A phase II trial of S-1 and cisplatin in patients with metastatic or relapsed biliary tract cancer

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Abstract
Background: Optimal chemotherapy for advanced biliary tract cancer (BTC) is yet to be defined. We carried out this study to evaluate the efficacy and toxicity of combination chemotherapy with S-1 and cisplatin in metastatic or relapsed BTC. Patients and methods: Patients with pathologically proven BTC were eligible. The chemotherapy regimen consisted of S-1 (40 mg/m2 p.o. b.i.d. from D1–14) and cisplatin (60 mg/m2 on D1), repeated every 3 weeks. Results: Fifty-one BTC patients (metastatic:relapsed = 37:14, Gall-bladder:intrahepatic bile ducts:extrahepatic bile ducts = 16:25:10) were enrolled from January 2005 to December 2006. Median age was 57 years (range, 31–71) and most patients had a good performance status. The overall response rate was 30% [95% confidence interval (CI), 17.3–42.7] and complete response was observed in two patients (4%), partial response in 13 (26%), stable disease in 21 (42%), and progressive disease in 9 (18%). With a median follow-up of 12.4 months, the median time to progression was 4.8 months (95% CI, 3.3–6.3) and median overall survival was 8.7 months (95% CI, 6.0–11.4). Major toxic effects were grade 3/4 neutropenia (8.9% of all cycles) and febrile neutropenia was observed in six cycles (2.7% of all cycles). Conclusion: Combination chemotherapy with S-1 and cisplatin was a moderately effective outpatient-based regimen in BTC patients. Toxic effects were moderate but manageable.