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Capecitabine combined with gemcitabine (CapGem) as first‐line treatment in patients with advanced/metastatic biliary tract carcinoma
Author(s) -
Cho Jae Yong,
Paik Yong Han,
Chang Yoon Soo,
Lee Se Joon,
Lee DongKi,
Song Si Young,
Chung Jae Bock,
Park MiSuk,
Yu JeongSik,
Yoon DongSup
Publication year - 2005
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.21591
Subject(s) - medicine , gemcitabine , capecitabine , gastroenterology , regimen , gallbladder , biliary tract , ampulla of vater , carcinoma , gallbladder cancer , adverse effect , neutropenia , oncology , chemotherapy , cancer , colorectal cancer
BACKGROUND 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. METHODS 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/m 2 on Days 1 and 8) plus oral capecitabine (650 mg/m 2 twice daily on Days 1–14) every 3 weeks for up to 6 cycles. Tumor response, survival, and safety were determined. RESULTS 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. CONCLUSIONS 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.