A phase II trial of tegafur-uracil plus leucovorin (LV) in the treatment of advanced biliary tract carcinomas.
OBJECTIVE
To evaluate the efficacy and safety profile of oral tegafur-uracil (tegafur combined with uracil in a molar of 1:4 ratio) plus leucovorin (LV) in patients with advanced biliary tract carcinoma (BTC).


METHODS
Sixteen chemotherapy-naïve patients (nine males and seven females with a median age of 58.0 years) with BTC were prospectively enrolled in this study. The dose of tegafur-uracil (UFUR; TTY Biopharm Co. Ltd, Taipei, Taiwan) was 300 mg/m(2)/d (according to the dose of tegafur) and LV was 60 mg/day on day 1-28, followed by a 1-week break. The site of primary tumor included 10 intrahepatic cholangiocarcinomas (CC), one perihilar CC, four gallbladder cancers and one periampullar cancer. Fourteen patients were evaluated for tumor response.


RESULTS
No objective complete or partial responses were observed. Two patients had stable disease and 12 patients had disease progression. The median time to progression was 68 days (8-159 days) and the median survival time was 155 days (69-570 days). Sixteen patients were evaluable for toxicity. Grade III/IV toxicities were found in two patients only; one patient had grade III thrombocytopenia and one patient stopped therapy early due to grade IV diarrhea.


CONCLUSIONS
Oral tegafur-uracil plus LV is well tolerated but ineffective in patients with advanced BTC.
Chen
Jen-Shi
JS
Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital, Taipei, Taiwan. fong0301@ms18.hinet.net
Yang
Tsai-Shen
TS
Lin
Yung-Chang
YC
Jan
Yi-Yin
YY
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D013921:Thrombocytopenia / Q000139:chemically induced; D014498:Uracil / Q000008:administration & dosage
D005641:Tegafur; D014498:Uracil; D002955:Leucovorin