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

被引：30

作者：

Smith, Matthew R. ^{[1
]}

Shore, Neal ^{[2
]}

Tammela, Teuvo L. ^{[3
,4
]}

Ulys, Albertas ^{[5
]}

Vjaters, Egils ^{[6
]}

Polyakov, Sergey ^{[7
]}

Jievaltas, Mindaugas ^{[8
]}

Luz, Murilo ^{[9
]}

Alekseev, Boris ^{[10
]}

Kuss, Iris ^{[11
]}

Le Berre, Marie-Aude ^{[12
]}

Mohamed, Ateesha F. ^{[13
]}

Odom, Dawn ^{[14
]}

Bartsch, Jennifer ^{[14
]}

Snapir, Amir ^{[15
]}

Sarapohja, Toni ^{[15
]}

Fizazi, Karim ^{[16
]}

机构：

[1] Massachusetts Gen Hosp, Ctr Canc, Boston, MA 02114 USA

[2] Carolina Urol Res Ctr, Myrtle Beach, SC USA

[3] Tampere Univ Hosp, Tampere, Finland

[4] Tampere Univ, Tampere, Finland

[5] Natl Canc Inst, Vilnius, Lithuania

[6] Stradins Clin Univ Hosp, Riga, Latvia

[7] NN Alexandrov Natl Canc Ctr Belarus, Minsk, BELARUS

[8] Lithuanian Univ Hlth Sci, Med Acad, Kaunas, Lithuania

[9] Hosp Erasto Gaertner, Curitiba, Parana, Brazil

[10] Minist Hlth Russian Federat, Natl Med Res Radiol Ctr, Moscow, Russia

[11] Bayer AG, Clin Stat, Berlin, Germany

[12] Bayer Healthcare SAS, Loos, France

[13] Bayer Healthcare, Whippany, NJ USA

[14] Res Triangle Inst, Durham, NC USA

[15] Orion Corp Orion Pharma, Espoo, Finland

[16] Univ Paris Saclay, Inst Gustave Roussy, Villejuif, France

来源：

EUROPEAN JOURNAL OF CANCER | 2021年 / 154卷

关键词：

Darolutamide; Non-metastatic castration-resistant prostate cancer (nmCRPC); Quality of life; Urinary symptoms; Bowel symptoms; Hormonal treatment-related symptoms; ENZALUTAMIDE; SYMPTOMS; OUTCOMES; PLACEBO; MEN;

D O I：

10.1016/j.ejca.2021.06.010

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (C) 2021 The Authors. Published by Elsevier Ltd.

引用

页码：138 / 146

页数：9

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