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 : 003F03 ( Main/Exploration ); précédent : 003F02; suivant : 003F04Updated 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 [États-Unis] ; Matthew R. Smith [États-Unis] ; Johann S. De Bono [Royaume-Uni] ; Christopher J. Logothetis [États-Unis] ; Neal D. Shore [États-Unis] ; Paul De Souza [Australie] ; Karim Fizazi [France] ; Peter F. A. Mulders [Pays-Bas] ; Paul Mainwaring [Australie] ; John D. Hainsworth [États-Unis] ; Tomasz M. Beer [États-Unis] ; Scott North [Canada] ; Yves Fradet [Canada] ; Hendrik Van Poppel [Belgique] ; Joan Carles [Espagne] ; Thomas W. Flaig [États-Unis] ; Eleni Efstathiou [États-Unis] ; Evan Y. Yu [États-Unis] ; Celestia S. Higano [États-Unis] ; Mary-Ellen Taplin [États-Unis] ; Thomas W. Griffin [États-Unis] ; Mary B. Todd [États-Unis] ; Margaret K. Yu [États-Unis] ; Youn C. Park [États-Unis] ; THIAN KHEOH [États-Unis] ; Eric J. Small [États-Unis] ; Howard I. Scher [États-Unis] ; Arturo Molina [États-Unis] ; Charles J. Ryan [États-Unis] ; Fred Saad [Canada]Source :
- European urology [ 0302-2838 ] ; 2014.
Descripteurs français
- KwdFr :
- Acétate d'abiratérone, Adulte d'âge moyen, Androstènes (administration et posologie), Androstènes (effets indésirables), Antinéoplasiques hormonaux (administration et posologie), Antinéoplasiques hormonaux (effets indésirables), Calendrier d'administration des médicaments, Estimation de Kaplan-Meier, Facteurs de risque, Facteurs temps, Humains, Inhibiteurs des enzymes du cytochrome P-450 (administration et posologie), Inhibiteurs des enzymes du cytochrome P-450 (effets indésirables), Modèles de hasards proportionnels, Mâle, Métastase tumorale, Méthode en double aveugle, Prednisone (administration et posologie), Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Résultat thérapeutique, Steroid 17-alpha-hydroxylase (antagonistes et inhibiteurs), Steroid 17-alpha-hydroxylase (métabolisme), Sujet âgé, Survie sans rechute, Tumeurs hormonodépendantes (anatomopathologie), Tumeurs hormonodépendantes (enzymologie), Tumeurs hormonodépendantes (mortalité), Tumeurs hormonodépendantes (traitement médicamenteux), Tumeurs prostatiques résistantes à la castration (anatomopathologie), Tumeurs prostatiques résistantes à la castration (enzymologie), Tumeurs prostatiques résistantes à la castration (mortalité), Tumeurs prostatiques résistantes à la castration (traitement médicamenteux), Évolution de la maladie.
- MESH :
- administration et posologie : Androstènes, Antinéoplasiques hormonaux, Inhibiteurs des enzymes du cytochrome P-450, Prednisone.
- anatomopathologie : Tumeurs hormonodépendantes, Tumeurs prostatiques résistantes à la castration.
- antagonistes et inhibiteurs : Steroid 17-alpha-hydroxylase.
- effets indésirables : Androstènes, Antinéoplasiques hormonaux, Inhibiteurs des enzymes du cytochrome P-450, Protocoles de polychimiothérapie antinéoplasique.
- enzymologie : Tumeurs hormonodépendantes, Tumeurs prostatiques résistantes à la castration.
- mortalité : Tumeurs hormonodépendantes, Tumeurs prostatiques résistantes à la castration.
- métabolisme : Steroid 17-alpha-hydroxylase.
- traitement médicamenteux : Tumeurs hormonodépendantes, Tumeurs prostatiques résistantes à la castration.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Pascal (Inist)
- Abiratérone, Acétate d'abiratérone, Adulte d'âge moyen, Calendrier d'administration des médicaments, Efficacité traitement, Estimation de Kaplan-Meier, Facteurs de risque, Facteurs temps, Humains, Long terme, Modèles de hasards proportionnels, Mâle, Métastase, Métastase tumorale, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Survie sans rechute, Toxicité, Acétate, Cancer de la prostate, Métastatique, Stade avancé, Castration, Résistance, Homme, Chimiothérapie, Néphrologie, Urologie, Évolution de la maladie.
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Abiraterone, Abiraterone Acetate, Acetate, Advanced stage, Aged, Androstenes (administration & dosage), Androstenes (adverse effects), Antineoplastic Agents, Hormonal (administration & dosage), Antineoplastic Agents, Hormonal (adverse effects), Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Castration, Chemotherapy, Cytochrome P-450 Enzyme Inhibitors (administration & dosage), Cytochrome P-450 Enzyme Inhibitors (adverse effects), Disease Progression, Disease-Free Survival, Double-Blind Method, Drug Administration Schedule, Human, Humans, Kaplan-Meier Estimate, Long term, Male, Metastasis, Metastatic, Middle Aged, Neoplasm Metastasis, Neoplasms, Hormone-Dependent (drug therapy), Neoplasms, Hormone-Dependent (enzymology), Neoplasms, Hormone-Dependent (mortality), Neoplasms, Hormone-Dependent (pathology), Nephrology, Prednisone (administration & dosage), Proportional Hazards Models, Prostate cancer, Prostatic Neoplasms, Castration-Resistant (drug therapy), Prostatic Neoplasms, Castration-Resistant (enzymology), Prostatic Neoplasms, Castration-Resistant (mortality), Prostatic Neoplasms, Castration-Resistant (pathology), Resistance, Risk Factors, Steroid 17-alpha-Hydroxylase (antagonists & inhibitors), Steroid 17-alpha-Hydroxylase (metabolism), Time Factors, Toxicity, Treatment Outcome, Treatment efficiency, Urology.
- MESH :
- chemical , administration & dosage : Androstenes, Antineoplastic Agents, Hormonal, Cytochrome P-450 Enzyme Inhibitors, Prednisone.
- chemical , adverse effects : Androstenes, Antineoplastic Agents, Hormonal, Cytochrome P-450 Enzyme Inhibitors.
- chemical , antagonists & inhibitors : Steroid 17-alpha-Hydroxylase.
- chemical , metabolism : Steroid 17-alpha-Hydroxylase.
- chemical : Abiraterone Acetate.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- drug therapy : Neoplasms, Hormone-Dependent, Prostatic Neoplasms, Castration-Resistant.
- enzymology : Neoplasms, Hormone-Dependent, Prostatic Neoplasms, Castration-Resistant.
- mortality : Neoplasms, Hormone-Dependent, Prostatic Neoplasms, Castration-Resistant.
- pathology : Neoplasms, Hormone-Dependent, Prostatic Neoplasms, Castration-Resistant.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Aged, Disease Progression, Disease-Free Survival, Double-Blind Method, Drug Administration Schedule, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Metastasis, Proportional Hazards Models, Risk Factors, Time Factors, Treatment Outcome.
Abstract
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. Objective: Report the prespecified third interim analysis (IA) of efficacy and safety outcomes in study COU-AA-302. Design, setting, and participants: 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).
Url:
Affiliations:
- Australie, Belgique, Canada, Espagne, France, Pays-Bas, Royaume-Uni, États-Unis
- Catalogne, Gueldre, Washington (État)
- Barcelone, Nimègue, Seattle
- Université de Washington
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Le document en format XML
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<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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<author><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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<author><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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<author><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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<author><name sortKey="Thian Kheoh" sort="Thian Kheoh" uniqKey="Thian Kheoh" last="Thian Kheoh">THIAN KHEOH</name>
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<author><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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<author><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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</affiliation>
</author>
<author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
<affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Janssen Research & Development</s1>
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<s3>USA</s3>
<sZ>28 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Janssen Research & Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J." last="Ryan">Charles J. Ryan</name>
<affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Helen Diller Family Comprehensive Cancer Center, University of California</s1>
<s2>San Francisco, CA</s2>
<s3>USA</s3>
<sZ>26 aut.</sZ>
<sZ>29 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>San Francisco, CA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
<affiliation wicri:level="1"><inist:fA14 i1="23"><s1>CRCHUM, University of Montreal</s1>
<s2>Montreal, Québec</s2>
<s3>CAN</s3>
<sZ>30 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Montreal, Québec</wicri:noRegion>
</affiliation>
</author>
</titleStmt>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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>
<author><name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E." last="Rathkopf">Dana E. Rathkopf</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>27 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Smith, Matthew R" sort="Smith, Matthew R" uniqKey="Smith M" first="Matthew R." last="Smith">Matthew R. Smith</name>
<affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Harvard Medical School and Massachusetts General Hospital</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Harvard Medical School and Massachusetts General Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S." last="De Bono">Johann S. De Bono</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>The Institute of Cancer Research and Royal Marsden NHS Foundation Trust</s1>
<s2>Sutton, Surrey</s2>
<s3>GBR</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>The Institute of Cancer Research and Royal Marsden NHS Foundation Trust</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>MD Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>MD Anderson Cancer Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Shore, Neal D" sort="Shore, Neal D" uniqKey="Shore N" first="Neal D." last="Shore">Neal D. Shore</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Carolina Urologic Research Center, Atlantic Urology Clinics</s1>
<s2>Myrtle Beach, SC</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Myrtle Beach, SC</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="De Souza, Paul" sort="De Souza, Paul" uniqKey="De Souza P" first="Paul" last="De Souza">Paul De Souza</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>University of Western Sydney School of Medicine</s1>
<s2>Penrith</s2>
<s3>AUS</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>University of Western Sydney School of Medicine</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Institut Gustave Roussy, University of Paris Sud</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>Villejuif</wicri:noRegion>
<wicri:noRegion>University of Paris Sud</wicri:noRegion>
<wicri:noRegion>Villejuif</wicri:noRegion>
</affiliation>
</author>
<author><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>
<affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Radboud University Medical Centre</s1>
<s2>Nijmegen</s2>
<s3>NLD</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName><settlement type="city">Nimègue</settlement>
<region type="province" nuts="2">Gueldre</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
<affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Hematology & Oncology Clinics of Australia</s1>
<s2>Brisbane</s2>
<s3>AUS</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Hematology & Oncology Clinics of Australia</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D." last="Hainsworth">John D. Hainsworth</name>
<affiliation wicri:level="1"><inist:fA14 i1="10"><s1>Sarah Cannon Research Institute</s1>
<s2>Nashville, TN</s2>
<s3>USA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Sarah Cannon Research Institute</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Beer, Tomasz M" sort="Beer, Tomasz M" uniqKey="Beer T" first="Tomasz M." last="Beer">Tomasz M. Beer</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Oregon Health & Science University Knight Cancer Institute</s1>
<s2>Portland, OR</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Oregon Health & Science University Knight Cancer Institute</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Cross Cancer Institute</s1>
<s2>Edmonton, Alberta</s2>
<s3>CAN</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Cross Cancer Institute</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Laval University</s1>
<s2>Quebec City, Québec</s2>
<s3>CAN</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Laval University</wicri:noRegion>
</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 wicri:level="1"><inist:fA14 i1="14"><s1>University Hospital Leuven</s1>
<s2>Leuven</s2>
<s3>BEL</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Belgique</country>
<wicri:noRegion>University Hospital Leuven</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Hospital Universitari Vail d'Hebron, Universitat Autònoma de Barcelona</s1>
<s2>Barcelona</s2>
<s3>ESP</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</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 wicri:level="1"><inist:fA14 i1="16"><s1>University of Colorado Cancer Center and University of Colorado School of Medicine</s1>
<s2>Aurora, CO</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>University of Colorado Cancer Center and University of Colorado School of Medicine</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>MD Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>4 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>MD Anderson Cancer Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Yu, Evan Y" sort="Yu, Evan Y" uniqKey="Yu E" first="Evan Y." last="Yu">Evan Y. Yu</name>
<affiliation wicri:level="4"><inist:fA14 i1="17"><s1>University of Washington, Fred Hutchinson Cancer Research Center</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Seattle, WA</wicri:noRegion>
<orgName type="university">Université de Washington</orgName>
<placeName><settlement type="city">Seattle</settlement>
<region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Higano, Celestia S" sort="Higano, Celestia S" uniqKey="Higano C" first="Celestia S." last="Higano">Celestia S. Higano</name>
<affiliation wicri:level="4"><inist:fA14 i1="17"><s1>University of Washington, Fred Hutchinson Cancer Research Center</s1>
<s2>Seattle, WA</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Seattle, WA</wicri:noRegion>
<orgName type="university">Université de Washington</orgName>
<placeName><settlement type="city">Seattle</settlement>
<region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Taplin, Mary Ellen" sort="Taplin, Mary Ellen" uniqKey="Taplin M" first="Mary-Ellen" last="Taplin">Mary-Ellen Taplin</name>
<affiliation wicri:level="1"><inist:fA14 i1="18"><s1>Dana-Farber Cancer Institute, Harvard Medical School</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Boston, MA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Griffin, Thomas W" sort="Griffin, Thomas W" uniqKey="Griffin T" first="Thomas W." last="Griffin">Thomas W. Griffin</name>
<affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Janssen Research & Development</s1>
<s2>Los Angeles, CA</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>23 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Janssen Research & Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Todd, Mary B" sort="Todd, Mary B" uniqKey="Todd M" first="Mary B." last="Todd">Mary B. Todd</name>
<affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Janssen Research & Development</s1>
<s2>Raritan, NJ</s2>
<s3>USA</s3>
<sZ>22 aut.</sZ>
<sZ>24 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Janssen Research & Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Yu, Margaret K" sort="Yu, Margaret K" uniqKey="Yu M" first="Margaret K." last="Yu">Margaret K. Yu</name>
<affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Janssen Research & Development</s1>
<s2>Los Angeles, CA</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>23 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Janssen Research & Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Park, Youn C" sort="Park, Youn C" uniqKey="Park Y" first="Youn C." last="Park">Youn C. Park</name>
<affiliation wicri:level="1"><inist:fA14 i1="20"><s1>Janssen Research & Development</s1>
<s2>Raritan, NJ</s2>
<s3>USA</s3>
<sZ>22 aut.</sZ>
<sZ>24 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Janssen Research & Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Thian Kheoh" sort="Thian Kheoh" uniqKey="Thian Kheoh" last="Thian Kheoh">THIAN KHEOH</name>
<affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Janssen Research & Development</s1>
<s2>Los Angeles, CA</s2>
<s3>USA</s3>
<sZ>21 aut.</sZ>
<sZ>23 aut.</sZ>
<sZ>25 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Janssen Research & Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J." last="Small">Eric J. Small</name>
<affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Helen Diller Family Comprehensive Cancer Center, University of California</s1>
<s2>San Francisco, CA</s2>
<s3>USA</s3>
<sZ>26 aut.</sZ>
<sZ>29 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>San Francisco, CA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College</s1>
<s2>New York, NY</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>27 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
<affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Janssen Research & Development</s1>
<s2>Menlo Park, CA</s2>
<s3>USA</s3>
<sZ>28 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Janssen Research & Development</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J." last="Ryan">Charles J. Ryan</name>
<affiliation wicri:level="1"><inist:fA14 i1="21"><s1>Helen Diller Family Comprehensive Cancer Center, University of California</s1>
<s2>San Francisco, CA</s2>
<s3>USA</s3>
<sZ>26 aut.</sZ>
<sZ>29 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>San Francisco, CA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
<affiliation wicri:level="1"><inist:fA14 i1="23"><s1>CRCHUM, University of Montreal</s1>
<s2>Montreal, Québec</s2>
<s3>CAN</s3>
<sZ>30 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Montreal, Québec</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">European urology</title>
<title level="j" type="abbreviated">Eur. urol.</title>
<idno type="ISSN">0302-2838</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">European urology</title>
<title level="j" type="abbreviated">Eur. urol.</title>
<idno type="ISSN">0302-2838</idno>
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</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abiraterone</term>
<term>Abiraterone Acetate</term>
<term>Acetate</term>
<term>Advanced stage</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>Castration</term>
<term>Chemotherapy</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>Human</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
<term>Long term</term>
<term>Male</term>
<term>Metastasis</term>
<term>Metastatic</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>Nephrology</term>
<term>Prednisone (administration & dosage)</term>
<term>Proportional Hazards Models</term>
<term>Prostate cancer</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>Resistance</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>Toxicity</term>
<term>Treatment Outcome</term>
<term>Treatment efficiency</term>
<term>Urology</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Acétate d'abiratérone</term>
<term>Adulte d'âge moyen</term>
<term>Androstènes (administration et posologie)</term>
<term>Androstènes (effets indésirables)</term>
<term>Antinéoplasiques hormonaux (administration et posologie)</term>
<term>Antinéoplasiques hormonaux (effets indésirables)</term>
<term>Calendrier d'administration des médicaments</term>
<term>Estimation de Kaplan-Meier</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>Humains</term>
<term>Inhibiteurs des enzymes du cytochrome P-450 (administration et posologie)</term>
<term>Inhibiteurs des enzymes du cytochrome P-450 (effets indésirables)</term>
<term>Modèles de hasards proportionnels</term>
<term>Mâle</term>
<term>Métastase tumorale</term>
<term>Méthode en double aveugle</term>
<term>Prednisone (administration et posologie)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term>
<term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term>
<term>Résultat thérapeutique</term>
<term>Steroid 17-alpha-hydroxylase (antagonistes et inhibiteurs)</term>
<term>Steroid 17-alpha-hydroxylase (métabolisme)</term>
<term>Sujet âgé</term>
<term>Survie sans rechute</term>
<term>Tumeurs hormonodépendantes (anatomopathologie)</term>
<term>Tumeurs hormonodépendantes (enzymologie)</term>
<term>Tumeurs hormonodépendantes (mortalité)</term>
<term>Tumeurs hormonodépendantes (traitement médicamenteux)</term>
<term>Tumeurs prostatiques résistantes à la castration (anatomopathologie)</term>
<term>Tumeurs prostatiques résistantes à la castration (enzymologie)</term>
<term>Tumeurs prostatiques résistantes à la castration (mortalité)</term>
<term>Tumeurs prostatiques résistantes à la castration (traitement médicamenteux)</term>
<term>Évolution de la maladie</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="administration et posologie" xml:lang="fr"><term>Androstènes</term>
<term>Antinéoplasiques hormonaux</term>
<term>Inhibiteurs des enzymes du cytochrome P-450</term>
<term>Prednisone</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Tumeurs hormonodépendantes</term>
<term>Tumeurs prostatiques résistantes à la castration</term>
</keywords>
<keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Steroid 17-alpha-hydroxylase</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="effets indésirables" xml:lang="fr"><term>Androstènes</term>
<term>Antinéoplasiques hormonaux</term>
<term>Inhibiteurs des enzymes du cytochrome P-450</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
</keywords>
<keywords scheme="MESH" qualifier="enzymologie" xml:lang="fr"><term>Tumeurs hormonodépendantes</term>
<term>Tumeurs prostatiques résistantes à la castration</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="mortalité" xml:lang="fr"><term>Tumeurs hormonodépendantes</term>
<term>Tumeurs prostatiques résistantes à la castration</term>
</keywords>
<keywords scheme="MESH" qualifier="métabolisme" xml:lang="fr"><term>Steroid 17-alpha-hydroxylase</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Neoplasms, Hormone-Dependent</term>
<term>Prostatic Neoplasms, Castration-Resistant</term>
</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs hormonodépendantes</term>
<term>Tumeurs prostatiques résistantes à la castration</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</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>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Abiratérone</term>
<term>Acétate d'abiratérone</term>
<term>Adulte d'âge moyen</term>
<term>Calendrier d'administration des médicaments</term>
<term>Efficacité traitement</term>
<term>Estimation de Kaplan-Meier</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>Humains</term>
<term>Long terme</term>
<term>Modèles de hasards proportionnels</term>
<term>Mâle</term>
<term>Métastase</term>
<term>Métastase tumorale</term>
<term>Méthode en double aveugle</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Survie sans rechute</term>
<term>Toxicité</term>
<term>Acétate</term>
<term>Cancer de la prostate</term>
<term>Métastatique</term>
<term>Stade avancé</term>
<term>Castration</term>
<term>Résistance</term>
<term>Homme</term>
<term>Chimiothérapie</term>
<term>Néphrologie</term>
<term>Urologie</term>
<term>Évolution de la maladie</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">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. Objective: Report the prespecified third interim analysis (IA) of efficacy and safety outcomes in study COU-AA-302. Design, setting, and participants: 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).</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Catalogne</li>
<li>Gueldre</li>
<li>Washington (État)</li>
</region>
<settlement><li>Barcelone</li>
<li>Nimègue</li>
<li>Seattle</li>
</settlement>
<orgName><li>Université de Washington</li>
</orgName>
</list>
<tree><country name="États-Unis"><noRegion><name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E." last="Rathkopf">Dana E. Rathkopf</name>
</noRegion>
<name sortKey="Beer, Tomasz M" sort="Beer, Tomasz M" uniqKey="Beer T" first="Tomasz M." last="Beer">Tomasz M. Beer</name>
<name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
<name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name>
<name sortKey="Griffin, Thomas W" sort="Griffin, Thomas W" uniqKey="Griffin T" first="Thomas W." last="Griffin">Thomas W. Griffin</name>
<name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D." last="Hainsworth">John D. Hainsworth</name>
<name sortKey="Higano, Celestia S" sort="Higano, Celestia S" uniqKey="Higano C" first="Celestia S." last="Higano">Celestia S. Higano</name>
<name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name>
<name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
<name sortKey="Park, Youn C" sort="Park, Youn C" uniqKey="Park Y" first="Youn C." last="Park">Youn C. Park</name>
<name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J." last="Ryan">Charles J. Ryan</name>
<name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name>
<name sortKey="Shore, Neal D" sort="Shore, Neal D" uniqKey="Shore N" first="Neal D." last="Shore">Neal D. Shore</name>
<name sortKey="Small, Eric J" sort="Small, Eric J" uniqKey="Small E" first="Eric J." last="Small">Eric J. Small</name>
<name sortKey="Smith, Matthew R" sort="Smith, Matthew R" uniqKey="Smith M" first="Matthew R." last="Smith">Matthew R. Smith</name>
<name sortKey="Taplin, Mary Ellen" sort="Taplin, Mary Ellen" uniqKey="Taplin M" first="Mary-Ellen" last="Taplin">Mary-Ellen Taplin</name>
<name sortKey="Thian Kheoh" sort="Thian Kheoh" uniqKey="Thian Kheoh" last="Thian Kheoh">THIAN KHEOH</name>
<name sortKey="Todd, Mary B" sort="Todd, Mary B" uniqKey="Todd M" first="Mary B." last="Todd">Mary B. Todd</name>
<name sortKey="Yu, Evan Y" sort="Yu, Evan Y" uniqKey="Yu E" first="Evan Y." last="Yu">Evan Y. Yu</name>
<name sortKey="Yu, Margaret K" sort="Yu, Margaret K" uniqKey="Yu M" first="Margaret K." last="Yu">Margaret K. Yu</name>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S." last="De Bono">Johann S. De Bono</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="De Souza, Paul" sort="De Souza, Paul" uniqKey="De Souza P" first="Paul" last="De Souza">Paul De Souza</name>
</noRegion>
<name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
</country>
<country name="France"><noRegion><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
</noRegion>
</country>
<country name="Pays-Bas"><region name="Gueldre"><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>
</region>
</country>
<country name="Canada"><noRegion><name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
</noRegion>
<name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name>
<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
</country>
<country name="Belgique"><noRegion><name sortKey="Van Poppel, Hendrik" sort="Van Poppel, Hendrik" uniqKey="Van Poppel H" first="Hendrik" last="Van Poppel">Hendrik Van Poppel</name>
</noRegion>
</country>
<country name="Espagne"><region name="Catalogne"><name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name>
</region>
</country>
</tree>
</affiliations>
</record>
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