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Annals of Oncology Advance Access published online on September 9, 2007
Annals of Oncology, doi:10.1093/annonc/mdm439
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© 2007 European Society for Medical Oncology

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

YJ Kim1, S-A Im1,4,*, HG Kim1, SY Oh1, KW Lee1, IS Choi1, DY Oh1,4, SH Lee1,4, JH Kim1, DW Kim1,4, TY Kim1,4, SW Kim3, DS Heo1,4, YB Yoon2 and YJ Bang1,4

1 Division of Hematology and Medical Oncology, Department of Internal Medicine
2 Division of Gastroenterology, Department of Internal Medicine
3 Department of Surgery
4 Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

* Correspondence to: Dr S.-A. Im, Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University College of Medicine, 28 Yongon-dong, Chongno-gu, Seoul, 110–744 Korea. Tel: +82-2-2072-0850; Fax: +82-2-762-9662; E-mail: moisa{at}snu.ac.kr

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.

Biliary tract cancer, Cisplatin, S-1

Received for publication June 10, 2007. Revision received August 6, 2007. Accepted for publication August 7, 2007.


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