Abstract
BackgroundIn 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 methodsThis 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. ResultsDarolutamide 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. ConclusionIn 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.
Highlights
Prostate cancer is the second most common malignancy in men and is a leading cause of mortality
Baseline Functional Assessment of Cancer TherapyeProstate (FACT-P) prostate cancer subscale (PCS) and EORTC QLQ-PR25 subscale scores were at the high end of the scale in both treatment groups (Table 1)
In the ARAMIS trial of darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, treatment with darolutamide significantly delayed the time to worsening of prostate cancererelated health-related quality of life (HRQoL), as measured by the FACT-P PCS scores, thereby maintaining patients’ QoL for a longer period than placebo
Summary
Prostate cancer is the second most common malignancy in men and is a leading cause of mortality. Androgen deprivation therapy (ADT) is part of the standard of care for patients whose prostate cancer recurs after primary treatment. Most patients with nmCRPC will progress to metastatic CRPC, which is associated with significantly reduced overall survival (OS). Patients with nmCRPC are generally older (median age 73 years in the SPARTAN and PROSPER trials), are asymptomatic and, compared with those with more advanced disease, tend to have reasonable health-related quality of life (HRQoL) [3e5]. 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). Smith et al / European Journal of Cancer 154 (2021) 138e146
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