TY - JOUR
T1 - FOLFIRINEC
T2 - a randomized phase II trial of mFOLFIRINOX vs platinum-etoposide for metastatic neuroendocrine carcinoma of gastroenteropancreatic or unknown origin
AU - Hadoux, Julien
AU - Afchain, Pauline
AU - Walter, Thomas
AU - Tougeron, David
AU - Hautefeuille, Vincent
AU - Monterymard, Carole
AU - Lorgis, Véronique
AU - Thuillier, Frédéric
AU - Baudin, Eric
AU - Scoazec, Jean Yves
AU - Lepage, Côme
AU - Desgrippes, Romain
N1 - Publisher Copyright:
© 2021 Editrice Gastroenterologica Italiana S.r.l.
PY - 2021/7/1
Y1 - 2021/7/1
N2 - 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.
AB - 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.
KW - Chemotherapy
KW - FOLFIRINOX
KW - Gastroenteropancreatic
KW - Neuroendocrine carcinoma
UR - http://www.scopus.com/inward/record.url?scp=85105819350&partnerID=8YFLogxK
U2 - 10.1016/j.dld.2021.04.016
DO - 10.1016/j.dld.2021.04.016
M3 - Article
C2 - 33994125
AN - SCOPUS:85105819350
SN - 1590-8658
VL - 53
SP - 824
EP - 829
JO - Digestive and Liver Disease
JF - Digestive and Liver Disease
IS - 7
ER -