Feasibility and efficacy study of gemcitabine plus cisplatin combination therapy after curative resection for biliary tract cancer.

e15148 Background: Gemcitabine plus Cisplatin (CDDP) combination therapy (GC therapy) has become a standard chemotherapy for advanced biliary tract cancer (BTC). The aim of this study was to assess the feasibility and the efficacy of GC therapy in adjuvant setting. Methods: Eligible patients between January 2008 and January 2013 were enrolled. GC therapy at a dose of 1,000mg/m2, d1, 8 of gemcitabine and 25mg/m2, d1, 8 of CDDP every 3 weeks was performed for 6 months (8 cycles). The primary endpoint was the feasibility and the adverse events. The secondary endpoints were recurrence-free survival (RFS) and overall survival (OS). The study was registered at UMIN Clinical Trials Registry (UMIN000001294) . Results: Totally 30 patients were enrolled, however one withdrew consent prior to chemotherapy. Among the 29 evaluable patients, 20 men and 9 women with a median age of 66 years (range, 49-79 years) were included. All patients had undergone curative resection (R0-1) including 16 with major hepatectomy and 13...