Beer.Īt the time of the interim analysis at a median follow-up of 22 months, enzalutamide was associated with a 29% reduction in the risk of death, with an estimated median overall survival of 32.4 months in the enzalutamide arm versus 30.2 months in the placebo arm ( p<.0001). “The study was stopped early by the independent data safety monitoring committee for superior efficacy and overall benefit-to-risk ratio, and the DSMC recommended that placebo patients be crossed over to enzalutamide,” said Dr.
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About 12% of the patients enrolled had metastases to the liver and/or lung. Participants had previously received treatment with hormone therapy, typically with a luteinizing hormone-releasing hormone agonist with or without a first-generation anti-androgen and, when indicated, treatment for the primary tumor (ie, surgery or radiation therapy).
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ACT OF WAR DIRECT ACTION EA ACCESS ERROR PLUS
They were randomized to enzalutamide or placebo plus standard hormone therapy. PREVAIL is a double-blind, placebo-controlled study of 1,717 men with asymptomatic or mildly symptomatic mCRPC who were chemotherapy naïve. Beer presented at the Genitourinary Cancers Symposium in San Francisco.Įnzalutamide is already approved by the FDA in patients with mCRPC, but only in the post-docetaxel (Taxotere) setting.
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These data are from the phase III international PREVAIL study, the results of which Dr. San Francisco-The second-generation androgen receptor antagonist enzalutamide (XTANDI) significantly improved survival and delayed the time to chemotherapy in men with previously untreated metastatic castrate-resistant prostate cancer (mCRPC), according to a recent study.Ĭompared with placebo, treatment with enzalutamide was associated with a near 30% reduction in the risk of death and a marked decrease in the risk of radiographic progression, according to first author Tomasz Beer, MD, professor of medicine and deputy director of the Knight Cancer Institute at Oregon Health & Science University, Portland.