Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer

Cancer research · Prostate cancer

Enzalutamide plus androgen‑deprivation therapy resulted in longer median overall survival than placebo plus androgen‑deprivation therapy among men with nonmetastatic, castration‑resistant prostate cancer and a rapidly rising PSA level.

Background: Preliminary trials suggested that enzalutamide improves metastasis‑free survival in men with nonmetastatic, castration‑resistant prostate cancer (CRPC) and rapidly rising PSA on androgen‑deprivation therapy. Methods: In this double‑blind, phase‑3, 2:1 randomized study, 933 men were assigned to enzalutamide 160 mg daily or placebo while continuing androgen‑deprivation therapy. Primary endpoint was overall survival, evaluated by sequential testing. Results: A total of 288 of 933 (31%) enzalutamide patients and 178 of 468 (38%) placebo patients had died by October 15, 2019. Median overall survival was 67.0 months (95% CI, 64.0 to not reached) in the enzalutamide group versus 56.3 months (95% CI, 54.4 to 63.0) in the placebo group (hazard ratio for death 0.73; 95% CI, 0.61 to 0.89; P = 0.001). Adverse events of grade 3 or higher occurred in 17% of enzalutamide patients versus 20% of placebo patients. Conclusions: Enzalutamide combined with androgen‑deprivation therapy extended overall survival in men with nonmetastatic, castration‑resistant prostate cancer compared with placebo.

Demonstrates a clinically meaningful survival benefit for patients with nonmetastatic, castration‑resistant prostate cancer, supporting enzalutamide as a standard of care in this setting.

Evidence level: Sejtvonalas. Laboratóriumi sejtekben vizsgálták.

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