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Clinical Trial
. 2018 Dec 20;379(25):2395-2406.
doi: 10.1056/NEJMoa1809775.

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer

Thierry Conroy  1 , Pascal Hammel  1 , Mohamed Hebbar  1 , Meher Ben Abdelghani  1 , Alice C Wei  1 , Jean-Luc Raoul  1 , Laurence Choné  1 , Eric Francois  1 , Pascal Artru  1 , James J Biagi  1 , Thierry Lecomte  1 , Eric Assenat  1 , Roger Faroux  1 , Marc Ychou  1 , Julien Volet  1 , Alain Sauvanet  1 , Gilles Breysacher  1 , Frédéric Di Fiore  1 , Christine Cripps  1 , Petr Kavan  1 , Patrick Texereau  1 , Karine Bouhier-Leporrier  1 , Faiza Khemissa-Akouz  1 , Jean-Louis Legoux  1 , Béata Juzyna  1 , Sophie Gourgou  1 , Christopher J O'Callaghan  1 , Claire Jouffroy-Zeller  1 , Patrick Rat  1 , David Malka  1 , Florence Castan  1 , Jean-Baptiste Bachet  1 ; Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group
Collaborators, Affiliations
Clinical Trial

FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer

Thierry Conroy et al. N Engl J Med. .

Abstract

Background: Among patients with metastatic pancreatic cancer, combination chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) leads to longer overall survival than gemcitabine therapy. We compared the efficacy and safety of a modified FOLFIRINOX regimen with gemcitabine as adjuvant therapy in patients with resected pancreatic cancer.

Methods: We randomly assigned 493 patients with resected pancreatic ductal adenocarcinoma to receive a modified FOLFIRINOX regimen (oxaliplatin [85 mg per square meter of body-surface area], irinotecan [180 mg per square meter, reduced to 150 mg per square meter after a protocol-specified safety analysis], leucovorin [400 mg per square meter], and fluorouracil [2400 mg per square meter] every 2 weeks) or gemcitabine (1000 mg per square meter on days 1, 8, and 15 every 4 weeks) for 24 weeks. The primary end point was disease-free survival. Secondary end points included overall survival and safety.

Results: At a median follow-up of 33.6 months, the median disease-free survival was 21.6 months in the modified-FOLFIRINOX group and 12.8 months in the gemcitabine group (stratified hazard ratio for cancer-related event, second cancer, or death, 0.58; 95% confidence interval [CI], 0.46 to 0.73; P<0.001). The disease-free survival rate at 3 years was 39.7% in the modified-FOLFIRINOX group and 21.4% in the gemcitabine group. The median overall survival was 54.4 months in the modified-FOLFIRINOX group and 35.0 months in the gemcitabine group (stratified hazard ratio for death, 0.64; 95% CI, 0.48 to 0.86; P=0.003). The overall survival rate at 3 years was 63.4% in the modified-FOLFIRINOX group and 48.6% in the gemcitabine group. Adverse events of grade 3 or 4 occurred in 75.9% of the patients in the modified-FOLFIRINOX group and in 52.9% of those in the gemcitabine group. One patient in the gemcitabine group died from toxic effects (interstitial pneumonitis).

Conclusions: Adjuvant therapy with a modified FOLFIRINOX regimen led to significantly longer survival than gemcitabine among patients with resected pancreatic cancer, at the expense of a higher incidence of toxic effects. (Funded by R&D Unicancer and others; ClinicalTrials.gov number, NCT01526135 ; EudraCT number, 2011-002026-52 .).

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