A drug safety evaluation of enzalutamide to treat advanced prostate cancer

INTRODUCTION: Prostate cancer (PC) is the most common cancer in North American men. Advanced PC is incurable. The androgen receptor antagonist enzalutamide is used to manage advanced PC, often over a period of months or years; it is therefore important to evaluate the safety profile of enzalutamide. AREAS COVERED: This literature review presents safety data from pivotal trials and real-world data studies of enzalutamide in patients with advanced PC, including metastatic hormone-sensitive prostate cancer (mHSPC), nonmetastatic castration-resistant prostate cancer (nmCRPC), and metastatic castration-resistant prostate cancer (mCRPC). A large body of evidence supports the maintenance or improvement in the health-related quality of life (HRQoL) afforded by enzalutamide treatment in patients with mHSPC, nmCRPC, or chemotherapy-naïve mCRPC, as well as improvement in the HRQoL in patients with later-stage symptomatic mCRPC. Efficacy data from clinical trials are also briefly discussed. EXPERT OPINION: We aim to provide clinicians with a better understanding of how to properly interpret enzalutamide clinical trial safety data. This knowledge may help clinicians guide their patients with PC to achieve optimal clinical benefit from enzalutamide therapy, and to properly manage their patients to mitigate any potential risk.