Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: An analysis of the phase III ARAMIS trial

• DOI: 10.1016/j.ejca.2021.06.010
• Publication Date: 2021-07-14T17:42:53Z
• Authors: Matthew R. Smith; Neal Shore; Teuvo L. Tammela; Albertas Ulys; Egils Vjaters; Sergey Polyakov; Mindaugas Jievaltas; Murilo Luz; Boris Alekseev; Iris Kuss; Marie-Aude Le Berre; Ateesha F. Mohamed; Dawn Odom; Jennifer Bartsch; Amir Snapir; Toni Sarapohja; Karim Fizazi
• Keywords: Clinical endpoint

In the ARAMIS trial, darolutamide plus androgen deprivation therapy (ADT) versus placebo ADT significantly improved metastasis-free survival (MFS), overall (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 life (HRQoL) outcomes.This double-blind, placebo-controlled, phase III trial randomised nmCRPC prostate-specific antigen doubling ≤10 months 600 mg (n = 955) twice daily or matched 554) while continuing ADT. The primary end-point was MFS; secondary end-points included OS progression. this analysis, HRQoL assessed by deterioration using Functional Assessment Cancer Therapy-Prostate (FACT-P) subscale (PCS) European Organisation for Research Treatment Quality Life Questionnaire Prostate Module (EORTC QLQ-PR25) subscales.Darolutamide prolonged FACT-P PCS (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.70-0.91; P 0.0005) at analysis (cut-off date: 3rd September 2018). Time EORTC QLQ-PR25 outcomes showed statistically significant delays urinary (HR 0.64, CI 0.54-0.76; < 0.0001) bowel 0.78, 0.66-0.92; 0.0027) symptoms. worsening hormonal treatment-related symptoms similar between two groups.In who are generally asymptomatic, maintained delaying cancer-specific disease-related placebo.