The efficacy of epirubicin, cisplatin, uracil/tegafur, and leucovorin in patients with advanced biliary tract carcinoma

BACKGROUND. 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. METHODS. 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. RESULTS. 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. CONCLUSIONS. 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.