Conroy T, et al. - Researchers investigated the relative efficacy and safety of a modified FOLFIRINOX regimen (combination chemotherapy with fluorouracil, leucovorin, irinotecan, and oxaliplatin) compared with gemcitabine as adjuvant therapy in patients with resected pancreatic cancer. A modified FOLFIRINOX regimen led to significantly longer survival than gemcitabine among these patients, at the expense of a higher incidence of toxic effects.

Methods

• Four hundred and ninety three patients with resected pancreatic ductal adenocarcinoma were randomly assigned 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.
• Disease-free survival was assessed as the primary end point.
• Overall survival and safety were included as secondary end points.

Results

• At a median follow-up of 33.6 months, the modified-FOLFIRINOX group and the gemcitabine group displayed the median disease-free survival of 21.6 months and 12.8 months, respectively (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 two groups had the disease-free survival rate of 39.7% and 21.4%, respectively, at 3 years, and the median overall survival of 54.4 months and 35.0 months, respectively (stratified hazard ratio for death, 0.64; 95% CI, 0.48 to 0.86; P=0.003).
• At 3 years, the modified-FOLFIRINOX group had the overall survival rate of 63.4% and the gemcitabine group had 48.6%.
• In this study, 75.9% of the patients in the modified-FOLFIRINOX group and 52.9% of those in the gemcitabine group experienced adverse events of grade 3 or 4.
• Death of one patient in the gemcitabine group was reported from toxic effects (interstitial pneumonitis).