Enzalutamide in European and North American men participating in the AFFIRM trial.

ABSTRACT:

Objective

To explore any differences in efficacy and safety outcomes between European (EU) (n = 684) and North American (NA) (n = 395) patients in the AFFIRM trial (NCT00974311).

Patients and methods

Phase III, double-blind, placebo-controlled, multinational AFFIRM trial in men with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel. Participants were randomly assigned in a 2:1 ratio to receive oral enzalutamide 160 mg/day or placebo. The primary end point was overall survival (OS) in a post hoc analysis.

Results

Enzalutamide significantly improved OS compared with placebo in both EU and NA patients. The median OS in EU patients was longer than NA patients in both treatment groups. However, the relative treatment effect, expressed as hazard ratio

SUBMITTER: Merseburger AS 

PROVIDER: S-EPMC4312486 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature