FOLFIRINEC: a randomized phase II trial of mFOLFIRINOX vs platinum-etoposide for metastatic neuroendocrine carcinoma of gastroenteropancreatic or unknown origin
Autor: | Véronique Lorgis, Eric Baudin, Romain Desgrippes, Frédéric Thuillier, Jean-Yves Scoazec, Côme Lepage, Pauline Afchain, Thomas Walter, David Tougeron, Carole Monterymard, Vincent Hautefeuille, Julien Hadoux |
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Přispěvatelé: | Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR), Service d'Oncologie Médicale [CHU Saint -Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Hospices Civils de Lyon (HCL), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Service d'Hépato Gastroenterologie [CHU Amiens-Picardie], CHU Amiens-Picardie, 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 Georges-François Leclerc [Dijon] (UNICANCER/CRLCC-CGFL), UNICANCER, Service d'Oncologie médicale [CHU Limoges], CHU Limoges, Département de biologie et pathologie médicales [Gustave Roussy], CH de Saint-Malo [Broussais], Service d'Oncologie Médicale [CHU Saint-Antoine], CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Gestionnaire, HAL Sorbonne Université 5 |
Rok vydání: | 2021 |
Předmět: |
Oncology
Male FOLFIRINOX medicine.medical_treatment Leucovorin Phases of clinical research Platinum Compounds 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols Prospective Studies Neoplasm Metastasis Etoposide Gastroenterology Evaluable Disease Progression-Free Survival 3. Good health Oxaliplatin Survival Rate Neuroendocrine Tumors Treatment Outcome 030220 oncology & carcinogenesis Neuroendocrine carcinoma 030211 gastroenterology & hepatology Female Fluorouracil medicine.drug Adult medicine.medical_specialty Irinotecan Gastroenteropancreatic 03 medical and health sciences Stomach Neoplasms Internal medicine Intestinal Neoplasms medicine Chemotherapy Humans Contraindication Hepatology Performance status business.industry [SDV.MHEP.HEG]Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology [SDV.MHEP.HEG] Life Sciences [q-bio]/Human health and pathology/Hépatology and Gastroenterology Carcinoma Neuroendocrine Pancreatic Neoplasms Regimen Quality of Life Neoplasms Unknown Primary business Biomarkers |
Zdroj: | Digestive and Liver Disease Digestive and Liver Disease, WB Saunders, 2021, 53 (7), pp.824-829. ⟨10.1016/j.dld.2021.04.016⟩ Digestive and Liver Disease, 2021, 53 (7), pp.824-829. ⟨10.1016/j.dld.2021.04.016⟩ |
ISSN: | 1878-3562 1590-8658 |
Popis: | Background Poorly differentiated neuroendocrine carcinomas (NEC) are rare diseases with a poor prognosis. Platinum-etoposide (PE) has been the recommended first-line treatment for decades. FOLFIRINEC (NCT04325425) is a national multicenter randomized phase II study which aims to challenge this standard regimen. Methods The primary objective is to compare the median progression-free survival (PFS) under mFOLFIRINOX versus PE. The secondary objectives are to evaluate the objective response rates (ORR), median overall survival (OS), safety and quality of life. The associated real-time translational study will establish a molecular profile for each patient enrolled. Main inclusion criteria are NEC of gastroenteropancreatic (GEP) or unknown origin, metastatic and RECIST 1.1 evaluable disease, tumor sample available and no contraindication to chemotherapy. Patients will be randomized 1:1 between PE every 21 days for 6–8 cycles and mFOLFIRINOX every 14 days for up to 12 cycles and stratified according to center, performance status, Ki67 and pathological subtype. This trial will randomize 218 patients (24 months of follow-up) to have 80% power to detect an improvement of the median PFS from 5 months under PE to 7.5 months under mFOLFIRINOX (HR of 0.67, α =5%, two-sided). An intermediate analysis is planned at 50% of events. Recruitment started on October 20, 2020. |
Databáze: | OpenAIRE |
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