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with impaired HRQoL . Knowledge of elevated PSA may
impact HRQoL by persistently increasing anxiety . How-
ever, we administered PRO questionnaires before releasing
PSA results to patients, potentially avoiding an impact on
PROs. There was also a higher proportion of patients
evaluable at 61 wk with enzalutamide (84 [46%]) versus
bicalutamide (39 [20%]) due to earlier disease progression
(which mandated study drug discontinuation) with bica-
lutamide, at which time PRO data collection ceased;
sensitivity analysis partly addressed these concerns. At
enrolment, bicalutamide was considered a second-line
treatment option for mCRPC. However, with the introduc-
tion of novel treatments for mCRPC, bicalutamide may no
longer be considered standard second-line therapy in some
countries, particularly due to its inferior performance
versus enzalutamide in this and another head-to-head trial
. Lastly, the globally accepted 50-mg daily dose was
chosen as the comparator for this trial even though
bicalutamide 150 mg/d has demonstrated efficacy in
androgen-sensitive prostate cancer, given the absence of
prospective, evidence-based data for the higher dosage
regimen inmen with CRPC. The 50-mg dose was also chosen
because this is the guideline-recommended dose due to the
lack of clinical studies using 150 mg in the context of
maximum androgen deprivation therapy.
5. Conclusions
In patients with asymptomatic or mildly symptomatic
mCRPC, enzalutamide provides benefit not only on clinical
efficacy outcomes, as previously reported, but also on
HRQoL, compared with bicalutamide. Further investigation
of potential correlations between clinical responses, surro-
gate efficacy markers, and PROs are warranted.
Author contributions: Axel Heidenreich had full access to all the data in
the study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design: Heidenreich, Chowdhury, Holmstrom.
Acquisition of data: Heidenreich, Chowdhury, Klotz, Villers, Baron.
Analysis and interpretation of data: Heidenreich, Chowdhury, Klotz,
Siemens, Villers, Ivanesscu, Holmstrom, Baron, Wang, Lin, Shore.
Drafting of the manuscript: Heidenreich, Chowdhury, Siemens, Villers,
Ivanescu, Holmstrom, Shore.
Critical revision of the manuscript for important intellectual content:
Heidenreich, Chowdhury, Klotz, Siemens, Villers, Ivanescu, Holmstrom,
Baron, Wang, Lin, Shore.
Statistical analysis: Ivanescu, Baron.
Obtaining funding: None.
Administrative, technical, or material support: None.
Supervision: None.
Other: None.
Financial disclosures: Axel Heidenreich certifies that all conflicts of
interest, including specific financial interests and relationships and
affiliations relevant to the subject matter or materials discussed in the
manuscript (eg, employment/affiliation, grants or funding, consultancies,
honoraria, stock ownership or options, expert testimony, royalties, or
patents filed, received, or pending), are the following: Heidenreich
received honoraria and funding for participation in speaker’s bureaus
from Amgen, Astellas, Bayer, Dendreon, Ferring, Ipsen, Janssen-Cilag,
Pfizer, Sanofi-Aventis, and Takeda and research funding from Astellas,
Bayer, and Sanofi. Chowdhury was a consultant, advisor, meeting
participant and lecturer for Astellas, Johnson & Johnson, Sanofi, and
Dendreon during the conduct of the study. Klotz reports honoraria for
advisory board participation from Astellas, Medivation, Janssen, Amgen,
Genomic Health, and AbbVie, outside the submitted work. Siemens
reports involvement in scientific studies and trials with Astellas, BN
ImmunoTherapeutics, and Janssen during the conduct of the study. Villers
reports being a consultant/advisor for Astellas, Janssen, and Takeda and
involvement in scientific studies and trials with Astellas, Ferring, and
Ipsen. Ivanescu is an employee of Quintiles, and Quintiles received
funding from Astellas to conduct the analyses reported here. Holmstrom
and Baron are employees of Astellas. Wang and Lin are employees of
Medivation. Shore was a consultant to Amgen, Astellas, Bayer, Ferring,
Medivation, Janssen, Sanofi, and Tolmar during the conduct of the study.
Funding/support and role of the sponsor: This study was funded by
Astellas Pharma, Inc. and Medivation, Inc., the codevelopers of
enzalutamide. Astellas and Medivation had a role in the design and
conduct of the study; the collection, management, and analysis of the
data; and review of the study. The authors had full access to the data and
participated in reviewing and interpreting the data and paper. Writing
assistance and editorial support was funded by Astellas and Medivation.
Acknowledgments: The authors would like to thank Thomas Lavelle of
Bioscript Science for assistance with writing and revising the draft
manuscript, based on detailed discussion and feedback from all authors,
and Jane Beck of Complete HealthVizion for editorial assistance.
Appendix A. Supplementary data
Supplementary data associated with this article can be
found, in the online version, at
.
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