Japanese Journal of Clinical Oncology 33:353-356 (2003)
© 2003 Foundation for Promotion of Cancer Research
A Phase II Trial of Tegafur-Uracil Plus Leucovorin (LV) in the Treatment of Advanced Biliary Tract Carcinomas
1 Division of Hematology-Oncology, Department of Internal Medicine and 2 Department of Surgery, Chang Gung Memorial Hospital, Taipei, Taiwan
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/m2/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.
+ For reprints and all correspondence: Jen-Shi Chen, Division of Hematology-Oncology, Departments of Internal Medicine, Chang Gung Memorial Hospital, 199 Tung Hwa North Road, Taipei 105, Taiwan. E-mail: fong0301{at}ms18.hinet.net
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