Smith MR, Shore N, Tammela TL, Ulys A, Vjaters E, Polyakov S, Jievaltas M, Luz M, Alekseev B, Kuss I, Le Berre MA, Mohamed AF, Odom D, Bartsch J, Snapir A, Sarapohja T, Fizazi K. Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer: an analysis of the phase III ARAMIS trial. Eur J Cancer. 2021 Jul 14;154:138-46.

BACKGROUND: In the ARAMIS trial, darolutamide plus androgen deprivation therapy (ADT) compared with 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). Here, we present analyses of patient-reported health-related quality of life (HRQoL) outcomes in ARAMIS.

PATIENTS AND METHODS: This double-blind, placebo-controlled, phase III trial enrolled patients with nmCRPC and prostate-specific antigen doubling time (PSADT) ≤10 months. Patients were randomised 2:1 to darolutamide 600 mg (two 300 mg tablets) twice daily or matched placebo while continuing ADT. Patients were stratified by baseline PSADT and use of osteoclast-targeted therapy. The primary endpoint was MFS. Secondary endpoints included OS and time to pain progression. In this analysis, HRQoL was assessed by the time to deterioration of 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: 1509 patients were randomised to darolutamide (n = 955) or placebo (n = 554). Darolutamide significantly prolonged time to deterioration of FACT-P PCS versus placebo (HR 0.80, 95% CI 0.70–0.91; P = 0.0005) at the primary analysis (cut-off date: 3 September 2018). Time to deterioration of EORTC QLQ-PR25 outcomes showed statistically significant delays with darolutamide versus placebo for urinary symptoms (HR 0.64, 95% CI 0.54–0.76; P < 0.0001) and bowel symptoms (HR 0.78, 95% CI 0.66–0.92; P = 0.0026). Time to worsening of hormonal treatment-related symptoms was comparable between the two groups.

CONCLUSION: In patients with nmCRPC, who are usually asymptomatic, darolutamide maintained HRQoL by significantly delaying time to deterioration of prostate cancer-specific QoL and disease-related symptoms compared to placebo.

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