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

Publication ,  Journal Article
Armstrong, AJ; Lin, P; Tombal, B; Saad, F; Higano, CS; Joshua, AM; Parli, T; Rosbrook, B; van Os, S; Beer, TM
Published in: Eur Urol
September 2020

BACKGROUND: In the PREVAIL study, enzalutamide significantly improved clinical outcomes versus placebo in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC). OBJECTIVE: To evaluate long-term benefits and risks of enzalutamide in the final prespecified PREVAIL analysis. DESIGN, SETTING, AND PARTICIPANTS: 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. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Predictors of the primary outcome of overall survival were estimated using the Kaplan-Meier method. Long-term adverse events over time were analyzed. RESULTS AND LIMITATIONS: 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 mo) were associated with greater 5-yr survival. A higher incidence of fatal treatment-emergent adverse events was observed with enzalutamide (6.9% vs 3.8%), with an increase in fatal cardiovascular events (1.6% vs 0.4%). CONCLUSIONS: With >5 yr of follow-up, enzalutamide continued to demonstrate improved survival in patients with mCRPC despite crossover and multiple subsequent effective therapies, balanced against a slightly higher rate of fatal cardiovascular events. PREVAIL is registered on ClinicalTrials.gov as NCT01212991. PATIENT SUMMARY: We report a maintained long-term survival benefit with enzalutamide and risks with >5 yr of enzalutamide treatment and follow-up in men with metastatic prostate cancer, and identify groups of men with widely different outcomes based on clinical factors.

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Published In

Eur Urol

DOI

EISSN

1873-7560

Publication Date

September 2020

Volume

78

Issue

3

Start / End Page

347 / 357

Location

Switzerland

Related Subject Headings

  • Urology & Nephrology
  • Treatment Outcome
  • Time Factors
  • Survival Rate
  • Survival Analysis
  • Prostatic Neoplasms, Castration-Resistant
  • Prognosis
  • Phenylthiohydantoin
  • Nitriles
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
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Armstrong, A. J., Lin, P., Tombal, B., Saad, F., Higano, C. S., Joshua, A. M., … Beer, T. M. (2020). Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol, 78(3), 347–357. https://doi.org/10.1016/j.eururo.2020.04.061
Armstrong, Andrew J., Ping Lin, Bertrand Tombal, Fred Saad, Celestia S. Higano, Anthony M. Joshua, Teresa Parli, Brad Rosbrook, Steve van Os, and Tomasz M. Beer. “Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial.Eur Urol 78, no. 3 (September 2020): 347–57. https://doi.org/10.1016/j.eururo.2020.04.061.
Armstrong, Andrew J., et al. “Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial.Eur Urol, vol. 78, no. 3, Sept. 2020, pp. 347–57. Pubmed, doi:10.1016/j.eururo.2020.04.061.
Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347–357.

Published In

Eur Urol

DOI

EISSN

1873-7560

Publication Date

September 2020

Volume

78

Issue

3

Start / End Page

347 / 357

Location

Switzerland

Related Subject Headings

  • Urology & Nephrology
  • Treatment Outcome
  • Time Factors
  • Survival Rate
  • Survival Analysis
  • Prostatic Neoplasms, Castration-Resistant
  • Prognosis
  • Phenylthiohydantoin
  • Nitriles
  • Male