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Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer
Journal of Clinical Oncology, 10/29/09

Cunningham D et al. – Both gemcitabine (GEM) and fluoropyrimidines are valuable treatment for advanced pancreatic cancer. This open-label study was designed to compare the overall survival (OS) of patients randomly assigned to GEM alone or GEM plus capecitabine (GEM-CAP).On the basis of this trial and the meta-analysis, GEM-CAP should be considered as one of the standard first-line options in locally advanced and metastatic pancreatic cancer.

Methods

Patients with previously untreated histologically or cytologically proven locally advanced or metastatic carcinoma of pancreas with performance status ≤ 2 recruited
Patients randomly assigned to GEM or GEM-CAP
Primary outcome measure survival
Meta-analysis of published studies

Results

Between May 2002 and January 2005, 533 patients randomly assigned to GEM and GEM-CAP arms
GEM-CAP significantly improved objective response rate and progression-free survival
Trend for OS benefit for GEM-CAP was consistent across different prognostic subgroups according to baseline stratification factors (stage and performance status) and remained after adjusting for stratification factors
Meta-analysis of two additional studies involving 935 patients showed a significant survival benefit in favor of GEM-CAP with no intertrial heterogeneity

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