Background/aims: Advanced biliary carcinoma have poor prognosis and chemotherapy has been shown to have little impact. The aim of the present study is to clarify the effectiveness of GEM combined with CDDP and 5FU (GFP) therapy for unresectable biliary carcinoma.
Methodology: Fourteen patients with biliary carcinoma (4 patients; gallbladder cancer, 10 patients; biliary tract) who had no prior chemotherapy were enrolled. A triple combination of agents was administered with a 4-week cycle GFP chemotherapy consisting of GEM at 1000 mg/m2 on days 1 and of 5-FU at 250 mg/m2 and CDDP at 3mg/m2 on days 1 to 5.
Results: No patient achieved CR, while five patients achieved PR as assessed by RECIST. The overall response rate from the intent-to-treat analysis was 21.4%. Stable disease was observed in 9 (64.3%) patients. Clinical benefit rate was observed in 14 (85.7%) patients. According to the tumor site, overall response rate was 20.0% in biliary tract carcinoma, on the other hand, 25.0% in gallbladder carcinoma.
Conclusions: The significant antitumor activity of GFP chemotherapy has been seen in patients with advanced biliary carcinoma. However, further evaluation in large numbers of patients is needed to determine the difference in chemosensitivity according to the tumor site.