Abstract
BACKGROUND.
A phase 2 trial of gemcitabine and capecitabine (GemCap) in patients with advanced biliary cancer led to an objective response in approximately 30% of patients and a median survival of 14 months. In the current study, the authors report further efficacy data of a larger cohort of such patients treated with the GemCap regimen.
METHODS.
Patients aged >18 years and who had a diagnosis of locally advanced biliary cancer received firstβline treatment with capecitabine at a dose of 650 mg/m^2^ twice daily for 14 days and gemcitabine at a dose of 1000 mg/m^2^ on Day 1 and Day 8, every 3 weeks until disease progression. Tumor response was assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
RESULTS.
Between July 2001 and January 2005, 75 patients were enrolled in the study. At a median followβup of 9.5 months, the overall response rate was 29% (95% confidence interval [95% CI], 19.4β41%), with a median duration of 9.7 months (range, 3β36 months). Three patients achieved complete responses, with a median duration of 17 months (range, 9β27 months). The median progressionβfree survival and overall survivals were 6.2 months (95% CI, 4.4β8.3 months) and 12.7 months (95% CI, 9.5β31 months), respectively.
CONCLUSIONS.
The GemCap regimen is active in patients with biliary cancer. Randomized trials are warranted to define the impact of such a regimen on patient survival and quality of life. Cancer 2007. Β© 2007 American Cancer Society.