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A Phase II Study of Capecitabine Combined with Gemcitabine in Patients with Advanced Gallbladder Carcinoma

 Jae-Yong Cho  ;  Ji-Sun Nam  ;  Mi-Suk Park  ;  Jeong-Sik Yu  ;  Yong-Han Paik  ;  Se-Joon Lee  ;  Dong-Ki Lee  ;  Dong-Sup Yoon 
 YONSEI MEDICAL JOURNAL, Vol.46(4) : 526-531, 2005 
Journal Title
Issue Date
Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Capecitabine ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives* ; Female ; Fluorouracil/analogs & derivatives ; Gallbladder Neoplasms/drug therapy* ; Gallbladder Neoplasms/mortality ; Humans ; Male ; Middle Aged ; Survival Rate
Capecitabine ; gemcitabine ; gallbladder cancer
Capecitabine and gemcitabine are used in the treatment of a variety of solid tumors including pancreatic and biliary tract carcinomas. The authors evaluated survival, response, and toxicity associated with using a combination of capecitabine and gemcitabine to treat patients with unresectable or metastatic gallbladder adenocarcinoma (GBC). Eligible patients had histologically- or cytologically-confirmed GBC, no prior systemic therapy with capecitabine or gemcitabine, Karnofsky Performance Status 70%, serum total bilirubin up to three times normal, and measurable disease. Treatment consisted of gemcitabine 1000 mg/m2 IV on Days 1 and 8 concurrent with administration of capecitabine 1000 mg/m2 PO BID on Days 1 through 14, on a 3-week cycle. Tumor response was assessed by the response evaluation criteria in solid tumors (RECIST criteria) and survival was calculated from initiation of CapGem therapy. A total of 24 patients were enrolled. Median age at the time of diagnosis was 62 years (range, 41-78 years). Fourteen patients had undergone prior surgery. Results showed that eight patients achieved partial response (33%) with an additional 10 patients achieving stable disease (42%). The overall median time to disease progression was 6.0 months (95% CI, 3.8-8.1 months) and overall survival was 16 months (95% CI, 13.8-18.3 months). The one-year survival rate was 58%. No Grade 4 toxicity was seen. Transient Grade 3 neutropenia/thrombocytopenia and manageable nausea, hand-foot syndrome and anorexia were the most common toxicities. Our study shows that CapGem is an active and well-tolerated chemotherapy regimen in patients with advanced GBC.
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1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 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)
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
Cho, Jae Yong(조재용) ORCID logo https://orcid.org/0000-0002-0926-1819
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