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

Abstract
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.
AuthorsJ S Chen, Y C Lin, Y Y Jan, C T Liau
JournalAnti-cancer drugs (Anticancer Drugs) Vol. 12 Issue 4 Pg. 339-43 (Apr 2001) ISSN: 0959-4973 [Print] England
PMID11335790 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)
Chemical References
  • Mitomycin
  • Leucovorin
  • Fluorouracil
Topics
  • Adenocarcinoma (drug therapy)
  • Adult
  • Aged
  • Ampulla of Vater
  • Antineoplastic Combined Chemotherapy Protocols (administration & dosage, toxicity)
  • Biliary Tract Neoplasms (drug therapy, mortality)
  • Cholangiocarcinoma (drug therapy)
  • Digestive System Neoplasms (drug therapy)
  • Disease Progression
  • Drug Administration Schedule
  • Female
  • Fluorouracil (administration & dosage)
  • Hematologic Diseases (chemically induced)
  • Humans
  • Infusions, Intravenous
  • Leucovorin (administration & dosage)
  • Male
  • Middle Aged
  • Mitomycin (administration & dosage)
  • Survival Rate
  • Treatment Outcome

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