Enzalutamide in Males with Chemotherapy-naïve Metastatic Castration-resistant Prostate Most cancers: Prolonged Evaluation of the Section three PREVAIL Research.
Eur Urol. 2017 Feb;71(2):151-154
Authors: Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller Ok, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B
Enzalutamide considerably improved radiographic progression-free survival (rPFS) and total survival (OS) amongst males with chemotherapy-naïve metastatic castration-resistant prostate most cancers on the prespecified interim evaluation of PREVAIL, a part three, double-blind, randomized research. We evaluated the longer-term efficacy and security of enzalutamide as much as the prespecified variety of deaths within the ultimate evaluation, which included an extra 20 mo of follow-up for investigator-assessed rPFS, 9 mo of follow-up for OS, and four mo of follow-up for security. Enzalutamide decreased the chance of radiographic development or loss of life by 68% (hazard ratio [HR] Zero.32, 95% confidence interval [CI] Zero.28-Zero.37; p<Zero.0001) and the chance of loss of life by 23% (HR Zero.77, 95% CI Zero.67-Zero.88; p=Zero.0002). Median investigator-assessed rPFS was 20.Zero mo (95% CI 18.9-22.1) within the enzalutamide arm and 5.four mo (95% CI four.1-5.6) within the placebo arm. Median OS was 35.three mo (95% CI 32.2-not but reached) within the enzalutamide arm and 31.three mo (95% CI 28.Eight-34.2) within the placebo arm. On the time of the OS evaluation, 167 sufferers within the placebo arm had crossed over to obtain enzalutamide. The commonest opposed occasions within the enzalutamide arm have been fatigue, again ache, constipation, and arthralgia. This ultimate evaluation of PREVAIL gives extra full evaluation of the medical advantage of enzalutamide. PREVAIL is registered on ClinicalTrials.gov as NCT01212991.
PATIENT SUMMARY: Based on knowledge from longer follow-up, enzalutamide continued to offer profit over placebo in sufferers with metastatic castration-resistant prostate most cancers.
PMID: 27477525 [PubMed – indexed for MEDLINE]