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
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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