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    AR antagonist increases survival vs. older agent

    In men with metastatic castration-resistant prostate cancer, progression-free survival (PFS) is increased in men receiving enzalutamide (Xtandi) compared with those receiving the first-generation androgen receptor blocker bicalutamide (Casodex), study findings showed.

    The phase II study, known as TERRAIN, achieved its primary endpoint, showing a statistically significant increase in PFS for enzalutamide versus bicalutamide (hazard ratio: 0.44; 95% confidence interval: 0.34-0.57; p<.0001). Median PFS was 15.7 months in the enzalutamide group compared to 5.8 months in the bicalutamide group.

    The median time on treatment in TERRAIN was 11.7 months in the enzalutamide group versus 5.8 months in the bicalutamide group. Serious adverse events were reported in 31.1% of enzalutamide-treated patients and 23.3% of bicalutamide-treated patients. Grade 3 or higher cardiac adverse events were reported in 5.5% of enzalutamide-treated patients versus 2.1% of bicalutamide-treated patients.

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    Two seizures were reported in the enzalutamide group and one in the bicalutamide group. The most common side effects occurring during treatment and more common in the enzalutamide-treated versus bicalutamide-treated patients included fatigue, hot flush, hypertension, diarrhea, weight decreased, and pain in extremity.

    Additional data from the trial, including the secondary endpoints and further safety data, will be submitted for presentation at an upcoming medical meeting.

    Next: Robust data set

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