Phase II study of epirubicin, cisplatin, and capecitabine for advanced biliary tract adenocarcinoma

BACKGROUND: Advanced biliary tract carcinomas (BTCs) are associated with a very poor prognosis. New therapeutic strategies therefore are needed to improve efficacy and survival, and the current study was designed with a new, effective drug combination. METHODS: Patients with recurrent or metastatic BTC received a combination of epirubicin at a dose of 50 mg/m(2), cisplatin at a dose of 60 mg/m(2) on Day 1, and capecitabine at a dose of 1000 mg/m(2) twice daily for 2 weeks. Treatment was repeated every 3 weeks. RESULTS: A total of 43 patients (22 with extrahepatic cholangiocarcinoma, 15 with intrahepatic cholangiocarcinoma, and 6 with gallbladder carcinoma) were treated. The median age was 53 years (range, 36-69 yrs) and 5 patients had a Zubrod performance status of 2. Seventeen patients achieved a partial response (40%; 95% confidence interval 95% CI], 21-49%) and 10 had stable disease. With a follow-up duration of 18 months, the median survival time was 8 months (95% CI, 6-10 mos). In total, 187 chemotherapy cycles were delivered, with a median of 5 cycles per patient (range, 1-9 cycles). Toxicity was mainly myelosuppression and mucositis, but no patients died of toxicity. CONCLUSIONS: This combination chemotherapy with epirubicin, cisplatin, and capecitabine offered promising antitumor activity in patients with advanced BTC.