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Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma
Article first published online: 17 NOV 2005
Copyright © 2005 American Cancer Society
Volume 104, Issue 12, pages 2753–2758, 15 December 2005
How to Cite
Cho, J. Y., Paik, Y. H., Chang, Y. S., Lee, S. J., Lee, D.-K., Song, S. Y., Chung, J. B., Park, M.-S., Yu, J.-S. and Yoon, D.-S. (2005), Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma. Cancer, 104: 2753–2758. doi: 10.1002/cncr.21591
- Issue published online: 8 DEC 2005
- Article first published online: 17 NOV 2005
- Manuscript Accepted: 28 JUL 2005
- Manuscript Revised: 24 JUL 2005
- Manuscript Received: 31 MAY 2005
- F. Hoffmann-La Roche, Ltd. (South Korea)
- biliary tract carcinoma;
- Phase II trial;
Biliary tract carcinoma is an aggressive cancer, with median survival rarely exceeding 6 months. There is currently no established palliative standard of care. A Phase II trial was conducted to study a combination of oral capecitabine and gemcitabine (CapGem) as first-line therapy in patients with advanced and/or metastatic biliary carcinoma.
Patients with unresectable or metastatic intrahepatic or extrahepatic biliary duct carcinoma and gallbladder carcinoma were enrolled. Eligible patients had histologically or cytologically confirmed, measurable adenocarcinoma and had not received prior therapy with capecitabine or gemcitabine. Treatment consisted of intravenous (i.v.) gemcitabine (1000 mg/m2 on Days 1 and 8) plus oral capecitabine (650 mg/m2 twice daily on Days 1–14) every 3 weeks for up to 6 cycles. Tumor response, survival, and safety were determined.
A total of 44 patients were evaluable. Primary tumor sites were: intrahepatic (n = 14) and extrahepatic biliary duct (n = 16); gallbladder (n = 7); and ampulla (n = 7). Fourteen (32%) patients had a partial response and 15 (34%) patients had stable disease. Median time to disease progression and overall survival were 6.0 (range, 3.8–8.1) and 14 (range, 11.4–16.6) months, respectively. The 1-year survival rate was 58%. No Grade 4 adverse events were seen. Transient Grade 3 neutropenia/thrombocytopenia and manageable (almost invariably Grade 2) nausea, diarrhea, and hand–foot syndrome were the most common adverse events.
CapGem is an active and well tolerated first-line combination chemotherapy regimen for patients with advanced/metastatic biliary tract carcinoma that offers a convenient home-based therapy. Cancer 2005. © 2005 American Cancer Society.