Universität zu Köln

Heidenreich, Axel, Chowdhury, Simon, Klotz, Laurence, Siemens, David Robert, Villers, Arnauld, Ivanescu, Cristina, Holmstrom, Stefan, Baron, Benoit, Wang, Fong, Lin, Ping and Shore, Neal D. (2017). Impact of Enzalutamide Compared with Bicalutamide on Quality of Life in Men with Metastatic Castration-resistant Prostate Cancer: Additional Analyses from the TERRAIN Randomised Clinical Trial. Eur. Urol., 71 (4). S. 534 - 543. AMSTERDAM: ELSEVIER SCIENCE BV. ISSN 1873-7560

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Abstract

Background: Improving health-related quality of life (HRQoL) is an important goal in metastatic castration-resistant prostate cancer (mCRPC). Objective: To examine the impact of enzalutamide versus bicalutamide on HRQoL in mCRPC. Design, setting, and participants: TERRAIN is a multinational, phase 2, randomised, double-blind study in asymptomatic/mildly symptomatic men with mCRPC (Clinical-Trials. gov, NCT01288911). Patients were randomised (1:1) via an interactive voice and web response system to enzalutamide 160 mg/d (n = 184) or bicalutamide 50 mg/d (n = 191), with androgen deprivation therapy. Outcome measurements and statistical analysis: HRQoL was assessed using Functional Assessment of Cancer Therapy-Prostate (FACT-P), European Quality of Life 5-Domain Scale (EQ-5D), and Brief Pain Inventory, Short-form questionnaires every 12 wk. Primary and secondary analyses utilised mixed models for repeated measures and pattern mixture models, respectively. Results and limitations: At 61 wk, 84 (46%) enzalutamide and 39 (20%) bicalutamide patients in the study were assessed. At 61 wk, changes from baseline favoured enzalutamide versus bicalutamide on three FACT-P domains in mixed models for repeated measures analyses and seven in pattern mixture models analyses. There were no differences in changes for EQ-5D index/visual analogue scale scores. Risk of first deterioration was lower with enzalutamide for FACT-P total (hazard ratio: 0.64, 95% confidence interval: 0.46-0.89, p = 0.007), FACT-G total (hazard ratio: 0.70, 95% confidence interval: 0.50-0.98, p = 0.04), PCS pain (hazard ratio: 0.74, 95% confidence interval: 0.54-1.00, p = 0.048), and EQ-5D index (hazard ratio: 0.66, 95% confidence interval: 0.47-0.93, p = 0.02) scores versus bicalutamide. Brief Pain Inventory, Short-form scores increased in both groups. There was no difference in time-to-pain progression. Study limitations include the exploratory nature of the HRQoL analyses, lack of multiple comparisons corrections, and unknown effects of anxiety/depression on HRQoL. Conclusions: In patients with asymptomatic/mildly symptomatic mCRPC, enzalutamide provides HRQoL benefit versus bicalutamide. Patient summary: Enzalutamide treatment was associated with better health-related quality of life in several domains versus bicalutamide in asymptomatic/mildly symptomatic metastatic castration-resistant prostate cancer. This likely relates to previously reported lower rates of symptomatic disease progression. (C) 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Heidenreich, Axel UNSPECIFIED UNSPECIFIED UNSPECIFIED Chowdhury, Simon UNSPECIFIED UNSPECIFIED UNSPECIFIED Klotz, Laurence UNSPECIFIED UNSPECIFIED UNSPECIFIED Siemens, David Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Villers, Arnauld UNSPECIFIED UNSPECIFIED UNSPECIFIED Ivanescu, Cristina UNSPECIFIED UNSPECIFIED UNSPECIFIED Holmstrom, Stefan UNSPECIFIED UNSPECIFIED UNSPECIFIED Baron, Benoit UNSPECIFIED UNSPECIFIED UNSPECIFIED Wang, Fong UNSPECIFIED UNSPECIFIED UNSPECIFIED Lin, Ping UNSPECIFIED UNSPECIFIED UNSPECIFIED Shore, Neal D. UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-235923
DOI:	10.1016/j.eururo.2016.07.027
Journal or Publication Title:	Eur. Urol.
Volume:	71
Number:	4
Page Range:	S. 534 - 543
Date:	2017
Publisher:	ELSEVIER SCIENCE BV
Place of Publication:	AMSTERDAM
ISSN:	1873-7560
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language MINIMALLY IMPORTANT DIFFERENCES; FUNCTIONAL ASSESSMENT; DOUBLE-BLIND; CHEMOTHERAPY; THERAPY; PAIN; SURVIVAL; RECOMMENDATIONS; ANXIETY; PHASE-3 Multiple languages Urology & Nephrology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/23592