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Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer.

Publication ,  Journal Article
Armstrong, AJ; Azad, AA; Iguchi, T; Szmulewitz, RZ; Petrylak, DP; Holzbeierlein, J; Villers, A; Alcaraz, A; Alekseev, B; Shore, ND; Rosbrook, B ...
Published in: J Clin Oncol
May 20, 2022

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.In primary analysis, enzalutamide plus androgen deprivation therapy (ADT) improved radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC); however, overall survival data were immature. In the phase III, double-blind, global ARCHES trial (ClinicalTrials.gov identifier: NCT02677896), 1,150 patients with mHSPC were randomly assigned 1:1 to enzalutamide (160 mg once daily) plus ADT or placebo plus ADT, stratified by disease volume and prior docetaxel use. Here, we report the final prespecified analysis of overall survival (key secondary end point) and an update on rPFS, other secondary end points, and safety. After unblinding, 180 (31.3%) progression-free patients randomly assigned to placebo plus ADT crossed over to open-label enzalutamide plus ADT. As of May 28, 2021 (median follow-up, 44.6 months), 154 of 574 patients randomly assigned to enzalutamide plus ADT and 202 of 576 patients randomly assigned to placebo plus ADT had died. Enzalutamide plus ADT reduced risk of death by 34% versus placebo plus ADT (median not reached in either group; hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P < .001). Enzalutamide plus ADT continued to improve rPFS and other secondary end points. Adverse events were generally consistent with previous reports of long-term enzalutamide use. In conclusion, enzalutamide plus ADT significantly prolongs survival versus placebo plus ADT in patients with mHSPC.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 20, 2022

Volume

40

Issue

15

Start / End Page

1616 / 1622

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prostatic Neoplasms, Castration-Resistant
  • Prostatic Neoplasms
  • Phenylthiohydantoin
  • Oncology & Carcinogenesis
  • Nitriles
  • Male
  • Humans
  • Hormones
  • Disease-Free Survival
 

Citation

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Armstrong, A. J., Azad, A. A., Iguchi, T., Szmulewitz, R. Z., Petrylak, D. P., Holzbeierlein, J., … Stenzl, A. (2022). Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol, 40(15), 1616–1622. https://doi.org/10.1200/JCO.22.00193
Armstrong, Andrew J., Arun A. Azad, Taro Iguchi, Russell Z. Szmulewitz, Daniel P. Petrylak, Jeffrey Holzbeierlein, Arnauld Villers, et al. “Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer.J Clin Oncol 40, no. 15 (May 20, 2022): 1616–22. https://doi.org/10.1200/JCO.22.00193.
Armstrong AJ, Azad AA, Iguchi T, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, et al. Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2022 May 20;40(15):1616–22.
Armstrong, Andrew J., et al. “Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer.J Clin Oncol, vol. 40, no. 15, May 2022, pp. 1616–22. Pubmed, doi:10.1200/JCO.22.00193.
Armstrong AJ, Azad AA, Iguchi T, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Alcaraz A, Alekseev B, Shore ND, Gomez-Veiga F, Rosbrook B, Zohren F, Yamada S, Haas GP, Stenzl A. Improved Survival With Enzalutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2022 May 20;40(15):1616–1622.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 20, 2022

Volume

40

Issue

15

Start / End Page

1616 / 1622

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Prostatic Neoplasms, Castration-Resistant
  • Prostatic Neoplasms
  • Phenylthiohydantoin
  • Oncology & Carcinogenesis
  • Nitriles
  • Male
  • Humans
  • Hormones
  • Disease-Free Survival