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Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer by Pattern of Metastatic Spread: ARCHES Post Hoc Analyses.

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Armstrong, AJ; Shore, ND; Szmulewitz, RZ; Petrylak, DP; Holzbeierlein, J; Villers, A; Azad, A; Alcaraz, A; Alekseev, B; Iguchi, T; Rosbrook, B ...
Published in: J Urol
May 2021

PURPOSE: Enzalutamide plus androgen deprivation therapy has previously been shown to improve clinical outcomes in men with metastatic hormone-sensitive prostate cancer (ARCHES; NCT02677896). Here, we assessed if and how the pattern of metastatic spread impacts efficacy of enzalutamide plus androgen deprivation therapy in men enrolled in ARCHES. MATERIALS AND METHODS: Men with metastatic hormone-sensitive prostate cancer were randomized 1:1 to enzalutamide (160 mg/day) plus androgen deprivation therapy or placebo plus androgen deprivation therapy, stratified by disease volume and prior docetaxel treatment. The primary end point was radiographic progression-free survival. Secondary end points included time to prostate specific antigen progression, initiation of new antineoplastic therapy, first symptomatic skeletal event and castration resistance. Post hoc analyses were performed by pattern of metastatic spread based on study entry imaging. RESULTS: Of the overall population with metastases identified at enrollment (1,146), the largest patient subgroups were those with bone metastases only (513) and those with bone plus lymph node metastases (351); there were fewer men with lymph node metastases only (154) and men with visceral±bone or lymph node metastases (128). Enzalutamide plus androgen deprivation therapy reduced the risk of radiographic progression vs placebo plus androgen deprivation therapy in men with bone metastases only (HR 0.33) and bone plus lymph node metastases (HR 0.31). Similar improvements in secondary end points were also observed in these subgroups. CONCLUSIONS: These findings indicate that treatment with enzalutamide plus androgen deprivation therapy provides improvements in men with bone and/or lymph node metastases but may be less effective in men with visceral patterns of spread.

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Published In

J Urol

DOI

EISSN

1527-3792

Publication Date

May 2021

Volume

205

Issue

5

Start / End Page

1361 / 1371

Location

United States

Related Subject Headings

  • Urology & Nephrology
  • Treatment Outcome
  • Prostatic Neoplasms, Castration-Resistant
  • Phenylthiohydantoin
  • Nitriles
  • Neoplasm Metastasis
  • Middle Aged
  • Male
  • Humans
  • Double-Blind Method
 

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Armstrong, A. J., Shore, N. D., Szmulewitz, R. Z., Petrylak, D. P., Holzbeierlein, J., Villers, A., … Stenzl, A. (2021). Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer by Pattern of Metastatic Spread: ARCHES Post Hoc Analyses. In J Urol (Vol. 205, pp. 1361–1371). United States. https://doi.org/10.1097/JU.0000000000001568
Armstrong, Andrew J., Neal D. Shore, Russell Z. Szmulewitz, Daniel P. Petrylak, Jeffrey Holzbeierlein, Arnauld Villers, Arun Azad, et al. “Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer by Pattern of Metastatic Spread: ARCHES Post Hoc Analyses.” In J Urol, 205:1361–71, 2021. https://doi.org/10.1097/JU.0000000000001568.
Armstrong AJ, Shore ND, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, et al. Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer by Pattern of Metastatic Spread: ARCHES Post Hoc Analyses. In: J Urol. 2021. p. 1361–71.
Armstrong, Andrew J., et al. “Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer by Pattern of Metastatic Spread: ARCHES Post Hoc Analyses.J Urol, vol. 205, no. 5, 2021, pp. 1361–71. Pubmed, doi:10.1097/JU.0000000000001568.
Armstrong AJ, Shore ND, Szmulewitz RZ, Petrylak DP, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Gomez-Veiga F, Rosbrook B, Lee H-J, Haas GP, Stenzl A. Efficacy of Enzalutamide plus Androgen Deprivation Therapy in Metastatic Hormone-Sensitive Prostate Cancer by Pattern of Metastatic Spread: ARCHES Post Hoc Analyses. J Urol. 2021. p. 1361–1371.
Journal cover image

Published In

J Urol

DOI

EISSN

1527-3792

Publication Date

May 2021

Volume

205

Issue

5

Start / End Page

1361 / 1371

Location

United States

Related Subject Headings

  • Urology & Nephrology
  • Treatment Outcome
  • Prostatic Neoplasms, Castration-Resistant
  • Phenylthiohydantoin
  • Nitriles
  • Neoplasm Metastasis
  • Middle Aged
  • Male
  • Humans
  • Double-Blind Method