534 692
Platinum Priority – Prostate Cancer
Editorial by Mark D. Tyson and Alan Bryce on pp. 543–544 of this issue
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
Axel Heidenreich
a , * ,Simon Chowdhury
b ,Laurence Klotz
c ,David Robert Siemens
d ,Arnauld Villers
e ,Cristina Ivanescu
f ,Stefan Holmstrom
g ,Benoit Baron
g ,Fong Wang
h ,Ping Lin
h ,Neal D. Shore
ia
Department of Urology, Cologne University, Cologne, Germany;
b
Department of Urology, Guy’s, King’s, and St Thomas’ Hospital, London, UK;
c
Sunnybrook
Health Sciences Centre, Toronto, ON, Canada;
d
Centre for Applied Urological Research, Queen’s University, Kingston, ON, Canada;
e
Department of Urology,
Lille University Medical Center, Lille University, Lille, France;
f
Quintiles Advisory Services, Hoofddorp, the Netherlands;
g
Astellas Pharma Inc., Leiden, The
Netherlands;
h
Medivation Inc., San Francisco, CA, USA;
i
Carolina Urologic Research Centre, Myrtle Beach, SC, USA
E U R O P E A N U R O L O G Y 7 1 ( 2 0 1 7 ) 5 3 4 – 5 4 2available at
www.scienced irect.comjournal homepage:
www.europeanurology.comArticle info
Article history:
Accepted July 20, 2016
Associate Editor:
Stephen Boorjian
Keywords:
Bicalutamide
Enzalutamide
Metastatic castration-resistant
prostate cancer
Quality of life
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,
* Corresponding author. Klinik und Poliklinik fu¨ r Urologie, Universita¨tsklinikum Ko¨ln, Kerpener
Straße 62, 50937 Ko¨ln, Germany. Tel. +49 221 478 82108; Fax: +49 221 478 82372.
E-mail address:
axel.heidenreich@uk-koeln.de(A. Heidenreich).
http://dx.doi.org/10.1016/j.eururo.2016.07.0270302-2838/
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2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.