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/m2, cisplatin at a dose of 60 mg/m2 on Day 1, and capecitabine at a dose of 1000 mg/m2 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. Cancer 2006. © 2005 American Cancer Society.