FOLFIRINEC: a randomized phase II trial of mFOLFIRINOX vs platinum-etoposide for metastatic neuroendocrine carcinoma of gastroenteropancreatic or unknown origin.
Adult
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Biomarkers
/ analysis
Carcinoma, Neuroendocrine
/ drug therapy
Etoposide
/ administration & dosage
Female
Fluorouracil
/ administration & dosage
Humans
Intestinal Neoplasms
/ drug therapy
Irinotecan
/ administration & dosage
Leucovorin
/ administration & dosage
Male
Neoplasm Metastasis
Neoplasms, Unknown Primary
/ drug therapy
Neuroendocrine Tumors
/ drug therapy
Oxaliplatin
/ administration & dosage
Pancreatic Neoplasms
/ drug therapy
Platinum Compounds
/ administration & dosage
Progression-Free Survival
Prospective Studies
Quality of Life
Stomach Neoplasms
/ drug therapy
Survival Rate
Treatment Outcome
Chemotherapy
FOLFIRINOX
Gastroenteropancreatic
Neuroendocrine carcinoma
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
received:
04
03
2021
revised:
11
04
2021
accepted:
12
04
2021
pubmed:
18
5
2021
medline:
2
2
2022
entrez:
17
5
2021
Statut:
ppublish
Résumé
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. 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. 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.
Sections du résumé
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.
Identifiants
pubmed: 33994125
pii: S1590-8658(21)00201-2
doi: 10.1016/j.dld.2021.04.016
pii:
doi:
Substances chimiques
Biomarkers
0
Platinum Compounds
0
folfirinox
0
Oxaliplatin
04ZR38536J
Etoposide
6PLQ3CP4P3
Irinotecan
7673326042
Leucovorin
Q573I9DVLP
Fluorouracil
U3P01618RT
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
824-829Informations de copyright
Copyright © 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest None