Enzalutamide was associated with improved overall survival and radiographic progression-free survival compared with placebo in elderly men 75 years or older with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) and was well tolerated, a study published in the journal Annals of Oncology has shown.1
Because prostate cancer disproportionately affects older men and age impacts patient management, it is important to understand the efficacy and safety of advanced prostate cancer therapies in elderly men.
Therefore, researchers performed an analysis of the phase 3 PREVAIL trial to assess the safety and efficacy of enzalutamide, an androgen receptor inhibitor, in patients aged 75 years or older.
In the double-blind, international, PREVAIL trial, 1717 chemotherapy-naïve men with mCRPC were randomly assigned to receive enzalutamide 160 mg orally daily or placebo. Of those, 609 patients were elderly.
RELATED: Dose-intensified SRT Minimally Impacts Quality of Life in Biochemical Recurrent Prostate Cancer
Results showed that overall survival was 32.4 months (95% CI: 27.7-not yet reached) in the enzalutamide group and 25.1 months (95% CI: 22.6-28.0) in the placebo group among elderly patients (HR, 0.61; 95% CI: 0.47-0.79; P = .0001). Radiographic progression-free survival was not yet reached (95% CI: 12.3-not yet reached) vs 3.7 months (95% CI: 3.6-5.3), respectively (HR, 0.17; 95% CI: 0.12-0.24; P < .0001).
In regard to safety, the incidence of adverse events was similar in both treatment arms, but there was an overall higher incidence of falls among elderly patients compared with younger patients and among elderly patients receiving enzalutamide vs those receiving placebo.
- Graff JN, Baciarello G, Armstrong AJ, et al. Efficacy and safety of enzalutamide in patients 75 years or older with chemotherapy-naive metastatic castration-resistant prostate cancer: results from PREVAIL [published online ahead of print November 16, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv542.