FOLFIRINOX or Gemcitabine as Adjuvant Therapy for Pancreatic Cancer
2 Hôpital Beaujon
3 Hôpital Claude Huriez [Lille]
4 CRLCC Paul Strauss - Centre Paul Strauss
5 IPC - Institut Paoli-Calmettes
6 Service d'Hépato-gastro-entérologie [CHRU Nancy]
7 UNICANCER/CAL - Centre de Lutte contre le Cancer Antoine Lacassagne [Nice]
8 Hôpital privé Jean Mermoz [Lyon]
9 CHRU Tours - Centre Hospitalier Régional Universitaire de Tours
10 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
11 IGMM - Institut de Génétique Moléculaire de Montpellier
12 CHD Vendée - Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
13 IRCM - U1194 Inserm - UM - Institut de Recherche en Cancérologie de Montpellier
14 CHU Reims - Hôpital universitaire Robert Debré [Reims]
15 Service de chirurgie hepato-pancreato-biliaire
16 CH Colmar - Hôpital Louis Pasteur [Colmar]
17 CHU Rouen
18 CHI Mont-de-Marsan - Centre Hospitalier Intercommunal de Mont-de-Marsan et du pays des Sources [Landes]
19 Hôpital Côte de Nacre [CHU Caen]
20 CH Perpignan - Centre Hospitalier Saint Jean de Perpignan
21 CHRO - Centre Hospitalier Régional d'Orléans
22 R&D UNICANCER
23 CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
24 Oncologie digestive [Gustave Roussy]
25 CHU Pitié-Salpêtrière [AP-HP]
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Résumé
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 .).
