Mitomycin C with weekly 24-h infusion of high-dose 5-fluorouracil and leucovorin in patients with biliary tract and periampullar carcinomas

We have reported a 33% partial response rate with acceptable toxicity using weekly 24-h Infusion of high-dose 5-fluorouracil (5-FU) and leucovorin (LV ) in patients with far advanced biliary tract cancers (BTC). In this study, we added mitomycin (MMC) to 5-FU and LV in an attempt to Improve the respo nse rate and survival. From July 1997 to September 1999, 25 chemotherapy-na ive patients with pathology-proven far advanced BTC end periampullar cancer s were enrolled. The regimen consisted of MMC 10 mg/m(2) every 8 weeks comb ined with 5-FU 2600 mg/m(2) and LV 150 mg at a schedule of 24-h infusion we ekly for 6 weeks followed by a 2 week break. There were 10 males and 15 fem ales with a median age of 57 years (range 40-76). The sites of primary tumo r were 15 intrahepatic cholangiocarcinomas (CC), one perihilar CCs, three d istal ETC, three gallbladder cancers (GB) and three periampular cancers. A total of 148 sessions of chemotherapy were given with a mean of 8 (range 2- 18). Nineteen patients were evaluable for response. The response rate was: 26% (five of 19) partial response, 42% (eight of 19) stable disease and 32% (six of 19) progressive disease. All of the patients were evaluable for to xicity. Toxicities more than grade III-IV were thrombocytopenia 16% (four o f 25), leukopenia 12% (three of 25) and vomiting 4% (one of 25). There were four treatment-related deaths. The median time to disease progression was 3 months. The median survival was 6 months. A combination of MMC with weekl y high-dose 5-FU end LV in patients with ETC did not improve the response r ate, but produced more toxicity than weekly high-dose 5-FU and LV alone. [( C) 2001 Lippincott Williams & Wilkins.].