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dc.contributor.authorSaad, Fen_US
dc.contributor.authorShore, Nen_US
dc.contributor.authorVan Poppel, Hen_US
dc.contributor.authorRathkopf, DEen_US
dc.contributor.authorSmith, MRen_US
dc.contributor.authorde Bono, JSen_US
dc.contributor.authorLogothetis, CJen_US
dc.contributor.authorde Souza, Pen_US
dc.contributor.authorFizazi, Ken_US
dc.contributor.authorMulders, PFAen_US
dc.contributor.authorMainwaring, Pen_US
dc.contributor.authorHainsworth, JDen_US
dc.contributor.authorBeer, TMen_US
dc.contributor.authorNorth, Sen_US
dc.contributor.authorFradet, Yen_US
dc.contributor.authorGriffin, TAen_US
dc.contributor.authorDe Porre, Pen_US
dc.contributor.authorLondhe, Aen_US
dc.contributor.authorKheoh, Ten_US
dc.contributor.authorSmall, EJen_US
dc.contributor.authorScher, HIen_US
dc.contributor.authorMolina, Aen_US
dc.contributor.authorRyan, CJen_US
dc.date.accessioned2018-07-31T15:14:15Z
dc.date.issued2015-10en_US
dc.identifier.citationEuropean urology, 2015, 68 (4), pp. 570 - 577en_US
dc.identifier.issn0302-2838en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2238
dc.identifier.eissn1873-7560en_US
dc.identifier.doi10.1016/j.eururo.2015.04.032en_US
dc.description.abstractMetastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy.Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients.This report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial.Patients were grouped by concomitant BTT use or no BTT use.Radiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and p values for concomitant BTT versus no BTT were obtained via Cox models.While the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; p=0.01) and increased the time to ECOG deterioration (HR 0.75; p<0.001) and time to opiate use for cancer-related pain (HR 0.80; p=0.036). The safety profile of concomitant BTT with AA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in <3% of patients.AA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT.Treatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone in combination with bone-targeted therapy, there was a continued trend in prolongation of life when compared with patients treated with prednisone alone.ClinicalTrials.gov NCT00887198.en_US
dc.formatPrint-Electronicen_US
dc.format.extent570 - 577en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://www.rioxx.net/licenses/all-rights-reserveden_US
dc.subjectHumansen_US
dc.subjectBone Neoplasmsen_US
dc.subjectPrednisoneen_US
dc.subjectAntineoplastic Agents, Hormonalen_US
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen_US
dc.subjectDisease-Free Survivalen_US
dc.subjectTreatment Outcomeen_US
dc.subjectProportional Hazards Modelsen_US
dc.subjectOdds Ratioen_US
dc.subjectRisk Factorsen_US
dc.subjectRetrospective Studiesen_US
dc.subjectTime Factorsen_US
dc.subjectAgeden_US
dc.subjectMiddle Ageden_US
dc.subjectMaleen_US
dc.subjectBone Density Conservation Agentsen_US
dc.subjectMulticenter Studies as Topicen_US
dc.subjectRandomized Controlled Trials as Topicen_US
dc.subjectClinical Trials, Phase III as Topicen_US
dc.subjectKaplan-Meier Estimateen_US
dc.subjectBisphosphonate-Associated Osteonecrosis of the Jawen_US
dc.subjectProstatic Neoplasms, Castration-Resistanten_US
dc.subjectSteroid Synthesis Inhibitorsen_US
dc.subjectAbiraterone Acetateen_US
dc.titleImpact of bone-targeted therapies in chemotherapy-naïve metastatic castration-resistant prostate cancer patients treated with abiraterone acetate: post hoc analysis of study COU-AA-302.en_US
dc.typeJournal Article
dcterms.dateAccepted2015-04-21en_US
rioxxterms.versionofrecord10.1016/j.eururo.2015.04.032en_US
rioxxterms.licenseref.startdate2015-10en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfEuropean urologyen_US
pubs.issue4en_US
pubs.notesNot knownen_US
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-statusPublisheden_US
pubs.volume68en_US
pubs.embargo.termsNot knownen_US
icr.researchteamProstate Cancer Targeted Therapy Groupen_US
dc.contributor.icrauthorDe Bono, Johannen_US


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