Efficacy and safety of axitinib in combination with gemcitabine in advanced pancreatic cancer: subgroup analyses by region, including Japan, from the global randomized Phase III trial.

ABSTRACT:

Objective

Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1-3. This analysis compared efficacy and safety of axitinib plus gemcitabine in patients with advanced pancreatic cancer from Japan, North America and the European Union, enrolled in a randomized Phase III study.

Methods

Patients (n = 632), stratified by disease extent, were randomly assigned (1:1) to receive axitinib/gemcitabine or placebo/gemcitabine. Axitinib was administered at a starting dose of 5 mg orally twice daily and gemcitabine at 1000 mg/m(2) once weekly for 3 weeks in 4 week cycles. Primary endpoint was overall survival.

Results

Among Japanese patients, median overall survival was not estimable (95% confidence interval, 7.4 months-not estimable) with ax

SUBMITTER: Ioka T 

PROVIDER: S-EPMC4412139 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature