Overall survival (OS) results of a phase III randomized trial of standard-of-care therapy with or without enzalutamide for metastatic hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led international cooperative group trial
Journal of Clinical Oncology Jun 13, 2019
Sweeney C, et al. - Among men with mHSPC, the impacts of enzalutamide (ENZA, a potent androgen receptor inhibitor) vs a nonsteroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide) in addition to SOC [testosterone suppression (TS) with or without docetaxel (DOC)] were evaluated in ENZAMET. Overall 1125 patients were randomly assigned 1:1 to receive TS plus either ENZA or NSAA. Overall survival was the primary endpoint. A significant improvement in OS was achieved with the addition of ENZA to SOC in mHSPC. In those planned to receive early DOC, lower benefits were seen. Within 30 days of study treatment, the occurrence of serious adverse events (irrespective of attribution) was reported in 42% ENZA vs 34% NSAA, commensurate with the various durations of study treatment.
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