O3-004 - Efficacy of Gemcitabine as Second-Line Therapy after Failure of S-1 Therapy for Metastatic Pancreatic Carcinoma

Abstract

ABSTRACT Background S-1 is regarded one of the standard first-line regimens for advanced pancreatic cancer (APC) in Japan, because the GEST study, a randomized phase III clinical trial, revealed the non-inferiority of S-1 alone to GEM. However, no matter whether first-line therapy is S-1 or gemcitabine, no standard second-line chemotherapy has been established yet for cases of APC. In our study, we have evaluated the efficacy and outcomes of second-line GEM therapy after S-1 therapy failure for metastatic pancreatic carcinoma. Method We retrospectively examined the data for 27 patients with metastatic pancreatic carcinoma refractory to first-line S-1 therapy. All the patients had undergone second-line GEM therapy during October 2000–February 2009 at the National Cancer Center Hospital, Tokyo, Japan. Tumor responses were analyzed using the Response Evaluation Criteria in Solid Tumors (RECIST). The Kaplan–Meier method was used to evaluate tumor progression and survival. Result The Eastern Cooperative Oncology Group Performance Status was 0 or 1. The male:female ratio was 16:11 and median age was 62 years (range, 42–72 years). Four patients (14%) exhibited a partial response to second-line GEM therapy, 11 (40%) showed stable disease, and 12 (44%) showed progressive disease. Grade 3 adverse events for second-line GEM therapy were neutropenia in four patients and upper gastrointestinal hemorrhage in two. Grade 4 adverse events were not observed. The median progression-free survival was 70 days (95% confidence interval, 44–95 days) and the median OS after second-line GEM therapy was 229 days (95% confidence interval, 117–340 days). Conclusion Although this study had a small sample population and the design was retrospective, the results indicated that second-line GEM therapy exerted favorite antitumor activity with tolerable toxicity.