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Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study.

Publication ,  Journal Article
Stenzl, A; Dunshee, C; De Giorgi, U; Alekseev, B; Iguchi, T; Szmulewitz, RZ; Flaig, TW; Tombal, B; Morlock, R; Ivanescu, C; Ramaswamy, K ...
Published in: Eur Urol
October 2020

BACKGROUND: In the ARCHES study in metastatic hormone-sensitive prostate cancer (mHSPC), enzalutamide plus androgen deprivation therapy (ADT) improved radiographic progression-free survival (rPFS) versus ADT alone. OBJECTIVE: To evaluate patient-reported outcomes (PROs) to week 73. DESIGN, SETTING, AND PARTICIPANTS: ARCHES (NCT02677896) was a randomised, double-blind, placebo-controlled, phase 3 study in mHSPC patients. INTERVENTION: Enzalutamide (160 mg/day) plus ADT or placebo plus ADT. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: PROs were assessed at baseline, week 13, and every 12 wk until disease progression using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate 25 (QLQ-PR25), Functional Assessment of Cancer Therapy-Prostate (FACT-P), Brief Pain Inventory Short Form, and EuroQoL 5-Dimensions, 5-Levels (EQ-5D-5 L) instruments. Endpoints included time to first (TTFD) and first confirmed (TTFCD) clinically meaningful deterioration (using predefined questionnaire thresholds) in health-related quality of life (HRQoL) and pain. RESULTS AND LIMITATIONS: A total of 1150 patients received ADT plus enzalutamide (n = 574) or placebo (n = 576). Baseline PRO scores indicated high HRQoL and low pain, which was generally maintained in both groups. There were no statistically significant (nominal p > 0.05) between-group differences that occurred in both TTFD and TTFCD together for QLQ-PR25 and FACT-P scores. Enzalutamide significantly delayed TTFD in worst pain (by ∼3 mo; nominal p = 0.032), pain severity (nominal p = 0.021), and EQ-5D-5 L visual analogue scale score (nominal p = 0.0070) versus placebo (not significant for confirmed deterioration for pain outcomes). Enzalutamide delays deterioration in several HRQoL subscales and pain severity in high-volume disease. CONCLUSIONS: Enzalutamide plus ADT enables men with mHSPC to maintain high-functioning HRQoL and low symptom burden. PATIENT SUMMARY: This study examined the effect on health-related quality of life and pain of adding enzalutamide or placebo to androgen deprivation therapy for patients with metastatic hormone-sensitive prostate cancer. Addition of enzalutamide allowed patients to maintain their health-related quality of life.

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Published In

Eur Urol

DOI

EISSN

1873-7560

Publication Date

October 2020

Volume

78

Issue

4

Start / End Page

603 / 614

Location

Switzerland

Related Subject Headings

  • Urology & Nephrology
  • Time Factors
  • Quality of Life
  • Prostatic Neoplasms, Castration-Resistant
  • Phenylthiohydantoin
  • Patient Reported Outcome Measures
  • Nitriles
  • Neoplasm Metastasis
  • Male
  • Humans
 

Citation

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Stenzl, A., Dunshee, C., De Giorgi, U., Alekseev, B., Iguchi, T., Szmulewitz, R. Z., … Armstrong, A. J. (2020). Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study. Eur Urol, 78(4), 603–614. https://doi.org/10.1016/j.eururo.2020.03.019
Stenzl, Arnulf, Curtis Dunshee, Ugo De Giorgi, Boris Alekseev, Taro Iguchi, Russell Z. Szmulewitz, Thomas W. Flaig, et al. “Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study.Eur Urol 78, no. 4 (October 2020): 603–14. https://doi.org/10.1016/j.eururo.2020.03.019.
Stenzl A, Dunshee C, De Giorgi U, Alekseev B, Iguchi T, Szmulewitz RZ, Flaig TW, Tombal B, Morlock R, Ivanescu C, Ramaswamy K, Saad F, Armstrong AJ. Effect of Enzalutamide plus Androgen Deprivation Therapy on Health-related Quality of Life in Patients with Metastatic Hormone-sensitive Prostate Cancer: An Analysis of the ARCHES Randomised, Placebo-controlled, Phase 3 Study. Eur Urol. 2020 Oct;78(4):603–614.

Published In

Eur Urol

DOI

EISSN

1873-7560

Publication Date

October 2020

Volume

78

Issue

4

Start / End Page

603 / 614

Location

Switzerland

Related Subject Headings

  • Urology & Nephrology
  • Time Factors
  • Quality of Life
  • Prostatic Neoplasms, Castration-Resistant
  • Phenylthiohydantoin
  • Patient Reported Outcome Measures
  • Nitriles
  • Neoplasm Metastasis
  • Male
  • Humans