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The efficacy of epirubicin, cisplatin, uracil/tegafur, and leucovorin in patients with advanced biliary tract carcinoma
Article first published online: 11 APR 2005
Copyright © 2005 American Cancer Society
Volume 103, Issue 11, pages 2338–2343, 1 June 2005
How to Cite
Park, K.-H., Choi, I.-K., Kim, S.-J., Oh, S.-C., Seo, J.-H., Choi, C.-W., Kim, B.-S., Shin, S.-W., Kim, Y.-H. and Kim, J.-S. (2005), The efficacy of epirubicin, cisplatin, uracil/tegafur, and leucovorin in patients with advanced biliary tract carcinoma. Cancer, 103: 2338–2343. doi: 10.1002/cncr.21041
- Issue published online: 18 MAY 2005
- Article first published online: 11 APR 2005
- Manuscript Accepted: 25 JAN 2005
- Manuscript Revised: 11 JAN 2005
- Manuscript Received: 10 NOV 2004
- Korea Health 21 R&D Project, Ministry of Health and Welfare, Republic of Korea. Grant Number: 01-PG3-PG6-01GN07-0004
- biliary tract carcinoma;
- uracil plus tegafur (UFT)
Advanced biliary tract carcinoma is among the most prevalent fatal diseases in Korea. However, to our knowledge, to date no effective therapeutic modality has been shown to prolong the survival of patients in the inoperable stages of this disease.
This Phase II study was conducted to determine the efficacy and toxicity of a combined regimen of epirubicin, cisplatin, and uracil/tegafur (UFT) modulated by leucovorin in patients with advanced or recurrent biliary tract carcinoma.
Eleven of 40 patients (27.5%) had gallbladder carcinoma, and the remaining patients had tumors arising from other sites in the biliary tract. All patients were treated with intravenous epirubicin (50 mg/m2 on Day 1), intravenous cisplatin (60 mg/m2 on Day 1), oral UFT (300 mg/m2 per day on Days 1–21), and oral leucovorin (75 mg per day on Days 1–21). Nine patients exhibited a partial response, representing 22.5% of the possible response rate (95% confidence interval [95% CI], 12.8–32.2%) based on an intention-to-treat analysis. The median survival was 34 weeks (95% CI, 20–48 weeks), and the median time to disease progression was 16 weeks (95% CI, 7–25 weeks). Neutropenia and thrombocytopenia comprised dose-limiting toxicity conditions.
The combination of epirubicin, cisplatin, and UFT modulated by leucovorin was active marginally in patients with advanced biliary tract carcinoma and was capable of stabilizing the disease effectively. Because it was a safe and convenient treatment modality, it may be used in outpatient care with only minor toxicity in patients with advanced malignancies of the biliary tract. Cancer 2005. © 2005 American Cancer Society.