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 response rate and survival. From July 1997 to September 1999, 25
chemotherapy-naive patients with pathology-proven far advanced BTC and periampullar
cancers were enrolled. The regimen consisted of MMC 10 mg/m(2) every 8 weeks combined with
5-FU 2600 mg/m(2) and LV 150 mg at a schedule of 24-h infusion weekly for 6 weeks followed by a 2 week break. There were 10 males and 15 females with a median age of 57 years (range 40-76). The sites of primary
tumor were 15
intrahepatic cholangiocarcinomas (CC), one perihilar CCs, three distal BTC, three
gallbladder cancers (GB) and three periampullar
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 toxicity. Toxicities more than grade III-IV were
thrombocytopenia 16% (four of 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 weekly high-dose
5-FU and LV in patients with BTC did not improve the response rate, but produced more toxicity than weekly high-dose
5-FU and LV alone.