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Medline ® Abstract for Reference 51

of 'Systemic therapy for advanced cholangiocarcinoma'

Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced biliary cancer.
Kim TW, Chang HM, Kang HJ, Lee JR, Ryu MH, Ahn JH, Kim JH, Lee JS, Kang YK
Ann Oncol. 2003;14(7):1115.
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/m(2) twice daily on days 1-14, and intravenous cisplatin 60 mg/m(2) 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 adverseevents 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.
Section of Hematology-Oncology, Department of Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. twkimmd@amc.seoul.kr