A controlled trial found that the FOLFIRINOX chemotherapy regimen (oxaliplatin, irinotecan, fluorouracil, and folinate) prolonged survival compared to gemcitabine in patients with metastatic pancreatic cancer; however it was associated with increased toxicity.

The authors note that pancreatic cancer is relatively common and has an extremely poor prognosis (5-year survival 6%). Gemcitabine is the standard treatment, with combinations that include it showing no particular advantage. Based on evidence of effect for other irinotecan and oxaliplatin when combined with fluorouracil, the authors of this study compared the FOLFIRINOX combination with gemcitabine. Study participants were adults with confirmed, previously untreated, pancreatic adenocarcinoma. They were randomised to treatment with FOLFIRINOX or gemcitabine, open label, given for up to six months if there was a response. Primary outcome was progression-free survival.

Patients were randomised to the trial between December 2005 and October 2009, and 342 patients were enrolled during this period. On an intention to treat analysis, FOLFIRINOX was associated with significantly longer overall survival than gemcitabine, 11.0 months vs. 6.8 months (hazard ratio for death, 0.57; 95% CI, 0.45 to 0.73; P<0.001). Progression-free survival was also better (6.4 months vs. 3.3 months; hazard ratio for disease progression, 0.47; 95% CI, 0.37 to 0.59; P<0.001).

Serious adverse events were more frequent in the FOLFIRINOX group, and 5.4% of patients in this group had febrile neutropenia.

The authors conclude that in these patients, FOLFIRINOX had a significant survival advantage over gemcitabine, at the cost of greater toxicity. They suggest that based on their results, it is an option for the treatment of patients with metastatic pancreatic cancer and good performance status.