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The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups.

Publication ,  Journal Article
Stenzl, A; Szmulewitz, RZ; Petrylak, D; Holzbeierlein, J; Villers, A; Azad, A; Alcaraz, A; Alekseev, B; Iguchi, T; Shore, ND; Gomez-Veiga, F ...
Published in: Prostate
September 2022

BACKGROUND: Enzalutamide plus androgen deprivation therapy (ADT) improved radiographic progression-free survival versus ADT alone in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in ARCHES (NCT02677896). While health-related quality of life (HRQoL) was generally maintained in the intent-to-treat population, we further analyzed patient-reported outcomes (PROs) in defined subgroups. METHODS: ARCHES was a randomized, double-blind, placebo-controlled, phase 3 study. Patients with mHSPC received enzalutamide (160 mg/day) plus ADT (n = 574) or placebo plus ADT (n = 576). Questionnaires, including the Functional Assessment of Cancer Therapy-Prostate, Brief Pain Inventory-Short Form, and EuroQol 5-Dimension, 5-Level (EQ-5D-5L), were completed at baseline, Week 13, and every 12 weeks until disease progression. PRO endpoints were time to first confirmed clinically meaningful deterioration (TTFCD) in HRQoL or pain. Subgroups included prognostic risk, pain/HRQoL, prior docetaxel, and local therapy (radical prostatectomy [RP] and/or radiotherapy [RT]). RESULTS: There were several between-treatment differences in TTFCD for pain and functioning/HRQoL PROs. Enzalutamide plus ADT delayed TTFCD for worst pain in the prior RT group (not reached vs. 14.06 months; hazard ratio [HR]: 0.56 [95% confidence interval: 0.34-0.94]) and pain interference in low-baseline-HRQoL group (19.32 vs. 11.20 months; HR: 0.64 [0.44-0.94]) versus placebo plus ADT. In prior/no prior RP, prior RT, prior local therapy, no prior docetaxel, mild baseline pain, and low-risk subgroups, TTFCD was delayed for the EQ-5D-5L visual analog scale. CONCLUSION: Enzalutamide plus ADT provides clinical benefits in defined patient subgroups versus ADT alone, while maintaining lack of pain and high HRQoL, with delayed deterioration in several HRQoL measures.

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Published In

Prostate

DOI

EISSN

1097-0045

Publication Date

September 2022

Volume

82

Issue

13

Start / End Page

1237 / 1247

Location

United States

Related Subject Headings

  • Quality of Life
  • Prostatic Neoplasms, Castration-Resistant
  • Prostatic Neoplasms
  • Phenylthiohydantoin
  • Pain
  • Oncology & Carcinogenesis
  • Nitriles
  • Male
  • Humans
  • Hormones
 

Citation

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Stenzl, A., Szmulewitz, R. Z., Petrylak, D., Holzbeierlein, J., Villers, A., Azad, A., … Armstrong, A. J. (2022). The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups. Prostate, 82(13), 1237–1247. https://doi.org/10.1002/pros.24396
Stenzl, Arnulf, Russell Z. Szmulewitz, Daniel Petrylak, Jeffrey Holzbeierlein, Arnauld Villers, Arun Azad, Antonio Alcaraz, et al. “The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups.Prostate 82, no. 13 (September 2022): 1237–47. https://doi.org/10.1002/pros.24396.
Stenzl A, Szmulewitz RZ, Petrylak D, Holzbeierlein J, Villers A, Azad A, et al. The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups. Prostate. 2022 Sep;82(13):1237–47.
Stenzl, Arnulf, et al. “The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups.Prostate, vol. 82, no. 13, Sept. 2022, pp. 1237–47. Pubmed, doi:10.1002/pros.24396.
Stenzl A, Szmulewitz RZ, Petrylak D, Holzbeierlein J, Villers A, Azad A, Alcaraz A, Alekseev B, Iguchi T, Shore ND, Gomez-Veiga F, Ivanescu C, Rosbrook B, Ramaswamy K, Ganguli A, Haas GP, Armstrong AJ. The impact of enzalutamide on quality of life in men with metastatic hormone-sensitive prostate cancer based on prior therapy, risk, and symptom subgroups. Prostate. 2022 Sep;82(13):1237–1247.

Published In

Prostate

DOI

EISSN

1097-0045

Publication Date

September 2022

Volume

82

Issue

13

Start / End Page

1237 / 1247

Location

United States

Related Subject Headings

  • Quality of Life
  • Prostatic Neoplasms, Castration-Resistant
  • Prostatic Neoplasms
  • Phenylthiohydantoin
  • Pain
  • Oncology & Carcinogenesis
  • Nitriles
  • Male
  • Humans
  • Hormones