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dc.contributor.authorLoriot, Y
dc.contributor.authorFizazi, K
dc.contributor.authorde Bono, JS
dc.contributor.authorForer, D
dc.contributor.authorHirmand, M
dc.contributor.authorScher, HI
dc.date.accessioned2018-02-14T10:50:17Z
dc.date.issued2017-01
dc.identifier.citationCancer, 2017, 123 (2), pp. 253 - 262
dc.identifier.issn0008-543X
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1070
dc.identifier.eissn1097-0142
dc.identifier.doi10.1002/cncr.30336
dc.description.abstractBackground Patients with metastatic castration-resistant prostate cancer (mCRPC) and visceral metastases have a worse prognosis than those with nonvisceral metastases. Treatment with the androgen receptor inhibitor enzalutamide in the phase 3 AFFIRM trial led to significant improvements in outcomes for patients with mCRPC. For the current report, the authors analyzed the efficacy of enzalutamide among patients from the AFFIRM trial who had visceral disease.Methods Patients who had liver and/or lung metastases at baseline were selected for prespecified overall survival (OS) and exploratory post hoc analyses, including prostate-specific antigen (PSA) response and the time to PSA and radiographic progression.Results In patients who had liver metastases (n = 92), enzalutamide was associated with a lower risk of radiographic progression (hazard ratio [HR], 0.645; 95% confidence interval [CI], 0.413-1.008), improved 12-month OS (37.7% vs 20.6%) and radiographic progression-free survival (rPFS) (11.6% vs 3.0%) rates, and higher PSA response rates (35.1% vs 4.8%) compared with placebo. Enzalutamide-treated patients who had lung metastases (n = 104) had improved median OS (HR, 0.848; 95% CI, 0.510-1.410), a substantially reduced risk of radiographic progression (HR, 0.386; 95% CI, 0.259-0.577), improved 12-month OS (65.1% vs 55.3%) and rPFS (30.9% vs 8.2%) rates, increased time to PSA progression (HR, 0.358; 95% CI, 0.204-0.627), and a better PSA response rate (52.1% vs 4.9%) compared with those who received placebo. No increase in treatment-related adverse events was observed for the visceral metastases cohort compared with the nonvisceral metastases cohort.Conclusions Across multiple endpoints, patients who have visceral metastases have better outcomes with enzalutamide than with placebo. Cancer 2017;123:253-262. © 2016 American Cancer Society.
dc.formatPrint-Electronic
dc.format.extent253 - 262
dc.languageeng
dc.language.isoeng
dc.subjectHumans
dc.subjectLiver Diseases
dc.subjectLung Diseases
dc.subjectDisease Progression
dc.subjectPhenylthiohydantoin
dc.subjectProstate-Specific Antigen
dc.subjectAntineoplastic Agents
dc.subjectDisease-Free Survival
dc.subjectProportional Hazards Models
dc.subjectDouble-Blind Method
dc.subjectAged
dc.subjectMale
dc.subjectProstatic Neoplasms, Castration-Resistant
dc.titleEnzalutamide in castration-resistant prostate cancer patients with visceral disease in the liver and/or lung: Outcomes from the randomized controlled phase 3 AFFIRM trial.
dc.typeJournal Article
dcterms.dateAccepted2016-08-22
rioxxterms.versionofrecord10.1002/cncr.30336
rioxxterms.licenseref.startdate2017-01
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfCancer
pubs.issue2
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Prostate Cancer Targeted Therapy Group
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Prostate Cancer Targeted Therapy Group
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublished
pubs.volume123en_US
pubs.embargo.termsNot known
icr.researchteamProstate Cancer Targeted Therapy Groupen_US
dc.contributor.icrauthorDe Bono, Johannen
dc.contributor.icrauthorMarsden,en


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