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Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma

 Jae Yong Cho  ;  Yong Han Paik  ;  Yoon Soo Chang  ;  Se Joon Lee  ;  Dong-Ki Lee  ;  Si Young Song  ;  Jae Bock Chung  ;  Mi-Suk Park  ;  Jeong-Sik Yu  ;  Dong-Sup Yoon 
 CANCER, Vol.104(12) : 2753-2758, 2005 
Journal Title
Issue Date
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Biliary Tract Neoplasms/drug therapy* ; Biliary Tract Neoplasms/mortality ; Biliary Tract Neoplasms/pathology ; Biopsy, Needle ; Bone Neoplasms/secondary ; Capecitabine ; Carcinoma, Ductal/drug therapy* ; Carcinoma, Ductal/secondary* ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Female ; Fluorouracil/analogs & derivatives ; Humans ; Immunohistochemistry ; Liver Neoplasms/secondary ; Lung Neoplasms/secondary ; Lymphatic Metastasis ; Male ; Maximum Tolerated Dose ; Middle Aged ; Neoplasm Staging ; Prognosis ; Risk Assessment ; Survival Analysis ; Treatment Outcome
biliary tract carcinoma ; Phase II trial ; capecitabine ; gemcitabine
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.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Park, Mi-Suk(박미숙) ORCID logo https://orcid.org/0000-0001-5817-2444
Paik, Yong Han(백용한)
Song, Si Young(송시영) ORCID logo https://orcid.org/0000-0002-1417-4314
Yu, Jeong Sik(유정식) ORCID logo https://orcid.org/0000-0002-8171-5838
Yoon, Dong Sup(윤동섭) ORCID logo https://orcid.org/0000-0001-6444-9606
Lee, Dong Ki(이동기) ORCID logo https://orcid.org/0000-0002-0048-9112
Lee, Se Joon(이세준) ORCID logo https://orcid.org/0000-0002-2695-2670
Jang, Yang Soo(장양수) ORCID logo https://orcid.org/0000-0002-2169-3112
Chang, Yoon Soo(장윤수) ORCID logo https://orcid.org/0000-0003-3340-4223
Chung, Jae Bock(정재복)
Cho, Jae Yong(조재용) ORCID logo https://orcid.org/0000-0002-0926-1819
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