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Annals of Oncology 14:1115-1120, 2003
© 2003 European Society for Medical Oncology

Original Paper

Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced biliary cancer

T. W. Kim1,+, H. M. Chang1, H. J. Kang1, J. R. Lee1, M. H. Ryu1, J. H. Ahn1, J. H. Kim2, J. S. Lee1 and Y. K. Kang2

1 Section of Hematology–Oncology, Department of Medicine and 2 Department of Radiation Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea

Received 8 January 2003; revised 10 March 2003; accepted 24 March 2003

Background:

A phase II study was conducted to assess the efficacy and tolerability of substituting capecitabine for 5-fluorouracil in combination with cisplatin in patients with advanced biliary cancer.

Patients and methods:

Patients with previously untreated metastatic or unresectable measurable biliary adenocarcinoma received oral capecitabine 1250 mg/m2 twice daily on days 1–14, and intravenous cisplatin 60 mg/m2 on day 1. This cycle was repeated every 21 days.

Results:

Forty-two patients were enrolled in this study. Of these, 38 were assessable for efficacy and 41 were assessable for safety. A median of three cycles of treatment (range one to eight) were administered. One patient achieved a complete response, and eight had partial responses, giving an overall response rate of 21.4% in the intention-to-treat population (95% confidence interval 9.1% to 33.9%). The median response duration was 5.1 months. The median time to progression and median overall survival were 3.7 and 9.1 months, respectively. The most common grade 3/4 adverse events were neutropenia (20% of patients), vomiting (12%), diarrhea (7%) and stomatitis (5%). There were no treatment-related deaths.

Conclusions:

The combination of capecitabine and cisplatin has promising antitumor activity and is well tolerated in patients with advanced biliary cancer.

Key words: biliary tract neoplasms, capecitabine, chemotherapy, cholangiocarcinoma, cisplatin, gall-bladder neoplasms


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