Effects of 5-fluorouracil and leucovorin in the treatment of pancreatic-biliary tract adenocarcinomas

Adenocarcinomas of the pancreas and biliary tract are highly malignant neop lasms, which are found in the advanced stage. Chemotherapy commonly plays a palliative role in the treatment of pancreatic and biliary tract cancers. 5-Fluorouracil (5-FU) is the most widely studied single agent; the response rate of 5-FU is only 20%. Recently, some reports presented interesting res ults, in which 5-FU, modulated with levofolinic acid (leucovorin), was acti ve in patients with colorectal cancer. In relation, we performed a phase II study of 5-FU, modulated with leucovorin, in patients affected by advanced pancreatic or biliary tract cancer. Fifty-one patients with nonresectable carcinomas of the pancreas or biliary tract admitted to Korea University Ho spital between May 1995 and December 1998 were included in this study. Chem otherapy consisted of leucovorin 25 mg/m(2)/day by 2-hour intravenous infus ion, followed by 5-FU 375 mg/m(2)/day by bolus intravenous infusion, fr-m d ay 1 to day 5. The treatment was repeated every 3 to 4 weeks. A total of 51 eligible patients with advanced adenocarcinoma of the pancreas or biliary tract were enrolled. Of 23 enrolled patients with pancreatic adenocarcinoma , one patient showed complete remission with a survival duration of 13 mont hs (response duration was 9 months). Three patients had partial responses ( PRs) with survival times of 6, 12, and 15 months, respectively. The overall response rate was 17.4% (95% confidence interval [CI], 7.2%-36.2%). The me dian time of overall survival was 6 months(range: 1-15 months). Of 28 enrol led patients with biliary tract cancer, complete responses were observed in 2 patients (7.1%) with survival time of 14 and 16 months, respectively. Se ven patients had PRs with a median survival of 8 months. The overall respon se rate was 32.1% (95% CI, 20.3%-57.5%). The median time of overall surviva l was 6 months (range: 1-16 months). The most prominent toxicity was mucosi tis. Hematologic toxicity was less severe. 5-Fluorouracil in modulation wit h intravenous leucovorin is well tolerated by patients with stage IV pancre atic adenocarcinoma or biliary tract cancer. Although the response rate for patients with pancreatic adenocarcinoma is not better than that achieved u sing 5-FU monochemotherapy, the 32.1% overall response rate achieved in pat ients with biliary tract cancer suggests that 5-FU modulation with leucovor in is active in biliary tract cancer.