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dc.contributor.authorEvans, CP
dc.contributor.authorHigano, CS
dc.contributor.authorKeane, T
dc.contributor.authorAndriole, G
dc.contributor.authorSaad, F
dc.contributor.authorIversen, P
dc.contributor.authorMiller, K
dc.contributor.authorKim, C-S
dc.contributor.authorKimura, G
dc.contributor.authorArmstrong, AJ
dc.contributor.authorSternberg, CN
dc.contributor.authorLoriot, Y
dc.contributor.authorde Bono, J
dc.contributor.authorNoonberg, SB
dc.contributor.authorMansbach, H
dc.contributor.authorBhattacharya, S
dc.contributor.authorPerabo, F
dc.contributor.authorBeer, TM
dc.contributor.authorTombal, B
dc.date.accessioned2017-03-01T15:43:21Z
dc.date.issued2016-10
dc.identifier.citationEuropean urology, 2016, 70 (4), pp. 675 - 683
dc.identifier.issn0302-2838
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/458
dc.identifier.eissn1873-7560
dc.identifier.doi10.1016/j.eururo.2016.03.017
dc.description.abstractBackground Enzalutamide, an oral androgen receptor inhibitor, significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) versus placebo in the PREVAIL trial of men with chemotherapy-naïve metastatic castration-resistant prostate cancer.Objective To assess the effects of enzalutamide versus placebo in patients from PREVAIL based on site and extent of baseline disease.Design, setting, and participants One thousand seven hundred and seventeen asymptomatic or minimally symptomatic patients were randomized to enzalutamide (n=872) or placebo (n=845). Subgroup analyses included nonvisceral (only bone and/or nodal; n=1513), visceral (lung and/or liver; n=204), low-volume bone disease (<4 bone metastases; n=867), high-volume bone disease (≥4 bone metastases; n=850), lymph node only disease (n=195).Intervention Oral enzalutamide (160mg) or placebo once daily while continuing androgen deprivation therapy.Outcome measurements and statistical analysis Coprimary endpoints (rPFS, OS) were prospectively evaluated in nonvisceral and visceral subgroups. All other efficacy analyses were post hoc.Results and limitations Enzalutamide improved rPFS versus placebo in patients with nonvisceral disease (hazard ratio [HR], 0.18; 95% confidence interval [CI], 0.14-0.22), visceral disease (HR, 0.28; 95% CI, 0.16-0.49), low- or high-volume bone disease (HR, 0.16; 95% CI, 0.11-0.22; HR, 0.22; 95% CI, 0.16-0.29, respectively), and lymph node only disease (HR, 0.09; 95% CI, 0.04-0.19). For OS, HRs favored enzalutamide (<1) across all disease subgroups, although 95% CI was >1 in patients with visceral disease (HR, 0.82; 95% CI, 0.55-1.23). Enzalutamide was well tolerated in patients with or without visceral disease.Conclusions Enzalutamide provided clinically significant benefits in men with chemotherapy-naïve metastatic castration-resistant prostate cancer, with or without visceral disease, low- or high-volume bone disease, or lymph node only disease.Patient summary Patients with metastatic castration-resistant prostate cancer-including those with or without visceral disease or widespread bone disease-benefitted from enzalutamide, an active well-tolerated therapy.
dc.formatPrint-Electronic
dc.format.extent675 - 683
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved
dc.subjectHumans
dc.subjectBone Neoplasms
dc.subjectLiver Neoplasms
dc.subjectLung Neoplasms
dc.subjectLymphatic Metastasis
dc.subjectPhenylthiohydantoin
dc.subjectAntineoplastic Agents
dc.subjectDisease-Free Survival
dc.subjectTumor Burden
dc.subjectSurvival Rate
dc.subjectProspective Studies
dc.subjectDouble-Blind Method
dc.subjectAged
dc.subjectMale
dc.subjectAndrogen Receptor Antagonists
dc.subjectProstatic Neoplasms, Castration-Resistant
dc.titleThe PREVAIL Study: Primary Outcomes by Site and Extent of Baseline Disease for Enzalutamide-treated Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer.
dc.typeJournal Article
dcterms.dateAccepted2016-03-04
rioxxterms.versionofrecord10.1016/j.eururo.2016.03.017
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2016-10
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfEuropean urology
pubs.issue4
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
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.publication-statusPublished
pubs.volume70
pubs.embargo.termsNot known
icr.researchteamProstate Cancer Targeted Therapy Groupen_US
dc.contributor.icrauthorDe Bono, Johannen


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