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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dc.contributor.authorSmith, Matthew R.
dc.contributor.authorShore, Neal
dc.contributor.authorTammela, Teuvo L.
dc.contributor.authorUlys, Albertas
dc.contributor.authorVjaters, Egils
dc.contributor.authorPolyakov, Sergey
dc.contributor.authorJievaltas, Mindaugas
dc.contributor.authorLuz, Murilo
dc.contributor.authorAlekseev, Boris
dc.contributor.authorKuss, Iris
dc.contributor.authorLe Berre, Marie Aude
dc.contributor.authorMohamed, Ateesha F.
dc.contributor.authorOdom, Dawn
dc.contributor.authorBartsch, Jennifer
dc.contributor.authorSnapir, Amir
dc.contributor.authorSarapohja, Toni
dc.contributor.authorFizazi, Karim
dc.date.accessioned2021-10-22T17:35:01Z
dc.date.available2021-10-22T17:35:01Z
dc.date.issued2021-09-01
dc.descriptionCopyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.
dc.description.abstractBACKGROUND: 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.en
dc.description.statusPeer reviewed
dc.format.extent9
dc.format.extent779414
dc.identifier.citationSmith, 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
dc.identifier.doi10.1016/j.ejca.2021.06.010
dc.identifier.issn0959-8049
dc.identifier.urihttps://dspace.rsu.lv/jspui/handle/123456789/6710
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85109827770&partnerID=8YFLogxK
dc.language.isoeng
dc.relation.ispartofEuropean Journal of Cancer
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectBowel symptoms
dc.subjectDarolutamide
dc.subjectHormonal treatment–related symptoms
dc.subjectNon-metastatic castration-resistant prostate cancer (nmCRPC)
dc.subjectQuality of life
dc.subjectUrinary symptoms
dc.subject3.2 Clinical medicine
dc.subject3.1 Basic medicine
dc.subject1.1. Scientific article indexed in Web of Science and/or Scopus database
dc.subjectOncology
dc.subjectCancer Research
dc.subjectSDG 3 - Good Health and Well-being
dc.titleDarolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer : An analysis of the phase III ARAMIS trialen
dc.type/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article

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