Phase II study with gemcitabine in gallbladder and biliary tract carcinomas

Background: There is no standard treatment of advanced biliary tract carcinoma. The most commonly used cytotoxic drug 5-fluorouracil (5-FU) has a response rate of only about 10%. In advanced pancreatic carcinoma gemcitabine is superior to 5-FU in terms of tumor-induced symptoms and response rate. In view of the histogenetic affinity between the pancreas and the biliary tract, we decided to test the efficacy of gemcitabine in biliary tract carcinomas. Material and Methods: We treated 13 patients with biliary tract carcinoma with a regimen published by Burris et al. (gemcitabine 1,000 mg/m(2) weekly for 7 weeks, then a pause of 1 week, then cycles of 3-week treatments separated by an interval of 1 week until progression occurs). Inclusion criteria were measurable tumor (CT scan), WHO performance status less than or equal to 2, histologic confirmation, and no previous treatment with gemcitabine. Results: All patients received at least 7 doses of gemcitabine. The results from all patients were evaluable. Two patients experienced WHO grade III toxicity. We observed 1 partial remission lasting more than 5 months after the start of treatment (remission rate 7.7%). Median time until demonstration of tumor progression was 7 months. One patient has shown no change to date. Conclusions: We feel that gemcitabine given in accordance with the regimen tested here is not effective enough to constitute a worthwhile option for the treatment of metastatic gallbladder and biliary tract carcinomas. The long time with stable disease in part of our patients is more probably due to the known slow growth of Klatskin's tumors than to chemotherapy.