FOLFIRINEC: a randomized phase II trial of mFOLFIRINOX vs platinum-etoposide for metastatic neuroendocrine carcinoma of gastroenteropancreatic or unknown origin

Julien Hadoux, Pauline Afchain, Thomas Walter, David Tougeron, Vincent Hautefeuille, Carole Monterymard, Véronique Lorgis, Frédéric Thuillier, Eric Baudin, Jean Yves Scoazec, Côme Lepage, Romain Desgrippes

    Résultats de recherche: Contribution à un journalArticleRevue par des pairs

    14 Citations (Scopus)

    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.

    langue originaleAnglais
    Pages (de - à)824-829
    Nombre de pages6
    journalDigestive and Liver Disease
    Volume53
    Numéro de publication7
    Les DOIs
    étatPublié - 1 juil. 2021

    Contient cette citation