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Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302).

Identifieur interne : 003365 ( PubMed/Corpus ); précédent : 003364; suivant : 003366

Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302).

Auteurs : Dana E. Rathkopf ; Matthew R. Smith ; Johann S. De Bono ; Christopher J. Logothetis ; Neal D. Shore ; Paul De Souza ; Karim Fizazi ; Peter F A. Mulders ; Paul Mainwaring ; John D. Hainsworth ; Tomasz M. Beer ; Scott North ; Yves Fradet ; Hendrik Van Poppel ; Joan Carles ; Thomas W. Flaig ; Eleni Efstathiou ; Evan Y. Yu ; Celestia S. Higano ; Mary-Ellen Taplin ; Thomas W. Griffin ; Mary B. Todd ; Margaret K. Yu ; Youn C. Park ; Thian Kheoh ; Eric J. Small ; Howard I. Scher ; Arturo Molina ; Charles J. Ryan ; Fred Saad

Source :

RBID : pubmed:24647231

English descriptors

Abstract

Abiraterone acetate (an androgen biosynthesis inhibitor) plus prednisone is approved for treating patients with metastatic castration-resistant prostate cancer (mCRPC). Study COU-AA-302 evaluated abiraterone acetate plus prednisone versus prednisone alone in mildly symptomatic or asymptomatic patients with progressive mCRPC without prior chemotherapy.

DOI: 10.1016/j.eururo.2014.02.056
PubMed: 24647231

Links to Exploration step

pubmed:24647231

Le document en format XML

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<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
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<name sortKey="Beer, Tomasz M" sort="Beer, Tomasz M" uniqKey="Beer T" first="Tomasz M" last="Beer">Tomasz M. Beer</name>
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<name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name>
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<name sortKey="Van Poppel, Hendrik" sort="Van Poppel, Hendrik" uniqKey="Van Poppel H" first="Hendrik" last="Van Poppel">Hendrik Van Poppel</name>
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<nlm:affiliation>University Hospital Leuven, Leuven, Belgium.</nlm:affiliation>
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<name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name>
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<name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
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<nlm:affiliation>MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
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<name sortKey="Yu, Evan Y" sort="Yu, Evan Y" uniqKey="Yu E" first="Evan Y" last="Yu">Evan Y. Yu</name>
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<name sortKey="Higano, Celestia S" sort="Higano, Celestia S" uniqKey="Higano C" first="Celestia S" last="Higano">Celestia S. Higano</name>
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<name sortKey="Taplin, Mary Ellen" sort="Taplin, Mary Ellen" uniqKey="Taplin M" first="Mary-Ellen" last="Taplin">Mary-Ellen Taplin</name>
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<nlm:affiliation>Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.</nlm:affiliation>
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<name sortKey="Griffin, Thomas W" sort="Griffin, Thomas W" uniqKey="Griffin T" first="Thomas W" last="Griffin">Thomas W. Griffin</name>
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<nlm:affiliation>Janssen Research & Development, Los Angeles, CA, USA.</nlm:affiliation>
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<name sortKey="Todd, Mary B" sort="Todd, Mary B" uniqKey="Todd M" first="Mary B" last="Todd">Mary B. Todd</name>
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<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
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<title xml:lang="en">Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302).</title>
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<nlm:affiliation>The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Sutton, Surrey, UK.</nlm:affiliation>
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<name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J" last="Logothetis">Christopher J. Logothetis</name>
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<nlm:affiliation>MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
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<name sortKey="Shore, Neal D" sort="Shore, Neal D" uniqKey="Shore N" first="Neal D" last="Shore">Neal D. Shore</name>
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<name sortKey="De Souza, Paul" sort="De Souza, Paul" uniqKey="De Souza P" first="Paul" last="De Souza">Paul De Souza</name>
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</affiliation>
</author>
<author>
<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
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<nlm:affiliation>Institut Gustave Roussy, University of Paris Sud, Villejuif, France.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Mulders, Peter F A" sort="Mulders, Peter F A" uniqKey="Mulders P" first="Peter F A" last="Mulders">Peter F A. Mulders</name>
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<nlm:affiliation>Radboud University Medical Centre, Nijmegen, The Netherlands.</nlm:affiliation>
</affiliation>
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<name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
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<nlm:affiliation>Hematology & Oncology Clinics of Australia, Brisbane, Australia.</nlm:affiliation>
</affiliation>
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<name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D" last="Hainsworth">John D. Hainsworth</name>
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<nlm:affiliation>Sarah Cannon Research Institute, Nashville, TN, USA.</nlm:affiliation>
</affiliation>
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<author>
<name sortKey="Beer, Tomasz M" sort="Beer, Tomasz M" uniqKey="Beer T" first="Tomasz M" last="Beer">Tomasz M. Beer</name>
<affiliation>
<nlm:affiliation>Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
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<nlm:affiliation>Cross Cancer Institute, Edmonton, Alberta, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name>
<affiliation>
<nlm:affiliation>Laval University, Québec City, Québec, Canada.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Van Poppel, Hendrik" sort="Van Poppel, Hendrik" uniqKey="Van Poppel H" first="Hendrik" last="Van Poppel">Hendrik Van Poppel</name>
<affiliation>
<nlm:affiliation>University Hospital Leuven, Leuven, Belgium.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name>
<affiliation>
<nlm:affiliation>Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W" last="Flaig">Thomas W. Flaig</name>
<affiliation>
<nlm:affiliation>University of Colorado Cancer Center and University of Colorado School of Medicine, Aurora, CO, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
<affiliation>
<nlm:affiliation>MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Yu, Evan Y" sort="Yu, Evan Y" uniqKey="Yu E" first="Evan Y" last="Yu">Evan Y. Yu</name>
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<nlm:affiliation>University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Higano, Celestia S" sort="Higano, Celestia S" uniqKey="Higano C" first="Celestia S" last="Higano">Celestia S. Higano</name>
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<nlm:affiliation>University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</nlm:affiliation>
</affiliation>
</author>
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<name sortKey="Taplin, Mary Ellen" sort="Taplin, Mary Ellen" uniqKey="Taplin M" first="Mary-Ellen" last="Taplin">Mary-Ellen Taplin</name>
<affiliation>
<nlm:affiliation>Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Griffin, Thomas W" sort="Griffin, Thomas W" uniqKey="Griffin T" first="Thomas W" last="Griffin">Thomas W. Griffin</name>
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<nlm:affiliation>Janssen Research & Development, Los Angeles, CA, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Todd, Mary B" sort="Todd, Mary B" uniqKey="Todd M" first="Mary B" last="Todd">Mary B. Todd</name>
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<nlm:affiliation>Janssen Research & Development, Raritan, NJ, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Yu, Margaret K" sort="Yu, Margaret K" uniqKey="Yu M" first="Margaret K" last="Yu">Margaret K. Yu</name>
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<name sortKey="Park, Youn C" sort="Park, Youn C" uniqKey="Park Y" first="Youn C" last="Park">Youn C. Park</name>
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<nlm:affiliation>Janssen Research & Development, Raritan, NJ, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
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<name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J" last="Small">Eric J. Small</name>
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<nlm:affiliation>Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I" last="Scher">Howard I. Scher</name>
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<nlm:affiliation>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.</nlm:affiliation>
</affiliation>
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<name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
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<nlm:affiliation>Janssen Research & Development, Menlo Park, CA, USA.</nlm:affiliation>
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<author>
<name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J" last="Ryan">Charles J. Ryan</name>
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<nlm:affiliation>Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.</nlm:affiliation>
</affiliation>
</author>
<author>
<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
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<nlm:affiliation>CRCHUM, University of Montréal, Montréal, Québec, Canada.</nlm:affiliation>
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<term>Abiraterone Acetate</term>
<term>Aged</term>
<term>Androstenes (administration & dosage)</term>
<term>Androstenes (adverse effects)</term>
<term>Antineoplastic Agents, Hormonal (administration & dosage)</term>
<term>Antineoplastic Agents, Hormonal (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Cytochrome P-450 Enzyme Inhibitors (administration & dosage)</term>
<term>Cytochrome P-450 Enzyme Inhibitors (adverse effects)</term>
<term>Disease Progression</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Drug Administration Schedule</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neoplasm Metastasis</term>
<term>Neoplasms, Hormone-Dependent (drug therapy)</term>
<term>Neoplasms, Hormone-Dependent (enzymology)</term>
<term>Neoplasms, Hormone-Dependent (mortality)</term>
<term>Neoplasms, Hormone-Dependent (pathology)</term>
<term>Prednisone (administration & dosage)</term>
<term>Proportional Hazards Models</term>
<term>Prostatic Neoplasms, Castration-Resistant (drug therapy)</term>
<term>Prostatic Neoplasms, Castration-Resistant (enzymology)</term>
<term>Prostatic Neoplasms, Castration-Resistant (mortality)</term>
<term>Prostatic Neoplasms, Castration-Resistant (pathology)</term>
<term>Risk Factors</term>
<term>Steroid 17-alpha-Hydroxylase (antagonists & inhibitors)</term>
<term>Steroid 17-alpha-Hydroxylase (metabolism)</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en">
<term>Androstenes</term>
<term>Antineoplastic Agents, Hormonal</term>
<term>Cytochrome P-450 Enzyme Inhibitors</term>
<term>Prednisone</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en">
<term>Androstenes</term>
<term>Antineoplastic Agents, Hormonal</term>
<term>Cytochrome P-450 Enzyme Inhibitors</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en">
<term>Steroid 17-alpha-Hydroxylase</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en">
<term>Steroid 17-alpha-Hydroxylase</term>
</keywords>
<keywords scheme="MESH" type="chemical" xml:lang="en">
<term>Abiraterone Acetate</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en">
<term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en">
<term>Neoplasms, Hormone-Dependent</term>
<term>Prostatic Neoplasms, Castration-Resistant</term>
</keywords>
<keywords scheme="MESH" qualifier="enzymology" xml:lang="en">
<term>Neoplasms, Hormone-Dependent</term>
<term>Prostatic Neoplasms, Castration-Resistant</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en">
<term>Neoplasms, Hormone-Dependent</term>
<term>Prostatic Neoplasms, Castration-Resistant</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en">
<term>Neoplasms, Hormone-Dependent</term>
<term>Prostatic Neoplasms, Castration-Resistant</term>
</keywords>
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<term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Aged</term>
<term>Disease Progression</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Drug Administration Schedule</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neoplasm Metastasis</term>
<term>Proportional Hazards Models</term>
<term>Risk Factors</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
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<front>
<div type="abstract" xml:lang="en">Abiraterone acetate (an androgen biosynthesis inhibitor) plus prednisone is approved for treating patients with metastatic castration-resistant prostate cancer (mCRPC). Study COU-AA-302 evaluated abiraterone acetate plus prednisone versus prednisone alone in mildly symptomatic or asymptomatic patients with progressive mCRPC without prior chemotherapy.</div>
</front>
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<PMID Version="1">24647231</PMID>
<DateCreated>
<Year>2015</Year>
<Month>02</Month>
<Day>02</Day>
</DateCreated>
<DateCompleted>
<Year>2015</Year>
<Month>11</Month>
<Day>02</Day>
</DateCompleted>
<DateRevised>
<Year>2016</Year>
<Month>12</Month>
<Day>15</Day>
</DateRevised>
<Article PubModel="Print-Electronic">
<Journal>
<ISSN IssnType="Electronic">1873-7560</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>66</Volume>
<Issue>5</Issue>
<PubDate>
<Year>2014</Year>
<Month>Nov</Month>
</PubDate>
</JournalIssue>
<Title>European urology</Title>
<ISOAbbreviation>Eur. Urol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302).</ArticleTitle>
<Pagination>
<MedlinePgn>815-25</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.eururo.2014.02.056</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0302-2838(14)00185-7</ELocationID>
<Abstract>
<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Abiraterone acetate (an androgen biosynthesis inhibitor) plus prednisone is approved for treating patients with metastatic castration-resistant prostate cancer (mCRPC). Study COU-AA-302 evaluated abiraterone acetate plus prednisone versus prednisone alone in mildly symptomatic or asymptomatic patients with progressive mCRPC without prior chemotherapy.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Report the prespecified third interim analysis (IA) of efficacy and safety outcomes in study COU-AA-302.</AbstractText>
<AbstractText Label="DESIGN, SETTING, AND PARTICIPANTS" NlmCategory="METHODS">Study COU-AA-302, a double-blind placebo-controlled study, enrolled patients with mCRPC from April 2009 to June 2010. A total of 1088 patients were stratified by Eastern Cooperative Oncology Group performance status (0 vs 1).</AbstractText>
<AbstractText Label="INTERVENTION" NlmCategory="METHODS">Patients were randomised 1:1 to abiraterone 1000mg plus prednisone 5mg twice daily by mouth versus prednisone.</AbstractText>
<AbstractText Label="OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS" NlmCategory="METHODS">Co-primary end points were radiographic progression-free survival (rPFS) and overall survival (OS). Median times to event outcomes were estimated using the Kaplan-Meier method. Hazard ratios (HRs) and 95% confidence intervals (CIs) were derived using the Cox model, and treatment comparison used the log-rank test. The O'Brien-Fleming Lan-DeMets α-spending function was used for OS. Adverse events were summarised descriptively.</AbstractText>
<AbstractText Label="RESULTS AND LIMITATIONS" NlmCategory="CONCLUSIONS">With a median follow-up duration of 27.1 mo, improvement in rPFS was statistically significant with abiraterone treatment versus prednisone (median: 16.5 vs 8.2 mo; HR: 0.52 [95% CI, 0.45-0.61]; p<0.0001). Abiraterone improved OS (median: 35.3 vs 30.1 mo; HR: 0.79 [95% CI, 0.66-0.95]; p=0.0151) but did not reach the prespecified statistical efficacy boundary (α-level: 0.0035). A post hoc multivariate analysis for OS using known prognostic factors supported the primary results (HR: 0.74 [95% CI, 0.61-0.89]; p=0.0017), and all clinically relevant secondary end points and patient-reported outcomes improved. While the post hoc nature of the long-term safety analysis is a limitation, the safety profile with longer treatment exposure was consistent with prior reports.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The updated IA of study COU-AA-302 in patients with mCRPC without prior chemotherapy confirms that abiraterone delays disease progression, pain, and functional deterioration and has clinical benefit with a favourable safety profile, including in patients treated for ≥24 mo.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Study COU-AA-302, ClinicalTrials.gov number, NCT00887198.</AbstractText>
<AbstractText Label="PATIENT SUMMARY" NlmCategory="RESULTS">The updated results of this ongoing study showed that disease progression was delayed in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone, and there was a continued trend in prolongation of life compared with patients treated with prednisone alone. Treatment with abiraterone acetate and prednisone was well tolerated by patients who were treated for >2 yr.</AbstractText>
<CopyrightInformation>Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.</CopyrightInformation>
</Abstract>
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<ForeName>Dana E</ForeName>
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<GrantID>K24 CA121990</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
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<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
</Grant>
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<GrantID>P30 CA069533</GrantID>
<Acronym>CA</Acronym>
<Agency>NCI NIH HHS</Agency>
<Country>United States</Country>
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<DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
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<MeshHeading>
<DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName>
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<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
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<Keyword MajorTopicYN="N">Metastatic castration-resistant prostate cancer</Keyword>
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<ArticleId IdType="doi">10.1016/j.eururo.2014.02.056</ArticleId>
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   |texte=   Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302).
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