Please use this identifier to cite or link to this item:
10.1016/j.ejca.2021.06.010
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DC Field | Value | Language |
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dc.contributor.author | Smith, Matthew R. | - |
dc.contributor.author | Shore, Neal | - |
dc.contributor.author | Tammela, Teuvo L. | - |
dc.contributor.author | Ulys, Albertas | - |
dc.contributor.author | Vjaters, Egils | - |
dc.contributor.author | Polyakov, Sergey | - |
dc.contributor.author | Jievaltas, Mindaugas | - |
dc.contributor.author | Luz, Murilo | - |
dc.contributor.author | Alekseev, Boris | - |
dc.contributor.author | Kuss, Iris | - |
dc.contributor.author | Le Berre, Marie Aude | - |
dc.contributor.author | Mohamed, Ateesha F. | - |
dc.contributor.author | Odom, Dawn | - |
dc.contributor.author | Bartsch, Jennifer | - |
dc.contributor.author | Snapir, Amir | - |
dc.contributor.author | Sarapohja, Toni | - |
dc.contributor.author | Fizazi, Karim | - |
dc.date.accessioned | 2021-10-22T17:35:01Z | - |
dc.date.available | 2021-10-22T17:35:01Z | - |
dc.date.issued | 2021-09-01 | - |
dc.identifier.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 | - |
dc.identifier.issn | 0959-8049 | - |
dc.identifier.uri | https://dspace.rsu.lv/jspui/handle/123456789/6710 | - |
dc.description | Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved. | - |
dc.description.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. | en |
dc.format.extent | 9 | - |
dc.format.extent | 779414 | - |
dc.language.iso | eng | - |
dc.relation.ispartof | European Journal of Cancer | - |
dc.rights | info:eu-repo/semantics/openAccess | - |
dc.subject | Bowel symptoms | - |
dc.subject | Darolutamide | - |
dc.subject | Hormonal treatment–related symptoms | - |
dc.subject | Non-metastatic castration-resistant prostate cancer (nmCRPC) | - |
dc.subject | Quality of life | - |
dc.subject | Urinary symptoms | - |
dc.subject | 3.2 Clinical medicine | - |
dc.subject | 3.1 Basic medicine | - |
dc.subject | 1.1. Scientific article indexed in Web of Science and/or Scopus database | - |
dc.subject | Oncology | - |
dc.subject | Cancer Research | - |
dc.subject | SDG 3 - Good Health and Well-being | - |
dc.title | Darolutamide and health-related quality of life in patients with non-metastatic castration-resistant prostate cancer : An analysis of the phase III ARAMIS trial | en |
dc.type | /dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article | - |
dc.identifier.doi | 10.1016/j.ejca.2021.06.010 | - |
dc.identifier.url | http://www.scopus.com/inward/record.url?scp=85109827770&partnerID=8YFLogxK | - |
dc.description.status | Peer reviewed | - |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
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Darolutamide_and_health_related_quality_of_life_in_patients.pdf | 761.15 kB | Adobe PDF | View/Open |
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