617PD - A phase III trial comparing FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer

Date 28 September 2014
Event ESMO 2014
Session Gastrointestinal tumours, non-colorectal
Topics Anticancer Agents
Pancreatic Cancer
Biological Therapy
Presenter Mukesh Singhal
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors M.K. Singhal1, A. Kapoor2, P.K. Bagri2, S. Narayan2, D. Singh2, R.K. Nirban3, G. Singh2, S. Maharia3, P. Kumari2, S.L. Jakhar2, S. Beniwal2, N. Sharma2, K. Harsh2, H.S. Kumar2, A. Sharma2, M. Bardia2
  • 1Radiation Oncology, Acharya Tulsi Cancer Treatment & Research Institute, 334003 - bikaner/IN
  • 2Radiation Oncology, Acharya Tulsi Cancer Treatment & Research Institute, 334001 - Bikaner/IN
  • 3Radiation Oncology, Acharya Tulsi Cancer Treatment & Research Institute, 334003 - Bikaner/IN



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.


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.


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).


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.


All authors have declared no conflicts of interest.