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    PCa Tx delays development of non-metastatic disease in some patients


    The median MFS was 36.6 months in the enzalutamide arm compared with 14.7 months in the placebo arm, corresponding to a 71% relative reduction in the risk of developing M1 CRPC (HR 0.29; p<.0001). This advantage to enzalutamide was apparent across all subgroups analyzed, including patients with longer and shorter PSA doubling times, and those with Eastern Cooperative Oncology Group ECOG performance status of 0 or 1 at baseline.

    The proportion of progression events was >50% less in the enzalutamide arm compared with placebo (23% vs. 49%). Some 187 of the 219 (85%) progression events in the enzalutamide group were radiographic compared with 98% in the placebo arm. Fifteen percent of progression events in the enzalutamide arm were death without documented radiographic progression compared with 2% in the placebo arm.

    The time to PSA progression was significantly longer with enzalutamide at 37.2 months, compared with 3.9 months with placebo, for a 93% relative risk reduction (HR 0.07; p<.0001). The time to first use of new antineoplastic therapy was also substantially longer with enzalutamide versus placebo (39.6 vs. 17.7 months; HR 0.21; p<.0001).

    Also see: ADT+EBRT improves OS in men with post-RP LN metastases

    At first interim analysis, median OS was not reached in either arm, but Dr. Hussain emphasized that the median follow-up time was only 22 months in each arm.

    “The interesting part is that there is a 20% reduction in the relative risk of enzalutamide compared to placebo,” said Dr. Hussain.

    Therapy was well tolerated; adverse events were generally consistent with those reported in prior clinical trials of enzalutamide in men with CRPC. Hypertension of any grade occurred in 12% of the enzalutamide group and 5% of the placebo group. The rate of grade 3 or higher hypertension with enzalutamide was 5%.

    Several of Dr. Hussain’s co-authors have served as consultant/advisers to, received honoraria from, and/or have received institutional funding from Astellas Pharma, Pfizer, and/or other pharmaceutical companies. One co-author is an employee of Astellas Pharma and two other co-authors are employees of Pfizer. For a full list of disclosures, click here.

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