Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer : An analysis of the phase III ARAMIS trial
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Date
2021-09-01
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Abstract
BACKGROUND: In the ARAMIS trial, darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT significantly improved metastasis-free survival (MFS), overall survival (OS) and time to pain progression in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Herein, we present analyses of patient-reported health-related quality of life (HRQoL) outcomes. PATIENTS AND METHODS: This double-blind, placebo-controlled, phase III trial randomised patients with nmCRPC and prostate-specific antigen doubling time ≤10 months to darolutamide 600 mg (n = 955) twice daily or matched placebo (n = 554) while continuing ADT. The primary end-point was MFS; the secondary end-points included OS and time to pain progression. In this analysis, HRQoL was assessed by the time to deterioration using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) prostate cancer subscale (PCS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Prostate Cancer Module (EORTC QLQ-PR25) subscales. RESULTS: Darolutamide significantly prolonged time to deterioration of FACT-P PCS versus placebo (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.70-0.91; P = 0.0005) at the primary analysis (cut-off date: 3rd September 2018). Time to deterioration of EORTC QLQ-PR25 outcomes showed statistically significant delays with darolutamide versus placebo for urinary (HR 0.64, 95% CI 0.54-0.76; P < 0.0001) and bowel (HR 0.78, 95% CI 0.66-0.92; P = 0.0027) symptoms. Time to worsening of hormonal treatment-related symptoms was similar between the two groups. CONCLUSION: In patients with nmCRPC who are generally asymptomatic, darolutamide maintained HRQoL by significantly delaying time to deterioration of prostate cancer-specific quality of life and disease-related symptoms versus placebo.
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Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
Keywords
Bowel symptoms, Darolutamide, Hormonal treatment–related symptoms, Non-metastatic castration-resistant prostate cancer (nmCRPC), Quality of life, Urinary symptoms, 3.2 Clinical medicine, 3.1 Basic medicine, 1.1. Scientific article indexed in Web of Science and/or Scopus database, Oncology, Cancer Research, SDG 3 - Good Health and Well-being
Citation
Smith, M R, Shore, N, Tammela, T L, Ulys, A, Vjaters, E, Polyakov, S, Jievaltas, M, Luz, M, Alekseev, B, Kuss, I, Le Berre, M A, Mohamed, A F, Odom, D, Bartsch, J, Snapir, A, Sarapohja, T & Fizazi, K 2021, 'Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer : An analysis of the phase III ARAMIS trial', European Journal of Cancer, vol. 154, pp. 138-146. https://doi.org/10.1016/j.ejca.2021.06.010