BACKGROUND/AIMS: This phase II study assessed the efficacy and safety of FOLFOX4 as a rescue therapy in patients with gemcitabine-refractory pancreatic cancer. METHODOLOGY: The study included patients with advanced pancreatic cancer who had failed gemcitabine-based chemotherapy. FOLFOX4 was administered biweekly as follows: oxaliplatin, 85 mg/m² as a 2-hour infusion (day 1); leucovorin, 200 mg/m²/day as a 2-hour infusion (days 1 and 2); 5-fluorouracil, bolus 400 mg/m²/day and 600 mg/m²/day as a 22-hour infusion (days 1 and 2).
RESULTS: Forty-four patients received a total of 264 cycles of chemotherapy. There was 1 complete response (2.2%), 4 partial responses (9.1%), and 13 stable diseases (29.5%). The objective response rate was 11.4% and the tumor stabilization rate was 40.9%. The median time to progression was 9.9 weeks (95%CI: 8.2-11.5) and the median overall survival was 31.1 weeks (95%CI: 24.4-37.9). The common adverse events were hematologic toxicities: grade 3 or 4 neutropenia in 19 patients (43.2%), anemia in 9 patients (20.5%), and thrombocytopenia in 6 patients (13.5%). Grade 3 or 4 neuropathy occurred in 4 patients (9.1%).
CONCLUSIONS: In gemcitabine-refractory pancreatic cancer, FOLFOX4 showed encouraging activity and was generally well-tolerated. However, careful attention needs to be paid to hematologic toxicities.