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1. Crizotinib-induced osteitis mimicking bone metastasis in a stage IV ALK-rearranged NSCLC patient: a case report

Author

Nicolas Delberghe, Marie Bellefleur, Hélène Morisse-Pradier, Luc Thiberville, Mourad Ould-Slimane, Nicolas Piton, Florian Guisier, Emilie Angot, Gilles Avenel, Olivier Vittecoq, Mathieu Salaün, Service de pneumologie, oncologie thoracique et soins intensifs respiratoires [Rouen], Hôpital Charles Nicolle [Rouen]-CHU Rouen, Normandie Université (NU)-Normandie Université (NU)-Université de Rouen Normandie (UNIROUEN), Normandie Université (NU), Equipe Quantification en Imagerie Fonctionnelle (QuantIF-LITIS), Laboratoire d'Informatique, de Traitement de l'Information et des Systèmes (LITIS), Université Le Havre Normandie (ULH), Normandie Université (NU)-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)-Université Le Havre Normandie (ULH), Institut National des Sciences Appliquées (INSA)-Normandie Université (NU)-Institut National des Sciences Appliquées (INSA), Centre d'Investigation Clinique [CHU Rouen] (CIC Rouen), Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Anatomie et Cytologie Pathologique [CHU Rouen], CHU Rouen, Service de rhumatologie [CHU Rouen], Service d'orthopédie et de traumatologie [Rouen], Hôpital Charles Nicolle [Rouen], Normandie Université (NU)-Normandie Université (NU)-CHU Rouen, and Bodescot, Myriam

Subjects
ALK inhibitors, Cancer Research, Lung Neoplasms, Case Report, 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, hemic and lymphatic diseases, Anaplastic lymphoma kinase, Anaplastic Lymphoma Kinase, 030212 general & internal medicine, Sulfones, Osteitis, [SDV.MHEP.RSOA] Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, Bone metastasis, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Oncology, [SDV.MHEP.RSOA]Life Sciences [q-bio]/Human health and pathology/Rhumatology and musculoskeletal system, [SDV.SP.PHARMA] Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, 030220 oncology & carcinogenesis, Female, medicine.drug, Adult, medicine.drug_class, Antineoplastic Agents, Bone Neoplasms, [SDV.CAN]Life Sciences [q-bio]/Cancer, Ceritinib, lcsh:RC254-282, 03 medical and health sciences, Drug toxicity, [SDV.CAN] Life Sciences [q-bio]/Cancer, Crizotinib, Genetics, medicine, Humans, Lung cancer, Protein Kinase Inhibitors, ALK-rearranged NSCLC, business.industry, medicine.disease, ALK inhibitor, Pyrimidines, Tumor progression, Cancer research, [SDV.SP.PHARMA]Life Sciences [q-bio]/Pharmaceutical sciences/Pharmacology, business, Tomography, X-Ray Computed
Abstract

BackgroundTargeted therapies are a standard of care for first-line treatment of Anaplastic lymphoma kinase (ALK)-rearranged non small cell lung cancer (NSCLC). Giving the rapid pace of drug discovery and development in this area, reporting of adverse effects of ALK inhibitors is crucial. Here, we report a case of osteitis induced by an ALK inhibitor mimicking bone metastasis, a previously undescribed side effect of crizotinib.Case presentationA 31-year-old woman with stage IVALK-rearranged NSCLC presented with back pain after 3 months of crizotinib treatment. Diagnostic work-up showed osteitis on the 4th and 5th thoracic vertebrae, anterior soft tissue infiltration and epiduritis, without any sign of infection. Spinal cord decompression, histological removal and osteosynthesis were performed. Histologic examination showed necrosis with abundant peripheral neutrophils, no microorganism nor malignant cell. Symptoms and Computarized Tomography-abnormalities rapidly diseappeared after crizotinib withdrawal and did not recur after ceritinib onset.ConclusionsThis is the first report of crizotinib-induced osteitis. Crizotinib differs from other ALK inhibitors as it targets other kinases as well, which may have been responsible for the osteitis. Crizotinib can induce rapidly extensive osteitis, which can mimic tumor progression.

Published
2020

2. Sustained degradation of quality of life in a subgroup of lymphoma survivors: a two-year prospective survey

Author

Cécile Conte, Gisèle Compaci, Guy Laurent, Lucie Oberic, Fabien Despas, Loic Ysebaert, Service d'Hématologie [IUCT Toulouse], Université Fédérale Toulouse Midi-Pyrénées-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Service of Medical and Clinical Pharmacology [Toulouse], Center of Pharmacovigilance, Pharmaco-epidemiology and Information on Drugs [Toulouse], CHU Toulouse [Toulouse]-CHU Toulouse [Toulouse], Laboratoire de Pharmacologie, CHU Toulouse [Toulouse], Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Centre de Recherches en Cancérologie de Toulouse (CRCT), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), This work was supported by the National Research Agency (ANR: Agence Nationale de la Recherche) for the 'investissement d’avenir' (ANR-11-PHUC-001, CAPTOR project)., ANR-11-PHUC-0001/11-PHUC-0001,CAPTOR,Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région(2011), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), ANR-11-PHUC-0001,CAPTOR,Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région(2011), Bodescot, Myriam, Pôle hospitalier Universitaire Cancer (PHUC) - Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région - - CAPTOR2011 - ANR-11-PHUC-0001 - PHUC - VALID, Service Hématologie - IUCT-Oncopole [CHU Toulouse], Pôle Biologie [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle IUCT [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service Pharmacologie Clinique [CHU Toulouse], Pôle Santé publique et médecine publique [CHU Toulouse], and Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)

Subjects
Adult, Male, Quality of life, Cancer Research, medicine.medical_specialty, Lymphoma, Cancer survivorship, Health Status, [SDV.CAN]Life Sciences [q-bio]/Cancer, Disease, lcsh:RC254-282, 03 medical and health sciences, Young Adult, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Cancer Survivors, Risk Factors, Internal medicine, Genetics, Medicine, Humans, 030212 general & internal medicine, Prospective Studies, Risk factor, Anthracycline-based chemotherapy, Prospective cohort study, Depression (differential diagnoses), Aged, Aged, 80 and over, business.industry, Incidence (epidemiology), Lymphoma, Non-Hodgkin, Middle Aged, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Comorbidity, Hodgkin Disease, humanities, 3. Good health, Oncology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, 030220 oncology & carcinogenesis, Cohort, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Shared care model, business, Research Article
Abstract

Background Previous studies have suggested that lymphoma survivors commonly display altered Health-Related Quality of Life (HRQoL). Because these were predominantly cross-sectional studies, the dynamic of events as well as the factors which influence HRQoL remain to be determined. Methods We conducted a prospective study on a cohort of 204 Hodgkin and non-Hodgkin lymphoma survivors who remained disease-free 2 years after undergoing chemotherapy (referred to the M0-M12-M24 periods). Results We found that although Physical and Mental Component Scores (PCS and MCS) of HRQoL significantly improved from M0 to M24 in the vast majority of patients (favorable group), approximately 20% of patients displayed severe alterations in HRQoL (global SF-36 scores Conclusions Although the HRQoL of lymphoma survivors generally improved over time, persistent and severe HRQoL alterations still affected approximately one fifth of patients, resulting in important social consequences. This specific group, which presents with identifiable risk factors, may benefit from early, targeted psycho-social support.

Published
2019

3. Pap tests for cervical cancer screening test and contraception: analysis of data from the CONSTANCES cohort study

Author

Stéphanie Mignot, Virginie Ringa, Marie Zins, Solène Vigoureux, Pierre-Jean Saulnier, Henri Panjo, Xavier Fritel, Département de Médecine Générale, Université de Poitiers (DMG), Université de Poitiers - Faculté de Médecine et de Pharmacie, Université de Poitiers-Université de Poitiers, Gender, Sexuality and Health team [Villejuif], Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut national d'études démographiques (INED), Obstetrics & Gynecology Department [Le Kremlin-Bicêtre], Université Paris-Sud - Paris 11 - Faculté de médecine (UP11 UFR Médecine), Université Paris-Sud - Paris 11 (UP11)-Université Paris-Sud - Paris 11 (UP11), Cohortes épidémiologiques en population (CONSTANCES), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université Paris Cité (UPCité), Université Paris Descartes - Paris 5 (UPD5), CIC - Poitiers, Université de Poitiers-Centre hospitalier universitaire de Poitiers (CHU Poitiers)-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), The French CONSTANCES cohort is supported by the French National Research Agency (ANR-11-INBS-0002), Caisse Nationale d’Assurance Maladie des travailleurs salariés-CNAMTS, and is funded by the Institut de Recherche en Santé Publique/Institut Thématique Santé Publique, and the following sponsors: Ministère de la santé et des sports, Ministère délégué à la recherche, Institut national de la santé et de la recherche médicale, Institut national du cancer et Caisse nationale de solidarité pour l’autonomie, as well as Institute for research in public health (IReSP, CapaciT project)., ANR-11-INBS-0002,CONSTANCES,La cohorte CONSTANCES - Infrastructure épidémiologique ouverte pour la recherche et la surveillance(2011), Bodescot, Myriam, Infrastructures - La cohorte CONSTANCES - Infrastructure épidémiologique ouverte pour la recherche et la surveillance - - CONSTANCES2011 - ANR-11-INBS-0002 - INBS - VALID, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), and Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Paris (UP)

Subjects
0301 basic medicine, Cancer Research, Multivariate analysis, Cross-sectional study, Uterine Cervical Neoplasms, 0302 clinical medicine, 5. Gender equality, Mass Screening, Cervical cancer screening, Early Detection of Cancer, medicine.diagnostic_test, Obstetrics, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Contraception, Oncology, 030220 oncology & carcinogenesis, Pill, Sex life, Cohort, Female, France, Cohort study, Research Article, Papanicolaou Test, Adult, medicine.medical_specialty, [SDV.CAN]Life Sciences [q-bio]/Cancer, Adhesion to screening, Intrauterine device, lcsh:RC254-282, 03 medical and health sciences, Young Adult, [SDV.CAN] Life Sciences [q-bio]/Cancer, Genetics, medicine, Humans, Pap test, Aged, Vaginal Smears, business.industry, Patient Acceptance of Health Care, 030104 developmental biology, Cross-Sectional Studies, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, Patient Compliance, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business
Abstract

International audience; BACKGROUND:In France, a Pap test for cervical cancer screening is recommended every three years for all sexually active women aged 25 to 65 years. Modes of contraception (any or no contraception, with or without a visit to a physician, and with or without a gynecological examination) may influence adhesion to screening: women who use intrauterine device (IUD) should be more up to date with their cervical cancer screening more often than those using other means of contraception. Our objectives were to analyze the association between modes of contraception and Pap tests for screening.METHODS:This cross sectional study is based on the CONSTANCES cohort enabled us to include 16,764 women aged 25-50 years. The factors associated with adhesion to cervical cancer screening (defined by a report of a Pap test within the previous 3 years) was modeled by logistic regression. Missing data were imputed by using multiple imputations. The multivariate analyses were adjusted for sex life, social and demographic characteristics, and health status.RESULTS:Overall, 11.2% (1875) of the women reported that they were overdue for Pap test screening. In the multivariate analysis there was no significant difference between women using an IUD and those pills or implant of pap test overdue ORa:0.9 CI95% [0.8-1.1], ORa 1.3 CI95% [0.7-2.7] respectively. Women not using contraceptives and those using non-medical contraceptives (condoms, spermicides, etc.) were overdue more often ORa: 2.6 CI95% [2.2-3.0] and ORa: 1.8 CI95% [1.6-2.1] respectively than those using an IUD.CONCLUSION:Women seeing medical professionals for contraception are more likely to have Pap tests.

Published
2019

4. Phase I/IIa study of concomitant radiotherapy with olaparib and temozolomide in unresectable or partially resectable glioblastoma: OLA-TMZ-RTE-01 trial protocol

Author

Laurent Castera, William Kao, J. Lequesne, Bénédicte Clarisse, Elodie Coquan, J. Lacroix, Aurélie Capel, Marie Lange, Benoit Andre, Jean-Michel Grellard, Paul Lesueur, Anaïs Lelaidier, Julien Geffrelot, Audrey Emmanuelle Dugué, Evelyne Emery, Dinu Stefan, David Hassanein Berro, Nicolas Goardon, Angélique Léger, Alexandra Leconte, Pierre-Emmanuel Brachet, Université de Caen Normandie (UNICAEN), Normandie Université (NU), Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), Centre de recherche clinique [CHU Caen] (CRC), Normandie Université (NU)-Normandie Université (NU)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Service de Neurochirurgie [CHU Caen], Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Unité de recherche interdisciplinaire pour la prévention et le traitement des cancers (ANTICIPE), Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Pharmacie [Baclesse Caen], UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), This trial (NCT03212742) is granted by the French Cancer Institute and French Health Ministry (PHRC-K15–135). Astra-Zeneca provided olaparib. Olaparib is provided free of charge to enrolled patients by Astra Zeneca., and Bodescot, Myriam

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Radiosensitizer, medicine.medical_treatment, [SDV.CAN]Life Sciences [q-bio]/Cancer, Poly(ADP-ribose) Polymerase Inhibitors, olaparib, lcsh:RC254-282, Piperazines, Olaparib, 03 medical and health sciences, chemistry.chemical_compound, Study Protocol, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Surgical oncology, Internal medicine, Biopsy, Genetics, medicine, Temozolomide, Humans, Antineoplastic Agents, Alkylating, Chemotherapy, medicine.diagnostic_test, Radiotherapy, business.industry, Brain Neoplasms, Chemoradiotherapy, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Radiation therapy, Radiosensitizer, olaparib, 030104 developmental biology, chemistry, Poly (ADP-ribose) polymerase (PARP), 030220 oncology & carcinogenesis, Concomitant, Phthalazines, Radiotherapy, Intensity-Modulated, business, Glioblastoma, medicine.drug
Abstract

International audience; BACKGROUND:Despite multimodality treatments including neurosurgery, radiotherapy and chemotherapy, glioblastoma (GBM) prognosis remains poor. GBM is classically considered as a radioresistant tumor, because of its high local recurrence rate, inside the irradiation field. The development of new radiosensitizer is crucial to improve the patient outcomes. Pre-clinical data showed that Poly (ADP-ribose) polymerase inhibitors (PARPi) could be considered as a promising class of radiosensitizer. The aim of this study is to evaluate Olaparib, a PARPi, as radiosensitizing agent, combined with the Stupp protocol, namely temozolomide (TMZ) and intensity modulated radiotherapy (IMRT) in first line treatment of partially or non-resected GBM.METHODS:The OLA-TMZ-RTE-01 study is a multicenter non-randomized phase I/IIa trial including unresectable or partially resectable GBM patients, from 18 to 70 years old. A two-step dose-escalation phase I design will first determine the recommended phase 2 dose (RP2D) of olaparib, delivered concomitantly with TMZ plus conventional irradiation for 6 weeks and as single agent for 4 weeks (radiotherapy period), and second, the RP2D of olaparib combined with adjuvant TMZ (maintenance period). Phase IIa will assess the 18-month overall survival (OS) of this combination. In both phase I and IIa separately considered, the progression-free survival, the objective response rate, the neurocognitive functions of patients, emotional disorders among caregivers, the survival without toxicity, degradation nor progression, the complications onset and the morphologic and functional MRI (magnetic resonance imaging) parameters will be also assessed as secondary objectives. Ancillary objectives will explore alteration of the DNA repair pathways on biopsy tumor, proton magnetic resonance spectroscopy parameters to differentiate tumor relapse and radionecrosis, and an expanded cognition evaluation. Up to 79 patients will be enrolled: 30 patients in the phase I and 49 patients in the phase IIa.DISCUSSION:Combining PARP inhibitors, such as olaparib, with radiotherapy and chemotherapy in GBM may improve survival outcomes, while sparing healthy tissue and preserving neurocognitive function, given the replication-dependent efficacy of olaparib, and the increased PARP expression in GBM as compared to non-neoplastic brain tissue. Ancillary studies will help to identify genetic biomarkers predictive of PARPi efficacy as radiosensitizer.TRIAL REGISTRATION:NCT03212742 , registered June, 7, 2017. Protocol version: Version 2.2 dated from 2017/08/18.

Published
2019

5. A retrospective study of patient-tailored FOLFIRINOX as a first-line chemotherapy for patients with advanced biliary tract cancer

Author

Gabriella Pittau, Pamela Biondani, Wathek Almohamad, Ayhan Ulusakarya, Abdoulaye Karaboué, Oriana Ciacio, Mazen Haydar, Yusuf Gumus, Amale Chebib, Pasquale F. Innominato, Department of Medical Oncology [Villejuif], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse, Modèles de Cellules Souches Malignes et Thérapeutiques, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Sud - Paris 11 (UP11), Medical oncology unit [Montfermeil], Groupe Hospitalier Intercommunal Le Raincy-Montfermeil, Department of Surgery [Villejuif], Betsi Cadwaladr University Health Board [Bangor, Royaume-Uni], Warwick Medical School, University of Warwick [Coventry], Université Paris-Sud - Paris 11 (UP11)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Bodescot, Myriam

Subjects
Male, Cancer Research, FOLFIRINOX, Advanced biliary tract cancer, Leucovorin, Real life practice, Gastroenterology, Cholangiocarcinoma, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Aged, 80 and over, 0303 health sciences, Middle Aged, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, [SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences, Oxaliplatin, Biliary Tract Neoplasms, medicine.anatomical_structure, Oncology, 030220 oncology & carcinogenesis, Female, Fluorouracil, France, Research Article, medicine.drug, Adult, medicine.medical_specialty, [SDV.CAN]Life Sciences [q-bio]/Cancer, Irinotecan, lcsh:RC254-282, Disease-Free Survival, 03 medical and health sciences, [SDV.CAN] Life Sciences [q-bio]/Cancer, Internal medicine, Pancreatic cancer, Genetics, medicine, Carcinoma, Humans, Response Evaluation Criteria in Solid Tumors, Aged, Neoplasm Staging, Retrospective Studies, 030304 developmental biology, business.industry, Gallbladder, [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Retrospective cohort study, medicine.disease, [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology, Gemcitabine, Regimen, business, Febrile neutropenia
Abstract

Background FOLFIRINOX is a pillar first-line regimen in the treatment of pancreatic cancer. Historically, biliary tract cancer (BTC) and pancreatic cancer have been treated similarly with gemcitabine alone or combined with a platinum compound. With growing evidence supporting the role of fluoropyrimidines in the treatment of BTC, we aimed at assessing the outcomes of patients (pts) with BTC on frontline FOLFIRINOX. Methods We retrospectively analyzed data of all our consecutive patients with locally advanced (LA) or metastatic (M) BTC who were registered to receive FOLFIRINOX as a first-line therapy between 12/2013 and 11/2017 at Paul Brousse university hospital. The main endpoints were Overall Survival (OS), Time-to-Progression (TTP), best Objective Response Rate (ORR), Disease Control rate (DCR), secondary macroscopically-complete resection (res) and incidence of severe (grade 3–4) toxicity (tox). Results There were 17 male (40%) and 25 female (60%) pts. aged 36 to 84 years (median: 67). They had PS of 0 (55%) or 1 (45%), and intrahepatic cholangiocarcinoma (CCA) (21 pts., 50%), gallbladder carcinoma (8 pts., 19%), perihilar CCA (7 pts., 17%), distal CCA (4 pts., 10%) and ampulloma (2 pts., 5%). BTC was LA or M in 10 (24%) and 32 pts. (76%) respectively. Biliary stent was placed in 14 pts. (33%). A median of 10 courses was given with median treatment duration of 6 months. There were no untoward toxicity issues, with no febrile neutropenia, emergency admission for toxicity or toxic death. We observed 12 partial responses (29%) and 19 disease stabilisations (45%). Six patients (14%) underwent secondary R0-R1 resection. Median TTP was 8 months [95%CL, 6–10] and median OS was 15 months [13–17]. Patients undergoing secondary resection displayed a 3-y disease-free rate of 83%. Conclusions First-line FOLFIRINOX offers promising results in patients with LA and M-BTC. It deserves prospective evaluation to further improve outcomes for advanced BTC.

Published
2020

6. Improving communication between the general practitioner and the oncologist: a key role in coordinating care for patients suffering from cancer

Author

Vladimir Druel, K. Paricaud, Laëtitia Gimenez, Jean-Pierre Delord, Pascale Grosclaude, Nathalie Boussier, Marie-Eve Rougé Bugat, Bodescot, Myriam, Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Oncology Unit [Auch], Centre Hospitalier d'Auch (CH Auch), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées, Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps (LEASP), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Service Médecine interne [CHU Toulouse], Pôle Inflammation, infection, immunologie et loco-moteur [CHU Toulouse] (Pôle I3LM Toulouse), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), 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), Réseau régional de cancérologie Onco-Occitanie, 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)-Université Toulouse III - Paul Sabatier (UT3), Department of Primary Care [Toulouse], Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées, Department of Internal Medicine [Toulouse], CHU Toulouse [Toulouse], Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3)

Subjects
Oncology, Male, Cancer Research, medicine.medical_specialty, [SDV.CAN]Life Sciences [q-bio]/Cancer, Disclosure, lcsh:RC254-282, General practitioner, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Surgical oncology, General Practitioners, Internal medicine, Neoplasms, Genetics, Medicine, Humans, 030212 general & internal medicine, Referral and Consultation, Aged, Cancer, Oncologists, Patient Care Team, business.industry, Communication, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, 3. Good health, Cross-Sectional Studies, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, 030220 oncology & carcinogenesis, General practice, Oncologist, Day hospital, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Interdisciplinary Communication, business, Research Article
Abstract

Background Patients suffering from cancers are increasingly numerous in general practice consultations. The General Practitioner (GP) should be at the heart of the management of patients. Several studies have examined the perceptions of GPs confronted with the patient suffering from cancer and the relationships of GPs with oncologists, but few studies have focused on the patients’ perspective. We studied the three-way relationship between the oncologist, the GP, and the patient, from the patient’s point of view. Methods A questionnaire validated by a group consisting of GPs, oncologists, nurses, an epidemiologist and quality analyst, was administered over a three-week period to patients suffering from cancer receiving chemotherapy in a day hospital. Results The analysis was based on 403 questionnaires. Patients had confidence in the GP’s knowledge of oncology in 88% of cases; 49% consulted their GP for pain, 15% for cancer-related advice, and 44% in emergencies. Perceived good GP/oncologist communication led patients to turn increasingly to their GP for cancer-related consultations (RR = 1.14; p = 0.01) and gave patients confidence in the GP’s ability to manage cancer-related problems (RR = 1.30; p p p Conclusion Patients suffering from cancer considered that the GP was competent, but did not often consult their GP for cancer-related problems. There is a discrepancy between patients’ beliefs and their behaviour. When the oncologist spoke to patients of the GP’s role, patients had recourse to their GP more often. Systematically integrating a GP consultation to conclude cancer diagnosis disclosure, could improve management and care coordination.

Published
2019

7. Prognostic role of CD4 T-cell depletion after frontline fludarabine, cyclophosphamide and rituximab in chronic lymphocytic leukaemia

Author

Lucie Oberic, François Vergez, Françoise Durrieu, Elodie Martin, Michaël Pérès, Thomas Filleron, Anne Quillet Mary, Fontanet Bijou, Loic Ysebaert, Martin Gauthier, Service d'Hématologie [IUCT Toulouse], Université Fédérale Toulouse Midi-Pyrénées-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Biology and Haematology [Bordeaux], Institut Bergonié - CRLCC Bordeaux, Department of Biostatistics [Toulouse], Institut Claudius Regaud-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Department of Biology and Haematology [Toulouse], Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Department of Medical Haematology [Bordeaux], Centre de Recherches en Cancérologie de Toulouse (CRCT), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), This work was partly supported by the grant 'Investissement d’Avenir' ANR-11-PHUC-001 of the French National Research Agency., ANR: 11-PHUC-0001,CAPTOR,Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région(2011), Institut Bergonié [Bordeaux], UNICANCER-UNICANCER, Centre d'Études Linguistiques - Corpus, Discours et Sociétés (CEL), Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université de Lyon, Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Claudius Regaud, 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)-CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), ANR-11-PHUC-0001,CAPTOR,Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région(2011), Centre d'Etudes Linguistiques (CEL), Service Hématologie - IUCT-Oncopole [CHU Toulouse], Pôle Biologie [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle IUCT [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), 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)-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), Bodescot, Myriam, and Pôle hospitalier Universitaire Cancer (PHUC) - Cancer et Pharmacologie : Projet de Toulouse-Oncopole et de sa Région - - CAPTOR2011 - ANR-11-PHUC-0001 - PHUC - VALID

Subjects
CD4-Positive T-Lymphocytes, Male, 0301 basic medicine, Oncology, Cancer Research, Neoplasm, Residual, [SDV]Life Sciences [q-bio], medicine.medical_treatment, Immunoglobulin Variable Region, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Immunosuppression, Middle Aged, Prognosis, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, 3. Good health, Fludarabine, Treatment Outcome, Chronic lymphocytic Leukaemia, 030220 oncology & carcinogenesis, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, Rituximab, IGHV@, Immunosuppressive Agents, Vidarabine, Research Article, medicine.drug, medicine.medical_specialty, [SDV.IMM] Life Sciences [q-bio]/Immunology, Cyclophosphamide, [SDV.CAN]Life Sciences [q-bio]/Cancer, lcsh:RC254-282, Chemo-immunotherapy, 03 medical and health sciences, [SDV.CAN] Life Sciences [q-bio]/Cancer, CD4 T-cells, Internal medicine, Genetics, medicine, Humans, Lymphocyte Count, Surrogate endpoint, business.industry, Minimal residual disease, Leukemia, Lymphocytic, Chronic, B-Cell, Survival Analysis, 030104 developmental biology, Mutation, business, CD8, Follow-Up Studies
Abstract

International audience; BACKGROUND:Eradication of minimal residual disease (MRD), at the end of Fludarabine-Cyclophosphamide-Rituximab (FCR) treatment, is a validated surrogate marker for progression-free and overall survival in chronic lymphocytic leukaemia. But such deep responses are also associated with severe immuno-depletion, leading to infections and the development of secondary cancers.METHODS:We assessed, blood MRD and normal immune cell levels at the end of treatment, in 162 first-line FCR patients, and analysed survival and adverse event.RESULTS:Multivariate Landmark analysis 3 months after FCR completion identified unmutated IGHV status (HR, 2.03, p = 0.043), the level of MRD reached (intermediate versus low, HR, 2.43, p = 0.002; high versus low, HR, 4.56, p = 0.002) and CD4 > 200/mm3 (HR, 3.30, p

Published
2019

8. Health-related quality of life as an endpoint in oncology phase I trials: a systematic review

Author

Amélie Anota, Ahmad Ousmen, Franck Bonnetain, Isabelle Le Ray, Nicolas Isambert, Frédéric Fiteni, Department of Medical Oncology [Nîmes], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Université de Montpellier (UM), Department of Neonatology [Strasbourg], CHU Strasbourg, Department of Medical Epidemiology and Biostatistics (MEB), Karolinska Institutet [Stockholm], Unité de Méthodologie et de Qualité de Vie en Cancérologie (UMQVC), Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (EA 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Université de Franche-Comté (UFC), Université Bourgogne Franche-Comté [COMUE] (UBFC)-Université Bourgogne Franche-Comté [COMUE] (UBFC)-Pôle cancérologie (CHRU Besançon), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Institut Régional Fédératif du Cancer (IRFC), Département d'oncologie médicale [Centre Georges-François Leclerc], Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER-UNICANCER, French National Platform Quality of Life and Cancer [Dijon], Bodescot, Myriam, Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181) (CEF2P / CARCINO), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon)-Institut Régional Fédératif du Cancer (IRFC), and Plateforme nationale qualité de vie et cancer

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Health-related quality of life, [SDV.CAN]Life Sciences [q-bio]/Cancer, lcsh:RC254-282, Phase I trial, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Quality of life, Surgical oncology, Neoplasms, Surveys and Questionnaires, Internal medicine, Outcome Assessment, Health Care, Recommended phase II dose, Genetics, medicine, Humans, Adverse effect, Neoplasm Staging, Health related quality of life, Clinical Trials, Phase I as Topic, business.industry, Minimal clinically important difference, Repeated measures design, Common Terminology Criteria for Adverse Events, Phase i trials, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Endpoint, Combined Modality Therapy, humanities, 3. Good health, [SDV.SP] Life Sciences [q-bio]/Pharmaceutical sciences, Treatment Outcome, 030104 developmental biology, [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, 030220 oncology & carcinogenesis, Quality of Life, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, business, Research Article
Abstract

International audience; BACKGROUND:Phase I trials aim to identify the recommended dose for further development. Health-related quality of life (HRQoL) could be a complement to the usual National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale to detect adverse events and define the doses. The objective of this study is to review the phase I in oncology which used HRQoL as endpoint.METHODS:A search in PubMed database identified phase I trials in oncology with HRQoL as endpoint, published between January 2012 to May 2016. Hematological and pediatric phase I were excluded.RESULTS:A total of 1333 phase I were identified and 15 trials were identified with HRQoL as endpoint (1.1%). The European Organisation for Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was the most frequently used instrument: 5 studies (33.3%). The targeted dimensions of HRQoL and the minimal clinically important difference were prespecified in 1 study (6.7%) and 2 studies (13.3%), respectively. Twelve studies (80%) described the statistical approach to analyze HRQoL data. Eight studies used the mean change from baseline (60%) to analyse longitudinal HRQoL data, two the mean score at certain times (13.3%), one the linear mixed model for repeated measures (6.7%), one the time to HRQoL score deterioration (6.7%), one percentage of patient-reported symptoms (6.7%). None of the studies used HRQoL to determine the recommended doses.CONCLUSION:Few phase I studies used HRQoL as endpoint and among studies with HRQoL as endpoint, the methodology of HRQoL measurement and statistical analysis was heterogeneous. HRQoL. endpoint not used for assessing the recommended phase II doses.

Published
2019

9. Patients’ quality of life during active cancer treatment: a qualitative study

Author

Jordan Sibeoni, Guilhem Bousquet, Massimiliano Orri, Anne Revah-Levy, Laurence Verneuil, Mathilde Labey, Camille Picard, Equipe 2 : ECSTRA - Epidémiologie Clinique, STatistique, pour la Recherche en Santé (CRESS - U1153), Université Paris Diderot - Paris 7 (UPD7)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Service de Dermatologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Normandie Université (NU), Douglas Mental Health University Institute [Montréal], McGill University, Hôpital Avicenne, Université Paris 13 (UP13), The study was supported by Grant No. 00050334 from the Fondation de France, 'Soigner, soulager, accompagner' 2014., McGill University = Université McGill [Montréal, Canada], Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), and Bodescot, Myriam

Subjects
Quality of life, Adult, Male, Cancer Research, medicine.medical_specialty, media_common.quotation_subject, Physician-patient relationship, [SDV.CAN]Life Sciences [q-bio]/Cancer, Care, lcsh:RC254-282, 03 medical and health sciences, Interpersonal relationship, 0302 clinical medicine, Quality of life (healthcare), [SDV.CAN] Life Sciences [q-bio]/Cancer, Qualitative research, Neoplasms, Health care, Genetics, Medicine, Humans, Quality (business), Interpersonal Relations, 030212 general & internal medicine, Recreation, media_common, Aged, Physician-Patient Relations, business.industry, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Object (philosophy), 3. Good health, Oncology, 030220 oncology & carcinogenesis, Family medicine, Female, Thematic analysis, business, Research Article
Abstract

International audience; BACKGROUND: Patients' quality of life has become a major objective of care in oncology. At the same time, it has become the object of increasing interest by researchers, working with both quantitative and qualitative methods. Progress in oncology has enabled more patients to survive longer, so that cancer is increasingly often a chronic disease that requires long-term treatment that can have negative effects on patients' quality of daily life. Nonetheless, no qualitative study has explored what patients report affects their quality of daily life during the treatment period. This study is intended to fill this gap.METHODS: We conducted a multicenter qualitative study based on 30 semi-structured interviews. Participants, purposively selected until data saturation, had diverse types of cancer and had started treatment at least 6 months before interview. Data were examined by thematic analysis.RESULTS: Our analysis found two themes: (1) what negatively affected for patient's quality of daily life during the treatment period, a question to which patients responded by talking only about the side effects of treatment; and (2) what positively affected their quality of daily life during the treatment period with three sub-themes: (i) The interest in having -investing in - a support object that can be defined as an object, a relationship or an activity particularly invested by the patients which makes them feel good and makes the cancer and its treatment bearable, (ii)The subjective perception of the efficacy of the antitumor treatment and (iii) the positive effects of relationships, with friends and family, and also with their physician.CONCLUSIONS: Patients must be involved in their care if they are to be able to bear their course of treatment and find ways to endure the difficult experience of cancer care. The support object represents an important therapeutic lever that can be used by their oncologists. They should be interested in their support objects, in order to support the patients in this investment and to help them to maintain it throughout the health care pathway. Furthermore, showing interest in this topic, important to the patient, could improve the physician-patient relation without using up very much of the physician's time.

Published
2018

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