Randomized phase II study of best available fluoropyrimidine compared with continuation of gemcitabine (Gem) monotherapy in patients with Gem-refractory pancreatic cancer.

Abstract

287 Background: Gem is a standard chemotherapy for unresectable pancreatic cancer (PC) patients (pts); however there is no standard regimen for Gem-refractory PC pts. We often continue to administer Gem for Gem-refractory PC pts because Gem is less toxic. The aim of this study is to elucidate the efficacy of second line treatment in PC. Methods: The pts who were treated with standard dose of Gem and diagnosed disease progression with radiographic findings were randomly allocated to arm A (to treat with best available fluoropyrimidine) or arm B (to continue to treat with standard dose of Gem). Each doctor could choose one of the available fluoropyrimidine (5FU, UFT and S-1) in arm A. Results: We collected 80 patients from Jan, 2004 to Sep, 2008 into this trial. 27 pts (67.5%) were treated with S-1, 8 pts (20%) with UFT and 5 pts (12.5%) with 5FU in arm A. Response Rate were 10% in arm A and 0% in arm B, respectively. Disease Control Rate were 50% and 17.5%, Progression Free Survival Time were 113 days and 50 days (p<0.1050) and Overall Survival Time were 226 days and 161 days (p<0.0384), respectively. Conclusions: Fluoropyrimidine statistically improve survival time in Gem-refractory PC pts, compared to continue Gem. Clinical trial information: UMIN000002154.