and Stéphane Supiot

Subjects
Prostate cancer, Oligorecurrent, Oligometastases, Stereotactic body radiotherapy, Immunotherapy, Medical physics. Medical radiology. Nuclear medicine, R895-920, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: As in other solid tumors, increasing evidence indicates that patients diagnosed with a limited number of prostate cancer metastases, so-called oligometastases, have a better prognosis than patients with extensive metastatic disease. Stereotactic body radiotherapy (SBRT) is now considered an option in this population.Programmed death-1 (PD-1) and its ligands (PD-L1) are targeted by immune checkpoint inhibitors. Preclinical studies have shown that the tumor immune microenvironment changes when combining radiotherapy with immunotherapy, especially with hypofractionated radiotherapy.The oligometastatic setting appears to be the most relevant clinical situation for evaluating the immune response generated by radiotherapy and immune checkpoint inhibitors in patients with an intact immune system.We hypothesize that durvalumab will enhance the immune response following SBRT targeting oligometastatic lesions. Our purpose is to demonstrate, via a randomized 2:1 phase II trial, that SBRT (3 fractions) with durvalumab in oligometastatic hormone-sensitive prostate cancer patients would improve progression-free survival in patients with prostate cancer with up to 5 metastases compared to patients who exclusively received SBRT. Methods: This is a multicentric randomized phase II study in French academic hospitals. Patients with prostate cancer and up to 5 metastases (lymph node and/or bone) were randomized into a 2:1 ratio between Arm A (experimental group), corresponding to durvalumab and SBRT to the metastases, and Arm B (control group), corresponding to SBRT alone to the metastases. The study aims to accrue a total of 96 patients within 3 years. The primary endpoint is two-year progression-free survival and secondary endpoints include androgen deprivation therapy-free survival, quality of life, toxicity, prostate cancer specific survival, overall survival, and immune response. Discussion: The expected benefit for the patients in the experimental arm is longer life expectancy with acceptable toxicity. We also expect our study to provide data for better understanding the synergy between immunotherapy and radiotherapy in oligometastatic prostate cancer.

Published
2023
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2. Physical Activity Program for the Survival of Elderly Patients With Lymphoma: Study Protocol for Randomized Phase 3 Trial

Author

Jonas Dubu, Sébastien Boyas, Virginie Roland, Sébastien Landry, Anne-Lise Septans, Magali Balavoine, Hugues Bourgeois, Yoann Pointreau, Fabrice Denis, Christophe Letellier, and Katell Le Dû

Subjects
Medicine, Computer applications to medicine. Medical informatics, R858-859.7
Abstract

BackgroundThe practice of regular physical activity can reduce the incidence of certain cancers (colon, breast, and prostate) and improve overall survival after treatment by reducing fatigue and the risk of relapse. This impact on survival has only been demonstrated in active patients with lymphoma before and after treatment. As poor general health status reduces the chances of survival and these patients are most likely to also have sarcopenia, it is important to be able to improve their physical function through adapted physical activity (APA) as part of supportive care management. Unfortunately, APA is often saved for patients with advanced blood cancer. As a result, there is a lack of data regarding the impact of standardized regular practice of APA and concomitant chemotherapy as first-line treatment on lymphoma survival. ObjectiveThis study aimed to assess the impact of a new and open rehabilitation program suitable for a frail population of patients treated for diffuse large B-cell lymphoma (DLBCL). MethodsPHARAOM (Physical Activity Program for the Survival of Elderly Patients with Lymphoma) is a phase 3 randomized (1:1) study focusing on a frail population of patients treated for DLBCL. The study will include 186 older adult patients with DLBCL (aged >65 years) receiving rituximab and chemotherapy. Overall, 50% (93/186) of patients (investigational group) will receive APA along with chemotherapy, and they will be supervised by a dedicated qualified kinesiologist. The APA program will include endurance and resistance training at moderate intensity 3 times a week during the 6 months of chemotherapy. The primary end point of this study will be event-free survival of the patients. The secondary end points will include the overall survival, progression-free survival, prevalence of sarcopenia and undernutrition, and patients’ quality of life. This study will be conducted in accordance with the principles of the Declaration of Helsinki. ResultsRecruitment, enrollment, and data collection began in February 2021, and 4 participants have been enrolled in the study as of July 2022. Data analysis will begin after the completion of data collection. Future outcomes will be published in peer-reviewed health-related research journals and presented at national congress, and state professional meetings. This publication is based on protocol version 1.1, August 3, 2020. ConclusionsThe PHARAOM study focuses on highlighting the benefits of APA intervention on survival during the period of first-line treatment of patients with DLBCL. This study could also contribute to our understanding of how an APA program can reduce complications such as sarcopenia in patients with lymphoma and improve their quality of life. By documenting the prevalence and relationship between sarcopenia and exercise load, we might be able to help physicians plan better interventions in the care of patients with DLBCL. Trial RegistrationClinicalTrials.gov NCT04670029; https://clinicaltrials.gov/ct2/show/NCT04670029 International Registered Report Identifier (IRRID)DERR1-10.2196/40969

Published
2022
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3. Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial

Author

Florence Legouté, René-Jean Bensadoun, Valérie Seegers, Yoann Pointreau, Delphine Caron, Philippe Lang, Alain Prévost, Laurent Martin, Ulrike Schick, Benjamin Morvant, Olivier Capitain, Gilles Calais, and Eric Jadaud

Subjects
Oral mucositis, Chemoradiotherapy, Head and neck cancer, Lasertherapy, Supportive care, Medical physics. Medical radiology. Nuclear medicine, R895-920, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Low-level laser therapy (LLLT) also called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, however randomised data about efficacy and safety are missing with curative dose 4 J/cm2. Methods This phase III trial was conducted in patients with oral cavity, or oro/hypopharyngeal cancers (stage III or IV). Patients were treated by lasertherapy on OM lesions grade ≥ 2 (4 J/cm2 or placebo), during chemoradiotherapy and until recovery. Severity of OM (incidence and duration of grades ≥3) was used as primary endpoint and blindly assessed. Results Among 97 randomised patients, 83 patients (85.6%) could be assessed finally (erroneous inclusions, chemoradiotherapy interruptions) and 32 patients had no lasertherapy because of unreachable OM lesions. Randomisation and population characteristics (sex ratio, age, chemoradiotherapy procedures, toxicities incidence) were still comparable between the two LLLT/PBMT groups. An acute OM (grade ≥ 3) was observed in 41 patients (49.4%): 23 patients (54.8%) of the active laser group versus 18 (43.9%) in the control group (modified intend to treat, p = 0.32). Median time before occurrence of OM ≥ grade 3 in half of the patients was 8 weeks in active laser group (vs. 9 weeks in control group). However, 95% of patients exhibited a very good tolerance of LLLT/PBMT. Conclusions This study assessed LLLT/PBMT according to the Multinational Association of Supportive care in Cancer recommendations but lacked power. LLLT/PBMT was well tolerated with a good safety profile, which promotes its use in clinical routine for severe OM treatment. Trial registration ClinicalTrials.gov Identifier: NCT01772706. Title: Laser Mucite ORL: Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite). Study Start Date: October 2008. Primary Completion Date: October 2016. Responsible Party: Institut de Cancérologie de l’Ouest – Paul Papin. Principal Investigator: Eric Jadaud, M.D., Institut de Cancérologie de l’Ouest – Paul Papin. Funding: French Ministry of Health, French national funding scheme (PHRC 2008).

Published
2019
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4. Factors associated with under-reporting of head and neck squamous cell carcinoma in cause-of-death records: A comparative study of two national databases in France from 2008 to 2012.

Author

Caroline Even, Luis Sagaon Teyssier, Yoann Pointreau, Stéphane Temam, Florence Huguet, Lionnel Geoffrois, Michaël Schwarzinger, and EPICORL Study Group

Subjects
Medicine, Science
Abstract

ObjectiveTo date, no study has evaluated the detection rate of head and neck squamous cell carcinoma (HNSCC) in cause-of-death records in Europe. Our objectives were to compare the number of deaths attributable to HNSCC from two national databases in France and to identify factors associated with under-reporting of HNSCC in cause-of-death records.MethodsThe national hospital discharge database and the national underlying cause-of-death records were compared for all HNSCC-attributable deaths in adult patients from 2008 to 2012 in France. Factors associated with under-reporting of HNSCC in cause-of-death records were assessed using multivariate Poisson regression.ResultsA total of 41,503 in-hospital deaths were attributable to HNSCC as compared to 25,647 deaths reported in national UCoD records (a detection rate of 62%). Demographics at death were similar in both databases with respect to gender (83% men), age (54% premature deaths at 25-64 years), and geographic distribution. In multivariate Poisson regression, under-reporting of HNSCC in cause-of-death records significantly increased in 2012 compared to 2010 (+7%) and was independently associated with a primary HNSCC site other than the larynx, a former primary or second synchronous cancer other than HNSCC, distant metastasis, palliative care, and death in hospitals other than comprehensive cancer care centers. The main study results were robust in a sensitivity analysis which also took into account deaths outside hospital (overall, 51,129 HNSCC-attributable deaths; a detection rate of 50%). For the year 2012, the age-standardized mortality rate for HNSCC derived from underlying cause-of-death records was less than half that derived from hospital discharge summaries (14.7 compared to 34.1 per 100,000 for men and 2.7 compared to 6.2 per 100,000 for women).ConclusionHNSCC is largely under-reported in cause-of-death records. This study documents the value of national hospital discharge databases as a complement to death certificates for ascertaining cancer deaths.

Published
2021
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6. A Rare Case of Radiation-Induced Osteosarcoma of the Ethmoid Sinus

Author

Musaed Alzahrani, Alain Robier, Yoann Pointreau, and David Bakhos

Subjects
Otorhinolaryngology, RF1-547
Abstract

Radiation therapy has been recognized as a useful modality of treatment in head and neck malignant tumors. However, radiation over 10 Gy may predispose to secondary tumors. Radiation-induced osteosarcoma of the ethmoid sinus is unusual. These tumors may present long after radiation with epistaxis. Computed tomography, magnetic resonance imaging, and biopsy are the modalities of diagnosis. We report a case of radiation-induced osteosarcoma of the ethmoid sinus 9 years after initial exposure. We describe the clinical presentation, the radiological findings, and the management.

Published
2011
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7. Extended follow-up of a phase 2 trial of xevinapant plus chemoradiotherapy in high-risk locally advanced squamous cell carcinoma of the head and neck: a randomised clinical trial

Author

Yungan TAO, Xu-Shan Sun, Yoann Pointreau, Christophe Le Tourneau, Christian Sire, Marie-Christine Kaminsky, Alexandre Coutte, Marc Alfonsi, Benôit Calderon, Pierre Boisselier, Laurent Martin, Jessica Miroir, Jean-Francois Ramee, Jean-Pierre Delord, Florian Clatot, Frederic Rolland, Julie Villa, Nicolas Magne, Olgun Elicin, Elisabeta Gherga, France Nguyen, Cédrik Lafond, Guillaume Bera, Valentin Calugaru, Lionnel Geoffrois, Bruno Chauffert, Lars Damstrup, Philippa Crompton, Abdallah Ennaji, Kathrin Gollmer, Heidi Nauwelaerts, Jean Bourhis, Centre Hospitalier Universitaire de Nice (CHU Nice), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Centre Jean Bernard [Institut Inter-régional de Cancérologie - Le Mans], 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), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, 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), Institut Sainte Catherine [Avignon], Institut du Cancer de Montpellier (ICM), Aix-Marseille Université - Faculté de pharmacie (AMU PHARM), Aix Marseille Université (AMU), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), 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-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Département d'oncologie médicale [Rouen], Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), and Centre Hospitalier Universitaire [Grenoble] (CHU)

Subjects
Xevinapant, Cancer Research, Efficacy, Survival, Oncology, Locally advanced squamous cell carcinoma of the head and neck, 610 Medicine & health, Chemoradiotherapy, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Introduction: We report long-term efficacy and overall survival (OS) results from a randomised, double-blind, phase 2 study (NCT02022098) investigating xevinapant plus standard-of-care chemoradiotherapy (CRT) vs. placebo plus CRT in 96 patients with unresected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN).Methods: Patients were randomised 1:1 to xevinapant 200 mg/day (days 1-14 of a 21-day cycle for 3 cycles), or matched placebo, plus CRT (cisplatin 100 mg/m2 every 3 weeks for 3 cycles plus conventional fractionated high-dose intensity-modulated radiotherapy [70 Gy/35 F, 2 Gy/F, 5 days/week for 7 weeks]). Locoregional control, progression-free survival, and duration of response after 3 years, long-term safety, and 5-year OS were assessed.Results: The risk of locoregional failure was reduced by 54% for xevinapant plus CRT vs. placebo plus CRT but did not reach statistical significance (adjusted hazard ratio [HR] 0.46; 95% CI, 0.19-1.13; P = .0893). The risk of death or disease progression was reduced by 67% for xevinapant plus CRT (adjusted HR 0.33; 95% CI, 0.17-0.67; P = .0019). The risk of death was approximately halved in the xevinapant arm compared with placebo (adjusted HR 0.47; 95% CI, 0.27-0.84; P = .0101). OS was prolonged with xevinapant plus CRT vs. placebo plus CRT; median OS not reached (95% CI, 40.3-not evaluable) vs. 36.1 months (95% CI, 21.8-46.7). Incidence of late-onset grade ≥3 toxicities was similar across arms.Conclusions: In this randomised phase 2 study of 96 patients, xevinapant plus CRT demonstrated superior efficacy benefits, including markedly improved 5-year survival in patients with unresected LA SCCHN.

Published
2023
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8. Effectiveness of naloxegol in patients with cancer pain suffering from opioid-induced constipation

Author

Yoann Pointreau, Viorica Braniste, François-Xavier Piloquet, Bérengère Narciso, Antoine Lemaire, and Jean-Marc Sabate

Subjects
Male, medicine.medical_specialty, Constipation, Pain medicine, medicine.medical_treatment, Laxative, Pain, Naloxegol, Polyethylene Glycols, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Neoplasms, Internal medicine, medicine, Humans, 030212 general & internal medicine, Adverse effect, Aged, Cancer, business.industry, Correction, Cancer Pain, Middle Aged, medicine.disease, Analgesics, Opioid, Opioids, Morphinans, Oncology, chemistry, Opioid, 030220 oncology & carcinogenesis, Quality of Life, Original Article, medicine.symptom, Cancer pain, business, Opioid-Induced Constipation, Follow-Up Studies, medicine.drug
Abstract

Purpose Naloxegol, an oral once-daily peripherally acting mu-opioid receptor antagonist, is indicated for the treatment of opioid-induced constipation (OIC) with inadequate response to laxative(s), in cancer and non-cancer patients. This study mainly aimed to assess in real-life conditions the efficacy and safety of naloxegol in cancer pain patients and the evolution of their quality of life. Methods A non-interventional, 4-week follow-up study was conducted in 24 French oncology and pain centers between 2018 and 2019. Eligible patients were aged ≥ 18 years, treated with opioids for cancer pain, and started naloxegol for OIC with inadequate response to laxatives. The rate of the response to naloxegol (primary criterion) was assessed at W4. The evolution of quality of life was measured using the Patient Assessment of Constipation Quality of Life (PAC-QOL). Results A total of 124 patients were included (mean age, 62 ± 12 years; ECOG ≤ 2, 79%; primary cancer, lung 18%, breast 16%, prostate 11%, head and neck 9%, digestive 9%…; metastatic stage, 80%). At inclusion, the median opioid dosage was 60 mg of oral morphine or equivalent. At W4, the response rate was 73.4% (95% CI [63.7–83.2%]), and 62.9% (95% CI [51.5–74.2%]) of patients had a clinically relevant change in quality of life (decrease in PAC-QOL score ≥ 0.5 point). Adverse events related to naloxegol were reported in 8% of patients (7% with gastrointestinal events; one serious diarrhea). Conclusion This real-world study shows that naloxegol is effective and well tolerated in cancer pain patients with OIC and that their quality of life improves under treatment.

Published
2021

9. Correction to: Effectiveness of naloxegol in patients with cancer pain suffering from opioid‑induced constipation

Author

Antoine Lemaire, François‑Xavier Piloquet, Yoann Pointreau, Jean‑Marc Sabaté, Viorica Braniste, and Bérengère Narciso

Subjects
medicine.medical_specialty, business.industry, Pain medicine, Nursing research, MEDLINE, Naloxegol, chemistry.chemical_compound, Opioid induced constipation, Oncology, chemistry, Physical therapy, medicine, In patient, Cancer pain, business
Published
2021

10. Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial

Author

Stéphanie Wong Hee Kam, Michel Rives, P. Boisselier, Yungan Tao, Yoann Pointreau, S. Heymann, Marc Alfonsi, Julian Biau, Ovidiu Veresezan, X. Sun, Cedrik Lafond, Pierre Blanchard, A. Cornely, Sophie Renard-Oldrini, Anne Auperin, Juliette Thariat, Odile Casiraghi, Pierre Graff, Jean Bourhis, Joël Castelli, Michel Lapeyre, Institut Gustave Roussy (IGR), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Département de radiothérapie [Gustave Roussy], Institut Sainte Catherine [Avignon], Hôpital Nord Franche-Comté [Hôpital de Trévenans] (HNFC), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut Claudius Regaud, Centre Jean Bernard [Institut Inter-régional de Cancérologie - Le Mans], Centre Eugène Marquis (CRLCC), Centre Alexis Vautrin (CAV), Hôpital de la Timone [CHU - APHM] (TIMONE), 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)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, 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 Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), Centre Hospitalier Universitaire Vaudois [Lausanne] (CHUV), Génétique, immunothérapie, chimie et cancer (GICC), UMR 7292 CNRS [2012-2017] (GICC UMR 7292 CNRS), Université de Tours-Centre National de la Recherche Scientifique (CNRS), Centre Jean Bernard [Le Mans], service de radiothérapie, UNICANCER-UNICANCER, 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]), Radiation Oncology Service, Normandie Université (NU)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Centre National de la Recherche Scientifique (CNRS), and COLO, Mouniati

Subjects
medicine.medical_specialty, Intensity-modulated radiotherapy, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Cell, Locally advanced, [SDV.CAN]Life Sciences [q-bio]/Cancer, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, otorhinolaryngologic diseases, medicine, Clinical endpoint, Humans, Radiology, Nuclear Medicine and imaging, IMRT, Stage (cooking), Head and neck cancer, Cisplatin, Dose escalation, Squamous Cell Carcinoma of Head and Neck, business.industry, Radiotherapy Dosage, Chemoradiotherapy, Hematology, medicine.disease, Concurrent chemoradiotherapy, 3. Good health, [SDV] Life Sciences [q-bio], Radiation therapy, stomatognathic diseases, medicine.anatomical_structure, Oncology, Head and Neck Neoplasms, 030220 oncology & carcinogenesis, Concomitant, Radiotherapy, Intensity-Modulated, Radiology, business, medicine.drug
Abstract

International audience; Background: Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy.Methods: Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP).Results: 188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found.Conclusion: Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.

Published
2020

11. Patient Satisfaction with Fentanyl Pectin Nasal Spray in Breakthrough Cancer Pain Management During Radiotherapy for Head and Neck Cancer

Author

Christian Sire, René-Jean Bensadoun, G. Bera, Xavier Amores, Gilles Calais, Amandine Ruffier, Baptiste Pinel, Yoann Pointreau, Viorica Braniste, Guillaume Janoray, and Marc A. Bollet

Subjects
medicine.medical_specialty, business.industry, Health Policy, medicine.medical_treatment, 05 social sciences, Head and neck cancer, Medicine (miscellaneous), medicine.disease, 0506 political science, 03 medical and health sciences, 0302 clinical medicine, Patient satisfaction, Nasal spray, Quality of life, Tolerability, Internal medicine, 050602 political science & public administration, medicine, 030212 general & internal medicine, Adverse effect, business, Prospective cohort study, Cancer pain, Pharmacology, Toxicology and Pharmaceutics (miscellaneous), Social Sciences (miscellaneous)
Abstract

Objective The severity of breakthrough cancer pain (BTcP) impacts patients' quality of life, increases the risk of anxiety and depression, lowers functional capacities, and may lead to poor compliance with cancer treatments. The aim of the current study was to assess, in a real-life setting, patient satisfaction with a fentanyl-pectin-nasal-spray (FPNS) for BTcP management in head and neck (H&N) cancer patients treated by radiotherapy. Materials and Methods This non-interventional, prospective study was conducted in 92 adult H&N-cancer patients undergoing radiotherapy and who started FPNS treatment for BTcP. Throughout the radiotherapy period, the patients completed self-diaries to assess their BTcP episodes, FPNS use, satisfaction on FPNS efficiency (primary outcome), tolerability and ease of use. Results Prior to FPNS treatment, 86% of the patients were experiencing ≤4 BTcP episodes/day. During the radiotherapy period, the BTcP episodes were treated with a median dose of 100µg of FPNS. Patients were "satisfied/very-satisfied" with the efficiency (73% of assessments), ease of use (87% of assessments) and tolerability (87% of assessments) of FPNS. In total, 27% of patients reported at least one adverse event related to FPNS and 4% of patients discontinued treatment due to adverse events. None of the adverse events were serious. Patient quality of life was maintained throughout the radiotherapy period. Conclusion This study showed, in a real-life setting, that a clear majority of H&N cancer patients treated with FPNS for BTcP throughout radiotherapy expressed satisfaction with this analgesic treatment.

Published
2020

12. Sarcopenia in metastatic cancer patients: results of a prospective non-randomized study

Author

Eric Voog, Jonas Dubu, Fabrice Denis, Hassan Rabi, Lydie Serre, Anne-Lise Septans, Yoann Pointreau, Olivier Dupuis, Julien Domont, Amandine Ruffier, Katell Le Du, Sophie Roche, and H Bourgeois

Subjects
Oncology, medicine.medical_specialty, Randomized controlled trial, business.industry, law, Sarcopenia, Internal medicine, Medicine, Cancer, business, medicine.disease, law.invention
Abstract

Background Prognostic factors can impact the quality of life and overall survival in metastatic situations: sarcopenia and nutritional status disorders. Methods We conducted a non-interventional, observational prospective study during 3 consecutive months (SPACE trial, ClinicalTrials.gov identifier: NCT04714203). Performance status, lumbar skeletal muscle index (by CT scan), albumin, C-reactive protein, or LDH, were collected from medical records in the classic balance sheet at inclusion and then at 3 and 6 months after the day of inclusion. Results 38 patients were included with a median age of 68 years old and 31 were evaluable for sarcopenia. 58.1% of patients with metastatic cancer were sarcopenic at the diagnosis and 61% at 6 months. At the inclusion, 87.5% of sarcopenic patients were men (p

Published
2021

13. Chemotherapy and radiotherapy in locally advanced head and neck cancer: an individual patient data network meta-analysis

Author

Brian O'Sullivan, Everett E. Vokes, J. Bernier, J. Vermorken, Jean-Jacques Mazeron, J.W. Lee, J. Simes, Carlo Fallai, P. Olmi, Cai Grau, K.H. Cho, B. Lacas, J.J. Cruz Hernandez, P. Graff-Cailleaud, Branislav Jeremic, J. Overgaard, Giuseppe Sanguineti, J.H. Hay, Voichita Bar-Ad, B. Gery, H. Quon, W. Dobrowsky, B. Maciejewski, M. Nankivell, Catherine Fortpied, Y. Belkacemi, Z. Szutkowski, V. Budach, David J. Adelstein, Maria Grazia Ghi, Allan Hackshaw, A. Trotti, Vincent Grégoire, Jens Overgaard, P. Blanchard, David I. Rosenthal, B. O'Sullivan, B.G. Haffty, Ju-Whei Lee, E. Moyal, M. Alfonsi, O. Choussy, S. Kumar, Barbara Burtness, M. Cheugoua-Zanetsie, C.M.P. Viegas, V. Tseroni, E. Lartigau, H. Bartelink, Björn Zackrisson, Jean-Pierre Pignon, S. Staar, J. Waldron, J.S. Wu, A. Lopes, M.G. Ghi, Sarbani Ghosh Laskar, Lisa Licitra, K.D Wernecke, C. Grau, Y.G. Tao, J. Agarwal, Yoann Pointreau, Maurice Cheugoua-Zanetsie, M. Lotayef, G. Calais, Claire Petit, J. Moon, J.A. Langendijk, C.A. Kristensen, W. Budach, Mahesh K.B. Parmar, Mahesh K. B. Parmar, Athanassios Argiris, Benjamin Lacas, C. Sire, S. Spencer, Beth M. Beadle, C. Petit, John Simes, Michael Poulsen, Arlene A. Forastiere, Q.T. Le, Adam S. Garden, L.P. Zhong, J.J. Mazeron, H. van Tinteren, Å. Bratland, Jean Pierre Pignon, Yi Li, Jeffrey S Tobias, S.H. Moon, P. Strojan, J. Bourhis, S. Temam, A. Bacigalupo, Pedro A. Torres-Saavedra, E.E. Vokes, C.M.L. Driessen, Stéphane Temam, M.M Dominello, E. Chamorey, J. Widder, Ricardo Hitt, C. van Herpen, Séverine Racadot, M. Julieron, H. Yamazaki, Rafał Suwiński, Z. Takácsi-Nagy, A. Hansen, K. Skladowski, D. Chaukar, P. Lee, S. Hayoz, F. Lewin, Marshall R. Posner, Atul Sharma, S. Mehta, M.G. Poulsen, S. Ghosh Laskar, R. Suwinski, B. Campbell, Wojciech Michalski, Jimmy J. Caudell, Jørgen Johansen, C. Simon, C. Fortpied, R. Orecchia, Volker Budach, George Shenouda, V. Torri, Shaleen Kumar, E Haddad, P. Rovea, P. Torres-Saavedra, Juan Jesús Cruz Hernández, Lai-Ping Zhong, Quynh-Thu Le, B. Zaktonik, J.W. Denham, A. Aupérin, B. Zackrisson, Gregory T. Wolf, J.C. Horiot, C. Stromberger, Jean Bourhis, S. Chabaud, Michel Lapeyre, Eric Lartigau, S.J. Wong, George Fountzilas, P. Nilsson, David M. Brizel, M.R. Posner, L. Tripcony, René-Jean Bensadoun, C. Jones, M.G. Ruo Redda, Pierre Blanchard, D. Thomson, A. Hackshaw, B. Jeremic, G. Sanguineti, Pirus Ghadjar, A. Auperin, P. Garaud, Damage and Repair in Cancer Development and Cancer Treatment (DARE), and Guided Treatment in Optimal Selected Cancer Patients (GUTS)

Subjects
Male, Oncology, medicine.medical_specialty, medicine.medical_treatment, Network Meta-Analysis, Head and Neck Neoplasms/mortality, chemotherapy, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, head and neck cancer, radiotherapy, chemotherapy, radiochemotherapy, 030212 general & internal medicine, radiotherapy, business.industry, Head and neck cancer, Hazard ratio, Dose fractionation, Induction chemotherapy, Cancer, Chemoradiotherapy, medicine.disease, Radiation therapy, Head and Neck Neoplasms, 030220 oncology & carcinogenesis, Concomitant, Female, head and neck cancer, radiochemotherapy, Dose Fractionation, Radiation, business, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9]
Abstract

Contains fulltext : 235407.pdf (Publisher’s version ) (Closed access) BACKGROUND: Randomised, controlled trials and meta-analyses have shown the survival benefit of concomitant chemoradiotherapy or hyperfractionated radiotherapy in the treatment of locally advanced head and neck cancer. However, the relative efficacy of these treatments is unknown. We aimed to determine whether one treatment was superior to the other. METHODS: We did a frequentist network meta-analysis based on individual patient data of meta-analyses evaluating the role of chemotherapy (Meta-Analysis of Chemotherapy in Head and Neck Cancer [MACH-NC]) and of altered fractionation radiotherapy (Meta-Analysis of Radiotherapy in Carcinomas of Head and Neck [MARCH]). Randomised, controlled trials that enrolled patients with non-metastatic head and neck squamous cell cancer between Jan 1, 1980, and Dec 31, 2016, were included. We used a two-step random-effects approach, and the log-rank test, stratified by trial to compare treatments, with locoregional therapy as the reference. Overall survival was the primary endpoint. The global Cochran Q statistic was used to assess homogeneity and consistency and P score to rank treatments (higher scores indicate more effective therapies). FINDINGS: 115 randomised, controlled trials, which enrolled patients between Jan 1, 1980, and April 30, 2012, yielded 154 comparisons (28 978 patients with 19 253 deaths and 20 579 progression events). Treatments were grouped into 16 modalities, for which 35 types of direct comparisons were available. Median follow-up based on all trials was 6·6 years (IQR 5·0-9·4). Hyperfractionated radiotherapy with concomitant chemotherapy (HFCRT) was ranked as the best treatment for overall survival (P score 97%; hazard ratio 0·63 [95% CI 0·51-0·77] compared with locoregional therapy). The hazard ratio of HFCRT compared with locoregional therapy with concomitant chemoradiotherapy with platinum-based chemotherapy (CLRT(P)) was 0·82 (95% CI 0·66-1·01) for overall survival. The superiority of HFCRT was robust to sensitivity analyses. Three other modalities of treatment had a better P score, but not a significantly better HR, for overall survival than CLRT(P) (P score 78%): induction chemotherapy with taxane, cisplatin, and fluorouracil followed by locoregional therapy (IC(TaxPF)-LRT; 89%), accelerated radiotherapy with concomitant chemotherapy (82%), and IC(TaxPF) followed by CLRT (80%). INTERPRETATION: The results of this network meta-analysis suggest that further intensifying chemoradiotherapy, using HFCRT or IC(TaxPF)-CLRT, could improve outcomes over chemoradiotherapy for the treatment of locally advanced head and neck cancer. FUNDINGS: French Institut National du Cancer, French Ligue Nationale Contre le Cancer, and Fondation ARC.

Published
2021

14. Risk factors for Coronavirus Disease 2019 (COVID-19) severity and mortality among solid cancer patients and impact of the disease on anticancer treatment: A French nationwide cohort study (GCO-002 CACOVID-19)

Author

Astrid Lièvre, Anthony Turpin, Isabelle Ray-Coquard, Karine Le Malicot, Juliette Thariat, Guido Ahle, Cindy Neuzillet, Xavier Paoletti, Olivier Bouché, Kais Aldabbagh, Pierre Michel, Didier Debieuvre, Anthony Canellas, Marie Wislez, Lucie Laurent, May Mabro, Raphael Colle, Anne-Claire Hardy-Bessard, Laura Mansi, Emeline Colomba, Jean Bourhis, Philippe Gorphe, Yoann Pointreau, Ahmed Idbaih, Renata Ursu, Anna Luisa Di Stefano, Gérard Zalcman, Thomas Aparicio, Solenne Moulin, Olivier Leleu, Sylvie Leparree, Henri Goasdoue, Christine Piprot, Gerald Tourneur, Vincent Bayart, Delphine Lignier, Emma Lachaier, Marwa Khamari, Alexandre Coutte, Nicolas Siembida, Aline Houessinon, Jean Marc Regimbeau, Bruno Chauffert, Aurélie Moreira, Vincent Hautefeuille, Christine Hee, Mathieu Boone, Céline Bihan, Emilie Chive, Stéphane Poulet-Potriquier, Rachida Fahem, Dominique Luet, Guillaume Roquin, Carole Vitellius, Nathanaëlle Cornet-Trichereau, François-Xavier Caroli-Bosc, Anne Thirot-Bidault, Stanislas Ropert, Julie Gachet - Masson, Mélanie Dehais, Gwen-Ael L'helgoualc'h, Ibrahim Ali-Mahamadou, Safia Talfi, Laure Belmont, Dieudonné Kilendo, Nasro Benrezzak, Emeline Dubief, Guillaume Conroy, Laurence Delique, Maud Basso, Isabelle Pons, Karine Salignon, Anne-Laure Villing, Emmanuelle Mougenot, Cassandra Porebski, Asma Guiatni, Nicolas Cloarec, Laurent Mineur, Marie Bouchaud, Céleste David, Annie Peytier, Thomas Greletty, Franck Audemar, Emanuelle Vignes, Floriane Minne, Guillaume Goldzak, Fabienne Huysman, Fayçal Hocine, Zaher Lakkis, Guillaume Meynard, Hamadi Almotlak, Elodie Klajer, Xu-Shan Sun, Julie Wasselin, Pascale Catala, Claire Mazuy, Hélène Vandamme, Jean-Briac Prevost, Aurélie Fadin, Laurent Basson, Jean-Baptiste Huguet, Emmanuelle Dos Santos, Bérangère Jany, Alain Saad, Frédéric Goutorbe, Eric Oziol, Mohamed Ramdani, Ouafae Kadiri, Delphine Garbay, Clotilde Huet, Etienne Giroux Leprieur, Wen Teng, Justine Monvoisin, Patrick Arnaud Coffin, Sylvie Roux, Hubert Orfeuvre, Mélanie Chagros, Didier Pillon, Agathe Rassoul, Pierre Guillaume Poureau, Cécile Novello, François Ducray, Cécile Trouba, Vianney Bastit, Emmanuel Babin, Vincent Leon, Anne-Catherine Courtecuisse, Julie Vambre, Vincent Tack, Christophe Desauw, Fatima Meniai, Christina Peres, Aurélie Esparcieux, Hervé Perrier, Nathalie Doux, Régis Kaphan, Bertrand Roques, Christine Rebischung, Dominique Mille, Gaëlle Fernandes, Naceur Abdelli, Natacha Jousset, Pierre Combe, Eric Jonveaux, Patrick Dumont, Marc Kanaan, Corinne Berthelot Gras, Valérie Panis, Laure Kaluzinski, Marjolène Venant-Valery, You-Heng Lam, Laura Vallee, Frédéric Riviere, Muriel Durand, Dihya Benghadid, Emilie Villeneuve, Olivia Hentic Dhome, Zedjiga Bounouar, Louis De Mestier, Jacqueline Dubois, Magali Eyriey, Lionel Moreau, Dib Baihas, Kaïs Aldabbagh, Dominique Degriffolet, Virginie Sebbagh, Jean-Christophe Seghezzi, Marion Lozach-Brugirard, Julie Mandrou, Loubna Mavier, Florence Hennetier, Jean-Philippe Wagner, Elisabeth Carola, Karthiga Chandirakumaran, Sandrine Loutski, Isabelle Cojean-Zelek, Amina Bouras, Sandrine Lacour, Fahem Froura, Hadjer Ben Nadji, Sophie Cattelain, Franck Darloy, Geneviève Jolimoy Boilleau, Cyrielle Maissiat, Ariane Darut-Jouve, Véronique Lorgis, Ikram Charifi-Alaoui, François Ghiringhelli, Antoine Drouillard, Marie Chaix, Sylvain Manfredi, Côme Lepage, Alice Gagnaire, Marianne Latournerie, Sofia jourdan, Nora Perrot, Mireille folia, Anne Minello, Jean-Louis Jouve, Marielle Fery, Alain Landau, Diane Evrard, Bruno Valenza, Jean-François Paitel, Laetitia Chablais, Thomas Kreitmann, Laurence Lancry-Lecomte, Adrien Monard, Eve Faugeras, Paul Boucheret, Cécile Glommeau, Christine Tchikladze, Claire Garnier Tixidre, Jérôme Long, Manel Zaidi, Véronique Delabarre, Juliette Meyzenc, Loïc Ferrand, Denis Moro-Sibilot, Paul Bouheret, Cécile Leyronnas, Camille Herve, Audrey Thoor, Emanuelle Jacquet, Gaël Roth, Videsheka Madapathage-Senanyake, Peggy Chupeau, Elsa Bieber, Maud Rosso, Isabelle Lepage, Frank Priou, Margot Laly, Sylvie Aprelon, Natacha Sobolak, Helen Homokos, Fabienne Watelle, Alice Pham-Becker, Géraldine Lauridant, Charlotte Dujardin, Etienne Lenglin, Aimée Nienguet Tsota, Sophie Dominguez, Alexandra Forestier, Franck Nouvel, Justine Lerooy, Céline Ratajczak, Olivier Romano, Dorothéee Brzyski, Aurélien Barriere, Dominique Genet, Julien Tisse, Xavier Zasadny, Adeline Grelet, Amélie Hennion-Imbault, Eglantine Haustraete, Samy Louafi, Manal Awad, Younes Zekri, Caroline Cheneau, Nolwen Leissen, Joëlle Egreteau, Alexandra Breant, Matthieu Sarabi, Stéphanie Labonne, Julien Forestier, Céline Leclercq, Florence Prunier-Bossion, Isabelle Ray Coquard, Marielle Guillet, Aurélie Theillaumas, Emilie Prome, Thomas Walter, Pierre Philouze, Melody Lawo, Solène De Talhouet, Johanne Beuvelot, Yann Molin, Marie Bellecoste Martin, Maud Saussereau, Lauren Agnelli, Nicolas Fakhry, Christophe Laplace, Emmanuelle Norguet Monnereau, Céline Boucard, Kahina Djenad, Catherine Fontaine, Jean-François Seitz, Laétitia Dahan, Julie Sigrand, Muriel Duluc, Christophe Locher, Marjory Fleury, Ange Brou Marie, Ramdane Berkane, Séverine Poupblanc, Dominique Auby, Daniela Petran, Patrick Texereau, Elodie Guerineau, Morgan Andre, Linda Mahjoubi, Fanny Sarrazin, Sonia Jeanson, Anthony Gschwend, Virginie Birr, Mathieu Fore, Monique Noirclerc, Sihem Dahou, Dominique Spaeth, Mélanie Lambotin, Thomas Lelu, Benjamin Linot, Nathalie Hugon, Dominique Rousseau, Hélène Castanie, Carole Lenne, Alain Lortholary, Anatole Cessot, Messaouda Merzoug, Cécile Naudin, Jean-Michel Vannetzel, Ghina Aziz, Yacine Hadj Arab, Stéphanie Pernes, Isabelle Roche-Lachaise, Frédéric Fiteni, Hadjer Yahiaoui, Gwendoline Marel Lopez, Jeanne Oddoz, Fabienne Peira, Olivier Michel, Jérôme Meunier, Brahim Ouahrani, Antoine Roger, Sonia Branco, Van Nguyen, Mathilde Gisselbrecht, Ghania Hammad, Pierre Mordant, Magda Stroksztejn, Marc Pocard, Luc Nlo Meyengue, Emmanuelle Sacco, Sophie Simon Anne, Elizabeth Fabre-Guillevin, Marine Slim, Aziz Zaanan, Jacques Cadranel, Johan Pluvy, Rénata Ursu, Amyrath Geraldo, Rime Lihi, Maryline Vo, Zohra Brouk, Raphaël Colle, Mostefa Bennamoun, Fabrice Lacan, Christophe Louvet, Soraya Mebarki, Marianne Veyri, Elena Paillaud, Christelle Lucas, Olivier Dubreuil, Jamila Lyamani, Hanane Agguini, Emilie Soularue, Clément Jourdaine, Benjamin Verillaud, Hakima Herzine, Eric Raymond, Nathalie Mathiot, Lola Jade Palmieri, Christian Epanya, Julien Taieb, Eliane Bertrand, Gaël Goujon, Céline Namour, Benoit Gazeau, Biljana Zafirova, Haitham Mirghani, Catherine Belin, Kahina Belkhir, Myriam Gharib, Aurore Vozy, Karim Amrane, Jean-Philippe Spano, Johanna Wassermann, Loic Feuvret, Jean-Baptiste Bachet, Sara Philonenko, Laetitia Guillot, Marion Zabbe, Stéphanie Gibiat, Camille Baylot, Aude Jouinot, Nicolas Leduc, Sabine Vieillot, Laurie James, Camille Ducerf, Jean-Frédéric Blanc, Claire Falandry Leger, Virginie Wautot, Marion Chauvenet, Aude Vincent, David Tougeron, Sandrine Goulvent, Etienne Suc, Anne-Pascale Laurenty, Eric Marquis, Margaux Bonnaire, Maxime Dewolf, Esteban Brenet, Delphine Billard, Claude-Fabien Litre, Antoine Dumazet, Damien Botsen, Marion Vazel, Claire Carlier, David Bonnerave, Charles Marchand-Crety, Olivier Bouche, Patricia Fosse, David Sefrioui, Sarah Watson, Fatah Torche, Thierry Muron, Stéphane Natur, Romain Desgrippes, Véronique Bihel, François-Régis Ferrand, Caroline Leiterer, Julie Lavole, Claire Moquet, Nathalie Pressoir, Catherine Dziukala, Catherine Ligeza Poisson, Abdelhalim Naji, Nicolas Williet, Jean-Marc Phelip, Fabrice Di Palma, Amina Kherrour Mehdi, Julien Langrand-Escure, Pierre Fournel, Grégoire Pigne, Léa Saban-Roche, Nicolas Magne, Cécile Vassal, Jean-Philippe Jacquin, Carole Ramirez, Alexis Vallard, Olivier Collard, Romain Rivoirard, Ivan Graber, Stéphanie Trager Maury, Elodie Duboisset, Jorge Ayllon Ugarte, Dalilia Rami, Christine Saler, Manon Reinbolt, Clara Le Fevre, Meher Ben Abdelghani, Louis-Marie Dourthe, Joffrey Perruisseau-Carrier, Marlène Nguimpi-Tambou, Flavie Barret, Luisa Di Stefano Anna, Annie Balthazard, Camille Vassord-Dang, Mathilde Le Marchand, Julien Vergniol, Iulia Pripon, Axelle Daemaegdt, Vanessa Latry, Muna Larrieu, Gaëlle Landry, Laetitia Touihri Maximin, Francesco Del Piano, Agnès Barlet, Mylène Vernisse, Sophie Lafond, Charline Genin, Camille Sibertin-Blanc, Emilien Chabrillac, Caroline Gregoire, Sébastien Vergez, Quentin Panouille, Rosine Guimbaud, Floriane Richa, Loïc Lebellec, Sophie Gounin, Guillaume Buiret, Marine Baudin, Hervé Hamon, Anne-Claire Deshorgue, Eduardo Barrascout, Stéphanie Legrand, Morgane Houlze, Linda Cambula, Anthony Lopez, Guillaume Fouquet, Kahina Touabi, Adeline GermaIn, Benoit Godbert, Florence Voivret, Julie Perrin, Rosa Da Silva, Emilie Bernichon, GCO-002 CACOVID-19 collaborators/investigators, Moulin, S., Leleu, O., Leparree, S., Goasdoue, H., Piprot, C., Tourneur, G., Bayart, V., Lignier, D., Lachaier, E., Khamari, M., Coutte, A., Siembida, N., Houessinon, A., Regimbeau, J.M., Chauffert, B., Moreira, A., Hautefeuille, V., Hee, C., Boone, M., Bihan, C., Chive, E., Poulet-Potriquier, S., Fahem, R., Luet, D., Roquin, G., Vitellius, C., Cornet-Trichereau, N., Caroli-Bosc, F.X., Thirot-Bidault, A., Ropert, S., Gachet-Masson, J., Dehais, M., L'helgoualc'h, G.A., Ali-Mahamadou, I., Talfi, S., Belmont, L., Kilendo, D., Benrezzak, N., Dubief, E., Conroy, G., Delique, L., Basso, M., Pons, I., Salignon, K., Villing, A.L., Mougenot, E., Porebski, C., Guiatni, A., Cloarec, N., Mineur, L., Bouchaud, M., David, C., Peytier, A., Greletty, T., Audemar, F., Vignes, E., Minne, F., Goldzak, G., Huysman, F., Hocine, F., Lakkis, Z., Mansi, L., Meynard, G., Almotlak, H., Klajer, E., Sun, X.S., Wasselin, J., Catala, P., Mazuy, C., Vandamme, H., Prevost, J.B., Fadin, A., Basson, L., Huguet, J.B., Dos Santos, E., Jany, B., Saad, A., Goutorbe, F., Oziol, E., Ramdani, M., Kadiri, O., Garbay, D., Huet, C., Giroux Leprieur, E., Teng, W., Monvoisin, J., Arnaud Coffin, P., Roux, S., Orfeuvre, H., Chagros, M., Pillon, D., Rassoul, A., Poureau, P.G., Novello, C., Ducray, F., Trouba, C., Bastit, V., Babin, E., Thariat, J., Leon, V., Courtecuisse, A.C., Vambre, J., Tack, V., Desauw, C., Meniai, F., Peres, C., Esparcieux, A., Perrier, H., Doux, N., Kaphan, R., Roques, B., Rebischung, C., Mille, D., Fernandes, G., Abdelli, N., Jousset, N., Combe, P., Jonveaux, E., Dumont, P., Kanaan, M., Berthelot Gras, C., Panis, V., Kaluzinski, L., Venant-Valery, M., Lam, Y.H., Vallee, L., Riviere, F., Durand, M., Benghadid, D., Villeneuve, E., Hentic Dhome, O., Laurent, L., Bounouar, Z., De Mestier, L., Dubois, J., Eyriey, M., Moreau, L., Ahle, G., Baihas, D., Aldabbagh, K., Degriffolet, D., Sebbagh, V., Seghezzi, J.C., Lozach-Brugirard, M., Mandrou, J., Mavier, L., Hennetier, F., Wagner, J.P., Carola, E., Chandirakumaran, K., Loutski, S., Cojean-Zelek, I., Bouras, A., Lacour, S., Froura, F., Ben Nadji, H., Cattelain, S., Darloy, F., Jolimoy Boilleau, G., Maissiat, C., Darut-Jouve, A., Lorgis, V., Charifi-Alaoui, I., Ghiringhelli, F., Drouillard, A., Chaix, M., Manfredi, S., Lepage, C., Gagnaire, A., Latournerie, M., Jourdan, S., Perrot, N., Folia, M., Minello, A., Jouve, J.L., Fery, M., Landau, A., Evrard, D., Valenza, B., Paitel, J.F., Chablais, L., Kreitmann, T., Lancry-Lecomte, L., Monard, A., Faugeras, E., Boucheret, P., Glommeau, C., Tchikladze, C., Garnier Tixidre, C., Long, J., Zaidi, M., Delabarre, V., Meyzenc, J., Ferrand, L., Moro-Sibilot, D., Bouheret, P., Leyronnas, C., Herve, C., Thoor, A., Jacquet, E., Roth, G., Madapathage-Senanyake, V., Chupeau, P., Bieber, E., Rosso, M., Lepage, I., Priou, F., Laly, M., Aprelon, S., Sobolak, N., Homokos, H., Pointreau, Y., Watelle, F., Pham-Becker, A., Lauridant, G., Turpin, A., Dujardin, C., Lenglin, E., Nienguet Tsota, A., Dominguez, S., Forestier, A., Nouvel, F., Lerooy, J., Ratajczak, C., Romano, O., Brzyski, D., Barriere, A., Genet, D., Tisse, J., Zasadny, X., Grelet, A., Hennion-Imbault, A., Haustraete, E., Louafi, S., Awad, M., Zekri, Y., Cheneau, C., Leissen, N., Egreteau, J., Breant, A., Sarabi, M., Labonne, S., Forestier, J., Leclercq, C., Prunier-Bossion, F., Ray Coquard, I., Guillet, M., Theillaumas, A., Prome, E., Walter, T., Philouze, P., Lawo, M., De Talhouet, S., Beuvelot, J., Molin, Y., Bellecoste Martin, M., Saussereau, M., Agnelli, L., Fakhry, N., Laplace, C., Norguet Monnereau, E., Boucard, C., Djenad, K., Fontaine, C., Seitz, J.F., Dahan, L., Sigrand, J., Duluc, M., Locher, C., Fleury, M., Brou Marie, A., Berkane, R., Poupblanc, S., Auby, D., Petran, D., Texereau, P., Guerineau, E., Andre, M., Mahjoubi, L., Sarrazin, F., Jeanson, S., Gschwend, A., Birr, V., Debieuvre, D., Fore, M., Noirclerc, M., Dahou, S., Spaeth, D., Lambotin, M., Lelu, T., Linot, B., Hugon, N., Rousseau, D., Castanie, H., Lenne, C., Lortholary, A., Cessot, A., Merzoug, M., Naudin, C., Vannetzel, J.M., Aziz, G., Hadj Arab, Y., Pernes, S., Roche-Lachaise, I., Fiteni, F., Yahiaoui, H., Marel Lopez, G., Oddoz, J., Peira, F., Michel, O., Meunier, J., Ouahrani, B., Roger, A., Branco, S., Nguyen, V., Gisselbrecht, M., Hammad, G., Mordant, P., Stroksztejn, M., Pocard, M., Nlo Meyengue, L., Aparicio, T., Sacco, E., Simon Anne, S., Fabre-Guillevin, E., Wislez, M., Slim, M., Zaanan, A., Cadranel, J., Pluvy, J., Ursu, R., Geraldo, A., Lihi, R., Vo, M., Brouk, Z., Colle, R., Bennamoun, M., Lacan, F., Louvet, C., Mebarki, S., Veyri, M., Paillaud, E., Lucas, C., Dubreuil, O., Lyamani, J., Idbaih, A., Agguini, H., Soularue, E., Canellas, A., Zalcman, G., Jourdaine, C., Verillaud, B., Herzine, H., Raymond, E., Mathiot, N., Palmieri, L.J., Epanya, C., Taieb, J., Bertrand, E., Goujon, G., Namour, C., Gazeau, B., Zafirova, B., Mirghani, H., Belin, C., Belkhir, K., Gharib, M., Vozy, A., Amrane, K., Spano, J.P., Wassermann, J., Feuvret, L., Bachet, J.B., Philonenko, S., Guillot, L., Zabbe, M., Gibiat, S., Baylot, C., Jouinot, A., Leduc, N., Vieillot, S., James, L., Ducerf, C., Blanc, J.F., Falandry Leger, C., Wautot, V., Chauvenet, M., Vincent, A., Tougeron, D., Goulvent, S., Suc, E., Laurenty, A.P., Marquis, E., Bonnaire, M., Dewolf, M., Brenet, E., Billard, D., Litre, C.F., Dumazet, A., Botsen, D., Vazel, M., Carlier, C., Bonnerave, D., Marchand-Crety, C., Bouche, O., Fosse, P., Sefrioui, D., Michel, P., Watson, S., Neuzillet, C., Torche, F., Muron, T., Natur, S., Desgrippes, R., Bihel, V., Ferrand, F.R., Leiterer, C., Lavole, J., Moquet, C., Pressoir, N., Dziukala, C., Ligeza Poisson, C., Naji, A., Williet, N., Phelip, J.M., Di Palma, F., Kherrour Mehdi, A., Langrand-Escure, J., Fournel, P., Pigne, G., Saban-Roche, L., Magne, N., Vassal, C., Jacquin, J.P., Ramirez, C., Vallard, A., Collard, O., Rivoirard, R., Graber, I., Trager Maury, S., Duboisset, E., Ayllon Ugarte, J., Rami, D., Saler, C., Reinbolt, M., Le Fevre, C., Ben Abdelghani, M., Dourthe, L.M., Perruisseau-Carrier, J., Nguimpi-Tambou, M., Barret, F., Di Stefano Anna, L., Balthazard, A., Mabro, M., Vassord-Dang, C., Le Marchand, M., Vergniol, J., Pripon, I., Daemaegdt, A., Latry, V., Larrieu, M., Landry, G., Touihri Maximin, L., Del Piano, F., Barlet, A., Vernisse, M., Lafond, S., Genin, C., Sibertin-Blanc, C., Chabrillac, E., Gregoire, C., Vergez, S., Panouille, Q., Guimbaud, R., Richa, F., Lebellec, L., Gounin, S., Buiret, G., Baudin, M., Hamon, H., Deshorgue, A.C., Barrascout, E., Legrand, S., Houlze, M., Cambula, L., Lopez, A., Fouquet, G., Touabi, K., GermaIn, A., Godbert, B., Voivret, F., Perrin, J., Da Silva, R., Bernichon, E., Chemistry, Oncogenesis, Stress and Signaling (COSS), Université de Rennes (UR)-CRLCC Eugène Marquis (CRLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], 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), Centre Léon Bérard [Lyon], Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), CH Colmar, Institut Curie [Paris], Centre Hospitalier Universitaire de Reims (CHU Reims), Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Emile Muller [Mulhouse] (CH E.Muller Mulhouse), Groupe Hospitalier de Territoire Haute Alsace (GHTHA), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), AP-HP - Hôpital Cochin Broca Hôtel Dieu [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital Beaujon, Hôpital Foch [Suresnes], CHU Saint-Antoine [AP-HP], ARCAGY-GINECO, Interactions hôte-greffon-tumeur, ingénierie cellulaire et génique - UFC (UMR INSERM 1098) (RIGHT), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS BFC)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC), Institut Gustave Roussy (IGR), Département de médecine nucléaire [Rennes], CRLCC Eugène Marquis (CRLCC), Département de médecine oncologique [Gustave Roussy], Département de cancérologie cervico-faciale [Gustave Roussy] (CCF), Centre Jean Bernard [Institut Inter-régional de Cancérologie - Le Mans], Institut du Cerveau = Paris Brain Institute (ICM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Hopital Saint-Louis [AP-HP] (AP-HP), Unité de génétique et biologie des cancers (U830), Institut Curie [Paris]-Institut National de la Santé et de la Recherche Médicale (INSERM), AbbVie, Merck, Carthera, Transgene, Nutritheragene, Roche, Air Liquide, Eli Lilly Japan, LEO Pharma Research Foundation, Bayer, Novartis, Sanofi, Biogen, Institut National de la Santé et de la Recherche Médicale (INSERM)-CRLCC Eugène Marquis (CRLCC)-Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES), Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement français du sang [Bourgogne-Franche-Comté] (EFS [Bourgogne-Franche-Comté])-Université de Franche-Comté (UFC), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Male, 0301 basic medicine, Cancer Research, medicine.medical_treatment, Disease, law.invention, Cohort Studies, 0302 clinical medicine, Mechanical ventilation, Risk Factors, law, Neoplasms, Medicine, Prospective Studies, Prospective cohort study, Original Research, Cancer, Intensive care unit, 3. Good health, Death, Oncology, 030220 oncology & carcinogenesis, Female, France, Immunotherapy, Cohort study, medicine.medical_specialty, chemotherapy. radiotherapy, Antineoplastic Agents, [SDV.CAN]Life Sciences [q-bio]/Cancer, 03 medical and health sciences, Internal medicine, Humans, Chemotherapy, Mortality, Pandemics, Aged, Retrospective Studies, Radiotherapy, SARS-CoV-2, business.industry, COVID-19, Retrospective cohort study, Odds ratio, medicine.disease, Antineoplastic Agents/adverse effects, Antineoplastic Agents/therapeutic use, COVID-19/mortality, France/epidemiology, Neoplasms/mortality, Neoplasms/therapy, Neoplasms/virology, SARS-CoV-2/isolation & purification, 030104 developmental biology, business
Abstract

Background Cancer patients are thought to have an increased risk of developing severe Coronavirus Disease 2019 (COVID-19) infection and of dying from the disease. In this work, predictive factors for COVID-19 severity and mortality in cancer patients were investigated. Patients and Methods In this large nationwide retro-prospective cohort study, we collected data on patients with solid tumours and COVID-19 diagnosed between March 1 and June 11, 2020. The primary endpoint was all-cause mortality and COVID-19 severity, defined as admission to an intensive care unit (ICU) and/or mechanical ventilation and/or death, was one of the secondary endpoints. Results From April 4 to June 11, 2020, 1289 patients were analysed. The most frequent cancers were digestive and thoracic. Altogether, 424 (33%) patients had a severe form of COVID-19 and 370 (29%) patients died. In multivariate analysis, independent factors associated with death were male sex (odds ratio 1.73, 95%CI: 1.18-2.52), ECOG PS ≥ 2 (OR 3.23, 95%CI: 2.27-4.61), updated Charlson comorbidity index (OR 1.08, 95%CI: 1.01-1.16) and admission to ICU (OR 3.62, 95%CI 2.14-6.11). The same factors, age along with corticosteroids before COVID-19 diagnosis, and thoracic primary tumour site were independently associated with COVID-19 severity. None of the anticancer treatments administered within the previous 3 months had any effect on mortality or COVID-19 severity, except cytotoxic chemotherapy in the subgroup of patients with detectable SARS-CoV-2 by RT-PCR, which was associated with a slight increase of the risk of death (OR 1.53; 95%CI: 1.00-2.34; p = 0.05). A total of 431 (39%) patients had their systemic anticancer treatment interrupted or stopped following diagnosis of COVID-19. Conclusions Mortality and COVID-19 severity in cancer patients are high and are associated with general characteristics of patients. We found no deleterious effects of recent anticancer treatments, except for cytotoxic chemotherapy in the RT-PCR-confirmed subgroup of patients. In almost 40% of patients, the systemic anticancer therapy was interrupted or stopped after COVID-19 diagnosis., Highlights • A total of 1289 patients with solid tumours and COVID-19 were analysed. • Mortality and COVID-19 severity were mainly driven by patient general characteristics. • Overall, we found no deleterious effects of recent anticancer treatments on mortality. . • Systemic anticancer treatment was interrupted or stopped in 39% of patients.

Published
2020

15. Induction Chemotherapy Followed by Cetuximab Radiotherapy Is Not Superior to Concurrent Chemoradiotherapy for Head and Neck Carcinomas: Results of the GORTEC 2007-02 Phase III Randomized Trial

Author

Yoann Pointreau, Emmanuel Babin, Bernard Gery, Frederic Rolland, Joëlle Buffet, Cedric Khoury, Xu Shan Sun, Jean Bourhis, Pierre Guillet, Marc Alfonsi, Michel Lapeyre, Lionnel Geoffrois, Anne Rose Henry, François Guichard, Dominique De Raucourt, Ali Hasbini, Christian Sire, Marie Saliou, C. Tuchais, Pascal Garaud, Christian Borel, Philippe Maingon, Yungan Tao, Eric Jadaud, Jean-Marc Tourani, Ayman Zawadi, Nicolas Meert, Marie-Christine Kaminsky, Alexandre Coutte, Cédric Lafond, Laurent Martin, and Marie-Hélène Calais

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Standard of care, Cetuximab, business.industry, medicine.medical_treatment, Locally advanced, Induction chemotherapy, Concurrent chemoradiotherapy, law.invention, Radiation therapy, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Randomized controlled trial, law, 030220 oncology & carcinogenesis, Internal medicine, medicine, Head and neck, business, medicine.drug
Abstract

Purpose Both concurrent chemoradiotherapy (CT-RT) and cetuximab radiotherapy (cetux-RT) have been established as the standard of care for the treatment of locally advanced squamous cell carcinoma of the head and neck. It was not known whether the addition of induction chemotherapy before cetux-RT could improve outcomes compared with standard of care CT-RT. Patients and Methods The current trial was restricted to patients with nonmetastatic N2b, N2c, or N3 squamous cell carcinoma of the head and neck and fit for taxotere, cisplatin, fluorouracil (TPF). Patients were randomly assigned to receive three cycles of TPF followed by cetux-RT versus concurrent carboplatin fluorouracil and RT as recommended in National Comprehensive Cancer Network guidelines. The trial was powered to detect a hazard ratio (HR) of 0.66 in favor of TPF plus cetux-RT for progression-free survival at 2 years. The inclusion of 180 patients per arm was needed to achieve 80% power at a two-sided significance level of .05. Results Between 2009 and 2013, 370 patients were included. All patients and tumors characteristics were well balanced between arms. There were more cases of grade 3 and 4 neutropenia in the induction arm, and the induction TPF was associated with 6.6% treatment-related deaths. With a median follow-up of 2.8 years, 2-year progression-free survival was not different between both arms (CT-RT, 0.38 v TPF + cetux-RT, 0.36; HR, 0.93 [95% CI, 0.73 to 1.20]; P = .58). HR was 0.98 (95% CI, 0.74 to 1.3; P = .90) for locoregional control and 1.12 (95% CI, 0.86 to 1.46; P = .39) for overall survival. These effects were observed regardless of p16 status. The rate of distant metastases was lower in the TPF arm (HR, 0.54 [95% CI, 0.30 to 0.99]; P = .05). Conclusion Induction TPF followed by cetux-RT did not improve outcomes compared with CT-RT in a population of patients with advanced cervical lymphadenopathy.

Published
2018

16. Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial

Author

Laurent Martin, Philippe Lang, René-Jean Bensadoun, Alain Prévost, Eric Jadaud, Florence Legouté, Ulrike Schick, Valérie Seegers, Yoann Pointreau, Delphine Caron, Gilles Calais, Olivier Capitain, Benjamin Morvant, Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Service d'Oncologie médicale [CHU Pitié-Salpêtrière], CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut Jean Godinot [Reims], Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier Universitaire d'Angers (CHU Angers), and PRES Université Nantes Angers Le Mans (UNAM)

Subjects
Male, lcsh:Medical physics. Medical radiology. Nuclear medicine, medicine.medical_specialty, medicine.medical_treatment, lcsh:R895-920, [SDV]Life Sciences [q-bio], Population, [SDV.CAN]Life Sciences [q-bio]/Cancer, Placebo, Severity of Illness Index, lcsh:RC254-282, Oral mucositis, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Clinical endpoint, Mucositis, Humans, Medicine, Radiology, Nuclear Medicine and imaging, Low-Level Light Therapy, education, Head and neck cancer, Low level laser therapy, Aged, Stomatitis, education.field_of_study, business.industry, Research, Chemoradiotherapy, Middle Aged, Prognosis, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Lasertherapy, 3. Good health, Radiation therapy, Oncology, Head and Neck Neoplasms, 030220 oncology & carcinogenesis, Carcinoma, Squamous Cell, Quality of Life, Female, business, Supportive care
Abstract

Low-level laser therapy (LLLT) also called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, however randomised data about efficacy and safety are missing with curative dose 4 J/cm2. This phase III trial was conducted in patients with oral cavity, or oro/hypopharyngeal cancers (stage III or IV). Patients were treated by lasertherapy on OM lesions grade ≥ 2 (4 J/cm2 or placebo), during chemoradiotherapy and until recovery. Severity of OM (incidence and duration of grades ≥3) was used as primary endpoint and blindly assessed. Among 97 randomised patients, 83 patients (85.6%) could be assessed finally (erroneous inclusions, chemoradiotherapy interruptions) and 32 patients had no lasertherapy because of unreachable OM lesions. Randomisation and population characteristics (sex ratio, age, chemoradiotherapy procedures, toxicities incidence) were still comparable between the two LLLT/PBMT groups. An acute OM (grade ≥ 3) was observed in 41 patients (49.4%): 23 patients (54.8%) of the active laser group versus 18 (43.9%) in the control group (modified intend to treat, p = 0.32). Median time before occurrence of OM ≥ grade 3 in half of the patients was 8 weeks in active laser group (vs. 9 weeks in control group). However, 95% of patients exhibited a very good tolerance of LLLT/PBMT. This study assessed LLLT/PBMT according to the Multinational Association of Supportive care in Cancer recommendations but lacked power. LLLT/PBMT was well tolerated with a good safety profile, which promotes its use in clinical routine for severe OM treatment. ClinicalTrials.gov Identifier: NCT01772706 . Title: Laser Mucite ORL: Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite). Study Start Date: October 2008. Primary Completion Date: October 2016. Responsible Party: Institut de Cancerologie de l’Ouest – Paul Papin. Principal Investigator: Eric Jadaud, M.D., Institut de Cancerologie de l’Ouest – Paul Papin. Funding: French Ministry of Health, French national funding scheme (PHRC 2008).

Published
2019

17. Unilateral or bilateral irradiation in cervical lymph node metastases of unknown primary? A retrospective cohort study

Author

J. Khalifa, C. Pflumio, Shakeel Sumodhee, Matthieu Caubet, Ludivine Catteau, Xu Shan Sun, Amel Rehailia-Blanchard, A. Beddok, Vincent Roth, I. Troussier, Joël Castelli, Marco Krengli, Charles Dupin, Nicolas Blanchard, Valentin Calugaru, Jean-Christophe Faivre, Yoann Pointreau, Juliette Thariat, Julia Salleron, Jessica Miroir, Mélanie Doré, Edouard Romano, Paul Giraud, Samir H. Patel, S. Servagi-Vernat, Alexandre Coutte, René-Jean Bensadoun, Claire Petit, Lionnel Geoffrois, Yungan Tao, Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER, Hôpital Nord Franche-Comté [Hôpital de Trévenans] (HNFC), Institut Gustave Roussy (IGR), Service de Radiothérapie [CHRU Besançon], Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Institut Jean Godinot [Reims], CRLCC Eugène Marquis (CRLCC), Centre Jean Perrin [Clermont-Ferrand] (UNICANCER/CJP), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), CHU Amiens-Picardie, Service d'Oncologie radiothérapie [Clinique Victor Hugo], Clinique Victor Hugo [Le Mans], Mayo Clinic, CHU Saint-Etienne, Centre hospitalier universitaire de Poitiers (CHU Poitiers), EASY CRF : la recherche clinique en ligne, and ARCHADE (Advanced Resource Centre for HADrontherapy in Europe)

Subjects
Male, 0301 basic medicine, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Neck dissection, Head and neck neoplasms, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Cervical lymphadenopathy, Neoplasms, Chemotherapy, Radiotherapy, Unknown primary, Carcinoma, Humans, Medicine, Cumulative incidence, Lymph node, Aged, Retrospective Studies, Squamous Cell Carcinoma of Head and Neck, business.industry, Retrospective cohort study, Middle Aged, medicine.disease, 3. Good health, Surgery, Radiation therapy, 030104 developmental biology, medicine.anatomical_structure, Oncology, Lymphatic Metastasis, 030220 oncology & carcinogenesis, Concomitant, Neoplasms, Unknown Primary, Female, Lymph Nodes, medicine.symptom, business
Abstract

Patients with cervical lymphadenopathy of unknown primary carcinoma (CUP) usually undergo neck dissection and irradiation. There is an ongoing controversy regarding the extent of nodal and mucosal volumes to be irradiated. We assessed outcomes after bilateral or unilateral nodal irradiation.This retrospective multicentre study included patients with CUP and squamous cellular carcinoma who underwent radiotherapy (RT) between 2000 and 2015.Of 350 patients, 74.5% had unilateral disease and 25.5% had bilateral disease. Of 297 patients with available data on disease and irradiation sides, 61 (20.5%) patients had unilateral disease and unilateral irradiation, 155 (52.2%), unilateral disease and bilateral irradiation and 81 (27.3%), bilateral disease and bilateral irradiation. Thirty-four (9.7%) and 217 (62.0%) patients received neoadjuvant and/or concomitant chemotherapy, respectively. Median follow-up was 37 months. Three-year local, regional, locoregional failure rates and CUP-specific survival were 5.6%, 11.7%, 15.0% and 84.7%, respectively. In patients with unilateral disease, the 3-year cumulative incidence of regional/local relapse was 7.7%/4.3% after bilateral irradiation versus 16.9%/11.1% after unilateral irradiation (hazard ratio = 0.56/0.61, p = 0.17/0.32). The cumulative incidence of CUP-specific deaths was 9.2% after bilateral irradiation and 15.5% after unilateral irradiation (p = 0.92). In multivariate analysis, mucosal irradiation was associated with better local control, whereas no neck dissection, ≥N2b and interruption of RT for more than 4 days were associated with poorer regional control. Toxicity was higher after bilateral irradiation (p 0.05). No positron-emission tomography-computed tomography, largest node diameter, ≥N2b, neoadjuvant chemotherapy and interruption of RT were associated with poorer cause-specific survival.Bilateral nodal irradiation yielded non-significant better nodal and mucosal control rates but was associated with higher rates of severe toxicity.

Published
2019

18. Liste des auteurs

Author

Béatrix Barry, Olivier Malard, Sylvain Morinière, Emmanuel Babin, Cécile Badoual, Bertrand Baujat, François Bidault, Guillaume de Bonnecaze, Alexandre Bozec, Philippe Céruse, Émilien Chabrillac, Dominique Chevalier, Olivier Choussy, Cindy Colombe, Christian Debry, Sophie Deneuve, Frédérique Dubrulle, Agnès Dupret-Bories, Florent Espitalier, Nicolas Fakhry, Léa Fath, Marie Gavid, Joanne Guerlain, Sophie Guiquerro, Natacha Heutte, François Janot, Franck Jégoux, Jean Lacau Saint-Guily, Ollivier Laccourreye, Audrey Lasne-Cardon, Charles Lépine, Marine Lombard, François Mouawad, Pierre Philouze, Yoann Pointreau, Jean Michel Prades, Dominique de Raucourt, Christian Adrien Righini, Frédéric Rolland, Laure Santini, Philippe Schultz, Christophe Tessier, Juliette Thariat, Sébastien Vergez, Alfred Werner, and Virginie Woisard

Published
2019

19. To exploit the 5 ‘R’ of radiobiology and unleash the 3 ‘E’ of immunoediting: ‘RE’-inventing the radiotherapy-immunotherapy combination

Author

Alain Toledano, Delphine Borchiellini, Yoann Pointreau, Cyrus Chargari, Elisabeth Daguenet, Nicolas Magné, Claire Rodriguez-Lafrasse, Jonathan Khalifa, Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Institut de Physique Nucléaire de Lyon (IPNL), Centre National de la Recherche Scientifique (CNRS)-Université Claude Bernard Lyon 1 (UCBL), and Université de Lyon-Université de Lyon-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)

Subjects
[PHYS]Physics [physics], 0303 health sciences, medicine.medical_specialty, Radiobiology, business.industry, medicine.medical_treatment, Immunotherapy, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282, 3. Good health, Radiation therapy, 03 medical and health sciences, 0302 clinical medicine, Oncology, Immunoediting, 030220 oncology & carcinogenesis, medicine, Medical physics, business, Letter to the Editor, 030304 developmental biology
Abstract

International audience; How radiotherapy counters immune evasion In conventional radiotherapy (RT), the relative biologic effectiveness of radiation is influenced by radiobiological determinants, the so-called ‘5Rs’: Repair, Repopulation, Redistribution, Reoxygenation, and Radiosensitivity.1 A linear-quadratic model prevails to describe the radiation response of the tumor, in which the α/β ratio is used to characterize the sensitivity of a particular tissue type to fractionation. Fractionation serves to decrease acute, and especially late, toxicity to surrounding normal tissue exposed to RT. Commonly, curative RT is delivered in daily doses of 1.8–2.2 Gy for 5–8 weeks, whereas hypofractionation is defined as a delivery of greater than 2.2 Gy per fraction. With sophisticated advances in RT technologies, delivering higher doses of RT per fraction [i.e. increased biologically effective dose (BED)] in a shorter timeframe appears a safe option. Indeed, increased BED could be achieved with larger fraction sizes relative to conventionally fractionated RT. While early radiobiological studies had found that the major mechanisms of action of radiation were related to DNA damage and subsequent cell death of dividing cells, novel insights on radiation effects have uncovered the immunomodulatory properties of ionizing radiation.2

Published
2020

20. Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients

Author

Olivier Molinier, Jaafar Bennouna, N. Pourel, Hugues Bourgeois, Philippe Solal-Celigny, Fabrice Denis, Claude El Khouri, Anne-Lise Septans, P. Trémolières, Alexandre Charron, Sébastien Landry, Hélène Senellart, Yoann Pointreau, T. Lizée, Claire Lethrosne, Christophe Letellier, Magali Balavoine, Thierry Urban, Julien Domont, Centre Jean Bernard [Institut Inter-régional de Cancérologie - Le Mans], Centre René Gauducheau, CRLCC René Gauducheau, Institut de Cancérologie de l'Ouest [Angers/Nantes] (UNICANCER/ICO), UNICANCER, Complexe de recherche interprofessionnel en aérothermochimie (CORIA), Centre National de la Recherche Scientifique (CNRS)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut national des sciences appliquées Rouen Normandie (INSA Rouen Normandie), and Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Time Factors, Kaplan-Meier Estimate, law.invention, 03 medical and health sciences, Diagnostic Self Evaluation, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Outcome Assessment, Health Care, medicine, Humans, 030212 general & internal medicine, Prospective Studies, [PHYS.MECA.MEFL]Physics [physics]/Mechanics [physics]/Fluid mechanics [physics.class-ph], Prospective cohort study, Lung cancer, Aged, Neoplasm Staging, Aged, 80 and over, Internet, Chi-Square Distribution, Performance status, business.industry, Random assignment, Hazard ratio, Middle Aged, medicine.disease, Confidence interval, 3. Good health, Surgery, Clinical trial, Oncology, 030220 oncology & carcinogenesis, Population Surveillance, Quality of Life, Female, Self Report, business, Follow-Up Studies
Abstract

WOS:000410799200009; International audience; Background: The use of web-based monitoring for lung cancer patients is growing in interest because of promising recent results suggesting improvement in cancer and resource utilization outcomes. It remains an open question whether the overall survival (OS) in these patients could be improved by using a web-mediated follow-up rather than classical scheduled follow-up and imaging. Methods: Advanced-stage lung cancer patients without evidence of disease progression after or during initial treatment were randomly assigned in a multicenter phase III trial to compare a web-mediated follow-up algorithm (experimental arm), based on weekly self-scored patient symptoms, with routine follow-up with CT scans scheduled every three to six months according to the disease stage (control arm). In the experimental arm, an alert email was automatically sent to the oncologist when self-scored symptoms matched predefined criteria. The primary outcome was OS. Results: From June 2014 to January 2016, 133 patients were enrolled and 121 were retained in the intent-to-treat analysis; 12 deemed ineligible after random assignment were not subsequently followed. Most of the patients (95.1%) had stage III or IV disease. The median follow-up was nine months. The median OS was 19.0 months (95% confidence interval [CI] = 12.5 to non-calculable) in the experimental and 12.0 months (95% CI = 8.6 to 16.4) in the control arm (one-sided P = .001) (hazard ratio = 0.32, 95% CI = 0.15 to 0.67, one-sided P = .002). The performance status at first detected relapse was 0 to 1 for 75.9% of the patients in the experimental arm and for 32.5% of those in the control arm (two-sided P \textless .001). Optimal treatment was initiated in 72.4% of the patients in the experimental arm and in 32.5% of those in the control arm (two-sided P \textless .001). Conclusions: A web-mediated follow-up algorithm based on self-reported symptoms improved OS due to early relapse detection and better performance status at relapse.

Published
2017

21. Long-Term Results of a Multicenter Randomized Phase III Trial of Induction Chemotherapy With Cisplatin, 5-fluorouracil, ± Docetaxel for Larynx Preservation

Author

Marc Alfonsi, Christian Sire, Yoann Pointreau, Pascal Garaud, Eric Jadaud, Sophie Chapet, G. Janoray, and Gilles Calais

Subjects
Male, 0301 basic medicine, Larynx, Cancer Research, Time Factors, medicine.medical_treatment, Docetaxel, Kaplan-Meier Estimate, Gastroenterology, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Induction Chemotherapy, Middle Aged, Laryngectomy, Treatment Outcome, medicine.anatomical_structure, Oncology, Chemotherapy, Adjuvant, Head and Neck Neoplasms, Fluorouracil, 030220 oncology & carcinogenesis, Carcinoma, Squamous Cell, Female, Taxoids, medicine.drug, Adult, medicine.medical_specialty, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Internal medicine, TPF Regimen, medicine, Humans, Laryngeal Neoplasms, Aged, Neoplasm Staging, Chemotherapy, Hypopharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck, business.industry, Induction chemotherapy, Surgery, Radiation therapy, 030104 developmental biology, Cisplatin, business, Organ Sparing Treatments, Follow-Up Studies
Abstract

Background The purpose of GORTEC 2000-01 was to compare the long-term efficacy and safety of induction chemotherapy with cisplatin (P) and 5-fluorouracil (F) with or without docetaxel (T) for larynx preservation. Methods Operable patients with untreated stage III or IV larynx or hypopharynx invasive squamous cell carcinoma who required total laryngectomy were randomly assigned to three cycles of induction chemotherapy with either TPF or PF, followed by radiation therapy for responders. The primary endpoint was three-year larynx preservation rate. Secondary endpoints included larynx dysfunction-free survival (LDFFS), overall survival (OS), disease-free survival (DFS), loco-regional control rate (LCR), cause of death, and later toxicity rates. Survival and other data were analyzed by Kaplan-Meier methods. All statistical tests were two-sided. Results Two hundred thirteen patients were treated with median follow-up of 105 months. The five- and 10-year larynx preservation rates were 74.0% (95% CI = 0.64 to 0.82) vs 58.1% (95% CI = 0.47 to 0.68) and 70.3% (95% CI = 0.58 to 0.8) vs 46.5% (95% CI = 0.31 to 0.63, P = .01) in the TPF vs PF arm, respectively. The five- and 10-year LDFFS rates were 67.2% (95% CI = 0.57 to 0.76) vs 46.5% (95% CI = 0.36 to 0.57) and 63.7% (95% CI = 0.52 to 0.74) vs 37.2% (95% CI = 0.24 to 0.52, P = .001), respectively. OS, DFS, and LCR were not statistically improved in the TPF vs the PF arm. Statistically fewer grade 3-4 late toxicities of the larynx occurred with the TPF regimen compared with the PF arm (9.3% vs 17.1%, G-test, P = .038). Conclusion Long-term follow-up confirms that induction chemotherapy with TPF increased larynx preservation and larynx dysfunction-free survival. In this larynx preservation approach using induction chemotherapy, TPF should be recommended, followed by radiation therapy.

Published
2015

22. Segmentation automatique des images pour la planification dosimétrique en radiothérapie

Author

G. Bera, F. Denis, David Pasquier, Eric Lartigau, Laurent Peyrodie, Yoann Pointreau, Centre Galilée (Centre Galilée), Polyclinique de Louvière, LAGIS-SI, Laboratoire d'Automatique, Génie Informatique et Signal (LAGIS), Université de Lille, Sciences et Technologies-Centrale Lille-Centre National de la Recherche Scientifique (CNRS)-Université de Lille, Sciences et Technologies-Centrale Lille-Centre National de la Recherche Scientifique (CNRS), Centre Jean Bernard [Institut Inter-régional de Cancérologie - Le Mans], Centre Henry-S-Kaplan (Centre Henry-S-Kaplan), CHU Bretonneau, Département universitaire de radiothérapie, and Université de Lille, Droit et Santé

Subjects
Computer science, business.industry, Image processing, Context (language use), Conformal radiotherapy, Image segmentation, image radiothérapie, 030218 nuclear medicine & medical imaging, 03 medical and health sciences, 0302 clinical medicine, [INFO.INFO-TS]Computer Science [cs]/Signal and Image Processing, Oncology, 030220 oncology & carcinogenesis, Radiology, Nuclear Medicine and imaging, Computer vision, Artificial intelligence, business, [SPI.SIGNAL]Engineering Sciences [physics]/Signal and Image processing
Abstract

International audience; L'essor de la radiothérapie conformationnelle et de la radiothérapie guidée par l'image a pour corollaire l'accroissement du temps consacré à la délinéation des volumes d'intérêt, qui est également le siège d'une variabilité inter et intraobservateur. Les développements informatiques et du traitement d'images ont permis des progrès dans l'automatisation partielle ou totale de ces tâches. Cet article détaille les grands principes de la segmentation d'images appliquée à la radiothérapie, ses applications ainsi que ses résultats les plus récents dans un contexte clinique.

Published
2010

25. Fatal infusion reactions to cetuximab: role of immunoglobulin e-mediated anaphylaxis

Author

Hervé Watier, Scott P. Commins, Thomas A.E. Platts-Mills, Gilles Calais, and Yoann Pointreau

Subjects
Male, Cancer Research, Cetuximab, biology, business.industry, Colorectal cancer, Head and neck cancer, Antibodies, Monoclonal, Context (language use), Antineoplastic Agents, medicine.disease, Immunoglobulin E, Atopy, Oncology, Immunology, Colonic Neoplasms, biology.protein, Medicine, Humans, Antibody, business, Anaphylaxis, medicine.drug
Abstract

report a fatal hypersensitivity reaction to cetuximab in a 63-year-old patient with metastatic colon cancer and outlined a 0.1% incidence of death in the literature. We greatly acknowledge the authors’ desire to communicate the risk of fatal anaphylactic reaction with cetuximab. Over the past 2 years in our center in Tours, France, four instances of grade 4 anaphylactic reactions occurred in patients treated for head and neck cancer (locally advanced or metastatic), with one immediately fatal; another patient died within 5 days (unpublished data). Seven lethal anaphylactic reactions were registered in a pharmacovigilance survey in France, based on spontaneous declarations (Grandvuillemin et al, manuscript in preparation). Anaphylaxis to cetuximab is a problem that merits serious clinical attention. In the authors’ words, “the pathogenic mechanisms underlying the development of this phenomenon remain to be elucidated.” 1 They raise the hypothesis of immunoglobulin E (IgE) –independent mechanisms, even in the context of a paradoxic atopic history. Moreover, Tronconi et al suggest that the field “search for reliable risk factors that can facilitate the safe selection of patients as candidates for cetuximabbased treatment.” 1 These comments are quite surprising, because they do not integrate major contributions that have been previously published. Indeed, it has been known for 3 years that anaphylaxis to cetuximab is the result of antidrug IgE antibodies present in patient serum before therapy. 2 These IgE antibodies are directed against galactose--1, 3-galactose (3Gal) residues, present in the Fab portion of this monoclonal antibody. 3 Because humans do not express this glycan, anti3Gal IgM and IgG antibodies spontaneously develop, whereas the appearance of IgE is only occasional. The observation that most of the patients developed reactions to cetuximab during their first infusion supports this hypothesis and is consistent with an IgE-mediated event. Environmental factors, such as bites by ectoparasitic ticks, probably explain the heterogeneous proportion of individuals displaying anti3Gal IgE and the heterogeneous incidence of anaphylactic reactions to cetuximab among studies and geographic areas. 2,4-6 History of atopy, age, race, additional therapy (ie, chemotherapy or radiotherapy), sex, and head and neck cancer (rather than colorectal cancer) have also been proposed as factors favoring anaphylaxis to cetuximab, but they remain controversial. 2,4,5

Published
2011

26. Delineation in thoracic oncology: a prospective study of the effect of training on contour variability and dosimetric consequences

Author

Jean-Emmanuel Bibault, Pierre Blanchard, Philippe Giraud, Michel Brauner, Yoann Pointreau, Claire Vautravers-Dewas, Sylvain Dewas, and Fabrice Denis

Subjects
lcsh:Medical physics. Medical radiology. Nuclear medicine, Male, Lung Neoplasms, medicine.medical_treatment, lcsh:R895-920, volume delineation, Medical Oncology, lcsh:RC254-282, Thoracic Oncology, Carcinoma, Non-Small-Cell Lung, medicine, Humans, Radiology, Nuclear Medicine and imaging, Right upper lobe, Prospective Studies, Prospective cohort study, Radiation treatment planning, Lung cancer, Radiometry, Aged, Observer Variation, education, inter-observer variability, business.industry, Radiotherapy Planning, Computer-Assisted, Research, Significant difference, Carcinoma, respiratory system, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Radiation therapy, Oncology, Radiology Nuclear Medicine and imaging, Education, Medical, Graduate, Radiography, Thoracic, Non small cell, France, Nuclear medicine, business, Radiology, conformal radiotherapy, Algorithms
Abstract

Introduction As part of French residents' radiotherapy training, delineation workstations were available at a national teaching course. We report a prospective comparative study of a non small cell lung cancer (NSCLC) case delineated by 120 residents before and after a radioanatomy/radiotherapy lecture. Materials and methods The case of a patient with right upper lobe non small cell lung cancer (NSCLC) was provided for delineation to 32 groups of residents before and after a radiation therapy lecture about thoracic delineation. GTV, CTV and PTV was asked to each group. In a second step, the GTV, CTV and PTV were compared with those of 9 groups of senior physicians. Finally the consequences for treatment planning between each group before and after the course were explored. Results The expert's average GTV, CTV and PTV were 89.1 cm3, 242.3 cm3 and 293.9 cm3 respectively. For residents, those volumes were 103.4 cm3, 242.3 cm3 and 457.9 cm3 before teaching, compared to 99.5 cm3, 224.2 cm3 and 412.5 cm3 after teaching. The overlap (OV) and kappa (KI) indices before and after education were respectively 0.58 and 0.73. Compared to senior physicians, OV and KI indices were lower in the residents group (p = 0.039 and p = 0.043). An increased dose to the lung is noted for the residents' dosimetry compared to the experts' (V20: 23.2% versus 36.5%) due to the larger PTV delineated. No significant difference was observed for other organs at risk. Conclusion There were no significant differences for the delineation of the GTV and CTV before and after the course, although the differences tended to decrease after the course. The good initial quality of the contours could explain the lack of difference. V20 for lung was higher in the residents group compared to the experts group (23.2% vs 36.5%). No other treatment planning consequences were observed for other critical organs.

Published
2011

27. A Rare Case of Radiation-Induced Osteosarcoma of the Ethmoid Sinus

Author

David Bakhos, Alain Robier, Yoann Pointreau, and Musaed Alzahrani

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, medicine.medical_treatment, Magnetic resonance imaging, Radiation induced, Case Report, General Medicine, medicine.disease, lcsh:Otorhinolaryngology, lcsh:RF1-547, Surgery, Radiation therapy, medicine.anatomical_structure, Ethmoid sinus, Radiological weapon, Rare case, Biopsy, medicine, otorhinolaryngologic diseases, Osteosarcoma, Radiology, business
Abstract

Radiation therapy has been recognized as a useful modality of treatment in head and neck malignant tumors. However, radiation over 10 Gy may predispose to secondary tumors. Radiation-induced osteosarcoma of the ethmoid sinus is unusual. These tumors may present long after radiation with epistaxis. Computed tomography, magnetic resonance imaging, and biopsy are the modalities of diagnosis. We report a case of radiation-induced osteosarcoma of the ethmoid sinus 9 years after initial exposure. We describe the clinical presentation, the radiological findings, and the management.

Published
2011

28. Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation

Author

Jacques Tortochaux, Yoann Pointreau, Marc Alfonsi, Gilles Calais, Sophie Chapet, C. Tuchais, Christian Sire, Sandrine Faivre, Pascal Garaud, and Stephane Guerrif

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, Laryngectomy, Docetaxel, Gastroenterology, Young Adult, Internal medicine, TPF Regimen, Antineoplastic Combined Chemotherapy Protocols, otorhinolaryngologic diseases, medicine, Humans, Karnofsky Performance Status, Laryngeal Neoplasms, Aged, Chemotherapy, Hypopharyngeal Neoplasms, business.industry, Remission Induction, Induction chemotherapy, Middle Aged, medicine.disease, Chemotherapy regimen, Neoadjuvant Therapy, Surgery, stomatognathic diseases, Treatment Outcome, Oncology, Chemotherapy, Adjuvant, Carcinoma, Squamous Cell, Female, Radiotherapy, Adjuvant, Taxoids, Fluorouracil, Cisplatin, PF Regimen, business, Febrile neutropenia, medicine.drug
Abstract

BACKGROUND Chemotherapy with cisplatin (P) and 5-fluorouracil (F) followed by radiotherapy in patients who respond to chemotherapy is an alternative to total laryngectomy for patients with locally advanced larynx and hypopharynx cancer. Data suggest that docetaxel (T) may add to the efficacy of PF. The objective of this trial was to determine whether adding T to PF could increase the larynx preservation rate. METHODS Patients who had larynx and hypopharynx cancer that required total laryngectomy were randomly assigned to receive three cycles of TPF or PF. Patients who responded to chemotherapy received radiotherapy with or without additional chemotherapy. Patients who did not respond to chemotherapy underwent total laryngectomy followed by radiotherapy with or without additional chemotherapy. The primary endpoint was 3-year larynx preservation rate. Secondary endpoints included acute toxicities and overall response. All statistical tests were two-sided. RESULTS Baseline patient and tumor characteristics were well balanced between the TPF (n = 110) and PF (n = 103) groups. With a median follow-up of 36 months, the 3-year actuarial larynx preservation rate was 70.3% with TPF vs 57.5% with PF (difference = 12.8%; P = .03). Patients in the TPF group had more grade 2 alopecia, grade 4 neutropenia, and febrile neutropenia, whereas patients in the PF group had more grade 3 and 4 stomatitis, thrombocytopenia, and grade 4 creatinine elevation. The overall response was 80.0% in the TPF group vs 59.2% in the PF group (difference = 20.8%; P = .002). CONCLUSIONS In patients with advanced larynx and hypopharynx carcinomas, TPF induction chemotherapy was superior to the PF regimen in terms of overall response rate. These results suggest that larynx preservation could be achieved for a higher proportion of patients.

Published
2009

29. 8508 Preliminary results of the randomized phase II TREMPLIN study: TPF Induction chemotherapy followed by radiotherapy plus cisplatin or cetuximab

Author

Frederic Rolland, Marc Alfonsi, A. Baudoux, J.L. Lefebvre, D. De Raucourt, Gilles Calais, Christian Sire, Yoann Pointreau, C. Tuchais, and Etienne Bardet

Subjects
Oncology, Cisplatin, Cancer Research, medicine.medical_specialty, Cetuximab, business.industry, medicine.medical_treatment, Induction chemotherapy, Radiation therapy, Internal medicine, Medicine, business, medicine.drug
Published
2009

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