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Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk.

Publication ,  Journal Article
Azad, AA; Armstrong, AJ; Alcaraz, A; Szmulewitz, RZ; Petrylak, DP; Holzbeierlein, J; Villers, A; Alekseev, B; Iguchi, T; Shore, ND; Rosbrook, B ...
Published in: Prostate Cancer Prostatic Dis
February 2022

BACKGROUND: While enzalutamide plus androgen deprivation therapy (ADT) significantly reduces the risk of radiographic progression-free survival (rPFS) and improves overall survival in metastatic hormone-sensitive prostate cancer (mHSPC), the efficacy in clinically relevant subgroups of patients based on prior local and systemic therapy, disease volume, and risk has not been analyzed to date. These post hoc analyses of the phase 3 ARCHES trial (NCT02677896) evaluated the efficacy of enzalutamide plus ADT according to prior local and systemic treatment, disease volume, and risk, assessed at trial baseline. METHODS: In ARCHES, a global, double-blind, placebo-controlled, phase 3 study, 1150 patients with mHSPC were randomized 1:1 to receive enzalutamide (160 mg/day) plus ADT or placebo plus ADT, stratified by prior docetaxel therapy and disease volume. Primary endpoint was rPFS. Secondary endpoints included time to prostate-specific antigen progression, symptomatic skeletal events, and prostate-specific antigen and radiographic responses. Analyses of clinical endpoints were completed by prior local therapy, prior docetaxel exposure, CHAARTED (NCT00309985)-defined disease volume, and LATITUDE (NCT01715285)-defined risk groups. RESULTS: Patients were randomized to enzalutamide plus ADT (n = 574) and placebo plus ADT (n = 576). Enzalutamide plus ADT significantly improved rPFS (hazard ratio: 0.39; p < 0.0001), with similar improvements reported in all subgroups based on prior local and docetaxel treatment, disease volume, and risk. Treatment benefits were observed with enzalutamide plus ADT in multiple secondary clinical endpoints in the overall population and all subgroups. CONCLUSIONS: Enzalutamide plus ADT demonstrated clinical benefit across all patients with mHSPC, irrespective of prior local and systemic treatment, disease volume, and risk.

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Published In

Prostate Cancer Prostatic Dis

DOI

EISSN

1476-5608

Publication Date

February 2022

Volume

25

Issue

2

Start / End Page

274 / 282

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Treatment Outcome
  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Phenylthiohydantoin
  • Nitriles
  • Male
  • Humans
  • Hormones
  • Docetaxel
 

Citation

APA
Chicago
ICMJE
MLA
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Azad, A. A., Armstrong, A. J., Alcaraz, A., Szmulewitz, R. Z., Petrylak, D. P., Holzbeierlein, J., … Stenzl, A. (2022). Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis, 25(2), 274–282. https://doi.org/10.1038/s41391-021-00436-y
Azad, Arun A., Andrew J. Armstrong, Antonio Alcaraz, Russell Z. Szmulewitz, Daniel P. Petrylak, Jeffrey Holzbeierlein, Arnauld Villers, et al. “Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk.Prostate Cancer Prostatic Dis 25, no. 2 (February 2022): 274–82. https://doi.org/10.1038/s41391-021-00436-y.
Azad AA, Armstrong AJ, Alcaraz A, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, et al. Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):274–82.
Azad, Arun A., et al. “Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk.Prostate Cancer Prostatic Dis, vol. 25, no. 2, Feb. 2022, pp. 274–82. Pubmed, doi:10.1038/s41391-021-00436-y.
Azad AA, Armstrong AJ, Alcaraz A, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Rosbrook B, Lee H-J, Haas GP, Stenzl A. Efficacy of enzalutamide in subgroups of men with metastatic hormone-sensitive prostate cancer based on prior therapy, disease volume, and risk. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):274–282.

Published In

Prostate Cancer Prostatic Dis

DOI

EISSN

1476-5608

Publication Date

February 2022

Volume

25

Issue

2

Start / End Page

274 / 282

Location

England

Related Subject Headings

  • Urology & Nephrology
  • Treatment Outcome
  • Prostatic Neoplasms
  • Prostate-Specific Antigen
  • Phenylthiohydantoin
  • Nitriles
  • Male
  • Humans
  • Hormones
  • Docetaxel