Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial.

European Urology
Andrew J ArmstrongTomasz M Beer

Abstract

In the PREVAIL study, enzalutamide significantly improved clinical outcomes versus placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). To evaluate long-term benefits and risks of enzalutamide in the final prespecified PREVAIL analysis. We conducted a final 5-yr survival analysis of PREVAIL in men with chemotherapy-naïve mCRPC from the enzalutamide (n = 689) and placebo (n = 693) arms. Predictors of the primary outcome of overall survival were estimated using the Kaplan-Meier method. Long-term adverse events over time were analyzed. At the 5-yr data cutoff, 1382 of 1717 (80%) men had died. Enzalutamide reduced the hazard of death by 17% (hazard ratio 0.83; 95% confidence interval [CI] 0.75-0.93; p < 0.001), despite 65%, 54%, and 43% of placebo-treated patients receiving subsequent docetaxel, abiraterone, and enzalutamide, respectively. Median overall survival was 36 mo (95% CI 34-38) in the enzalutamide arm versus 31 mo (95% CI 29-34) in the placebo arm, with a median follow-up of 69 mo. Prognostic modeling showed 5-yr survival rates of 42%, 24%, and 5% for low-, intermediate-, and high-risk groups, respectively. Greater degrees of confirmed prostate-specific antigen declines (≤3 ...Continue Reading

References

Oct 8, 2004·The New England Journal of Medicine·Ian F TannockUNKNOWN TAX 327 Investigators
Apr 20, 2006·Journal of the National Cancer Institute·Daniel P PetrylakE David Crawford
Sep 1, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrew J ArmstrongMario Eisenberger
Nov 3, 2007·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Andrew J ArmstrongMario Eisenberger
Oct 3, 2008·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Johann S de BonoDerek Raghavan
Dec 2, 2009·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Daniel A GalvãoRobert U Newton
Dec 17, 2009·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Andrew J ArmstrongSusan Halabi
Dec 12, 2012·The New England Journal of Medicine·Charles J RyanUNKNOWN COU-AA-302 Investigators
Jul 3, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Charles J RyanHoward I Scher
Jun 3, 2014·The New England Journal of Medicine·Tomasz M BeerUNKNOWN PREVAIL Investigators
Mar 10, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Susan HalabiEric J Small
Feb 9, 2018·The New England Journal of Medicine·Matthew R SmithUNKNOWN SPARTAN Investigators
May 18, 2018·Journal of Cancer Survivorship : Research and Practice·A FinlayC E Short
Jun 28, 2018·The New England Journal of Medicine·Maha HussainCora N Sternberg
Sep 12, 2018·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A J ArmstrongT M Beer
Sep 14, 2018·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Bram De LaereLuc Y Dirix
Mar 14, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrew J ArmstrongDaniel J George

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Citations

Mar 12, 2021·European Journal of Nuclear Medicine and Molecular Imaging·Cem OnalFadil Akyol
Jun 20, 2020·European Urology·Deborah MukherjiCarmel Pezaro
Jun 12, 2021·Expert Opinion on Drug Safety·Fred SaadJean-Baptiste Lattouf

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