Yonsei Med J.  2005 Aug;46(4):526-531. 10.3349/ymj.2005.46.4.526.

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

• Cho JY
• Nam JS
• Park MS
• Yu JS
• Paik YH
• Lee SJ
• Lee DK
• Yoon DS

• KMID: 1716523
• DOI: http://doi.org/10.3349/ymj.2005.46.4.526

Abstract

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.

Keyword

Capecitabine; gemcitabine; gallbladder cancer

MeSH Terms

Adult
Aged
Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
Deoxycytidine/administration & dosage/adverse effects/*analogs &
Female
Gallbladder Neoplasms/*drug therapy/mortality
Humans
Male
Middle Aged
Survival Rate

Figure

• 

  Fig. I The median TTP was 6.0 months (95% CI, 3.0-8.1 months), and the median overall survival was 16 months (95% CI, 13.8-18.3 months). The 1-year actuarial survival rate was 58%.

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