Expanded phase II trial of gemcitabine and capecitabine for advanced biliary cancer

AbstractBACKGROUND.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 first‐line treatment with capecitabine at a dose of 650 mg/m2 twice daily for 14 days and gemcitabine at a dose of 1000 mg/m2 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 follow‐up of 9.5 months, the overall response rate was 29% (95% confidence interval [95% CI], 19.4–41%), with a median duration of 9.7 months (range, 3–36 months). Three patients achieved complete responses, with a median duration of 17 months (range, 9–27 months). The median progression‐free survival and overall survivals were 6.2 months (95% CI, 4.4–8.3 months) and 12.7 months (95% CI, 9.5–31 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. © 2007 American Cancer Society.

Expanded phase II trial of gemcitabine and capecitabine for advanced biliary cancer Journal Articles