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Combining Gemcitabine and Capecitabine in Patients With Advanced Biliary Cancer: A Phase II Trial

From the Departments of Hematology, Medical Oncology, and Biostatistics, Princess Margaret Hospital/University Health Network; and Department of Medicine, University of Toronto

Address reprint requests to J. Knox, MD, Princess Margaret Hospital, 5-218, 610 University Ave, Toronto, Ontario, Canada, M5G 2M9; e-mail: jennifer.knox{at}uhn.on.ca

PURPOSE: Biliary cancer has a poor prognosis, and chemotherapy has had little impact. The objectives of this trial were to determine the response rate, time to disease progression, survival, and safety profile of the combination of gemcitabine and capecitabine (GemCap) in patients with advanced biliary cancer.

PATIENTS AND METHODS: Eligible patients had pathologically proven, locally advanced or metastatic adenocarcinoma arising from the intra- and extrahepatic bile ducts or gallbladder with no prior chemotherapy. Patients were treated on a 3-week cycle consisting of capecitabine at 650 mg/m² orally twice a day for 14 days and gemcitabine at a fixed dose of 1,000 mg/m² intravenously over 30 minutes on days 1 and 8.

RESULTS: Forty-five patients were enrolled between July 2001 and January 2004. Fifty-three percent of patients had cholangiocarcinoma, 47% had gallbladder cancer, and 89% had metastatic disease. The overall objective response rate was 31%, with an additional 42% of patients with stable disease, for a disease control rate of 73%. The median overall survival time was 14 months (95% CI, 7.3 months to not available), and the median progression-free survival time was 7 months (95% CI, 4.6 to 11.8 months). This chemotherapy combination was generally well tolerated. Transient neutropenia, thrombocytopenia, fatigue, and hand-foot syndrome were commonly observed but were easily managed without discontinuing further treatment.

CONCLUSION: The significant antitumor activity combined with a mild toxicity profile seen in this study argue that GemCap chemotherapy may benefit patients with advanced biliary cancer. This regimen warrants further evaluation in a randomized study with survival and quality of life end points.

Supported in part by Hoffman La Roche and Eli Lilly, Canada.

Presented in part at the 2004 Gastrointestinal Cancers Symposium: Current Status and Future Directions for Prevention and Management, San Francisco, CA, January 22-24, 2004; and at the 12th European Cancer Conference, Copenhagen, Denmark, September 21-25, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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