Pilot study of combination chemotherapy using irinotecan plus S-1 for metastatic pancreatic cancer

Objective: The aim of this study was to evaluate the efficacy and safety of a combination regimen using irinotecan plus S-1 in patients with metastatic pancreatic cancer. Methods: Based on the results of our previous phase I/II study in patients with gastric and colorectal cancer, we initiated a regimen with irinotecan at 100 mg/m(2) on days 1 and 15 and S-1 at 80 mg/m(2) starting at day 1 for 14 consecutive days, followed by a 14-day rest period. This treatment was repeated every 28 days. Results: From November 2003 to December 2006, a total of 16 patients were enrolled. All patients presented with metastatic disease. Six patients had received prior gemcitabine. The median number of treatment cycles was 4 (range 1-16) and the response rate was 43.7% (95% confidence interval 19.5-68.1). The median time to progression was 4.9 months, and the median survival time was 11.3 months. Grade 3-4 neutropenia developed in 5 of 16 patients and grade 3 diarrhea in 1 patient. Conclusions: The combination of irinotecan and S-1 is feasible and promising for pancreatic cancer. Further evaluation of this combination chemotherapy is required. Copyright (C) 2008 S. Karger AG, Basel.