617PDA PHASE III TRIAL COMPARING FOLFIRINOX VERSUS GEMCITABINE FOR METASTATIC PANCREATIC CANCER

Abstract Aim: There is paucity of data comparing the efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) versus gemcitabine as first-line therapy in patients with metastatic pancreatic cancer. Methods: We randomly assigned 310 patients with an Eastern Cooperative Oncology Group performance status score of 0 or 1 (on a scale of 0 to 5) to receive FOLFIRINOX (oxaliplatin, 85 mg per square meter of body-surface area; irinotecan, 180 mg per square meter; leucovorin, 400 mg per square meter; and fluorouracil, 400 mg per square meter given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks) or gemcitabine at a dose of 1000 mg per square meter on Day 1, 8 and 15, cycle repeated at 28 days for 6 cycles. Six months of chemotherapy were recommended in both groups in patients who had a response. The primary end point was overall survival. Results: The median overall survival was 10.8 months in the FOLFIRINOX group as compared with 7.4 months in the gemcitabine group (hazard ratio for death, 0.48; 95% confidence interval [CI], 0.41 to 0.68; P < 0.001). Median progression-free survival was 5.6 months in the FOLFIRINOX group and 3.1 months in the gemcitabine group (hazard ratio for disease progression, 0.44; 95% CI, 0.29 to 0.49; P < 0.001). The objective response rate was 29.6% in the FOLFIRINOX group versus 8.3% in the gemcitabine group (P < 0.001). More adverse events were noted in the FOLFIRINOX group; 4.8% of patients in this group had febrile neutropenia. At 6 months, 29% of the patients in the FOLFIRINOX group had a definitive degradation of the quality of life versus 59% in the gemcitabine group (hazard ratio, 0.45; 95% CI, 0.29 to 0.68; P < 0.001). Conclusions: As compared with gemcitabine, FOLFIRINOX was associated with a survival benefit at the cost of increased toxicity. Thus, FOLFIRINOX is an option for the treatment of patients with metastatic pancreatic cancer having good performance status. Disclosure: All authors have declared no conflicts of interest.