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 : 003254 ( PubMed/Curation ); précédent : 003253; suivant : 003255Updated 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 [ 1873-7560 ] ; 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.
- Acétate d'abiratérone, Adulte d'âge moyen, Calendrier d'administration des médicaments, Estimation de Kaplan-Meier, Facteurs de risque, Facteurs temps, Humains, Modèles de hasards proportionnels, Mâle, Métastase tumorale, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Survie sans rechute, Évolution de la maladie.
English descriptors
- KwdEn :
- Abiraterone Acetate, 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), 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, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Metastasis, Neoplasms, Hormone-Dependent (drug therapy), Neoplasms, Hormone-Dependent (enzymology), Neoplasms, Hormone-Dependent (mortality), Neoplasms, Hormone-Dependent (pathology), Prednisone (administration & dosage), Proportional Hazards Models, Prostatic Neoplasms, Castration-Resistant (drug therapy), Prostatic Neoplasms, Castration-Resistant (enzymology), Prostatic Neoplasms, Castration-Resistant (mortality), Prostatic Neoplasms, Castration-Resistant (pathology), Risk Factors, Steroid 17-alpha-Hydroxylase (antagonists & inhibitors), Steroid 17-alpha-Hydroxylase (metabolism), Time Factors, Treatment Outcome.
- 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
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
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pubmed:24647231Le document en format XML
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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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<author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
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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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<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA</wicri:regionArea>
</affiliation>
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<author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
<affiliation wicri:level="1"><nlm:affiliation>CRCHUM, University of Montréal, Montréal, Québec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>CRCHUM, University of Montréal, Montréal, Québec</wicri:regionArea>
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<sourceDesc><biblStruct><analytic><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>
<author><name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E" last="Rathkopf">Dana E. Rathkopf</name>
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</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"><nlm:affiliation>Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA.</nlm:affiliation>
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</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>
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<author><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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<author><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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<author><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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<author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
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</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="1"><nlm:affiliation>Radboud University Medical Centre, Nijmegen, The Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Radboud University Medical Centre, Nijmegen</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
<affiliation wicri:level="1"><nlm:affiliation>Hematology & Oncology Clinics of Australia, Brisbane, Australia.</nlm:affiliation>
<country xml:lang="fr">Australie</country>
<wicri:regionArea>Hematology & Oncology Clinics of Australia, Brisbane</wicri:regionArea>
</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"><nlm:affiliation>Sarah Cannon Research Institute, Nashville, TN, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Sarah Cannon Research Institute, Nashville, TN</wicri:regionArea>
</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"><nlm:affiliation>Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Oregon Health & Science University Knight Cancer Institute, Portland, OR</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
<affiliation wicri:level="1"><nlm:affiliation>Cross Cancer Institute, Edmonton, Alberta, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Cross Cancer Institute, Edmonton, Alberta</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name>
<affiliation wicri:level="1"><nlm:affiliation>Laval University, Québec City, Québec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>Laval University, Québec City, Québec</wicri:regionArea>
</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"><nlm:affiliation>University Hospital Leuven, Leuven, Belgium.</nlm:affiliation>
<country xml:lang="fr">Belgique</country>
<wicri:regionArea>University Hospital Leuven, Leuven</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name>
<affiliation wicri:level="1"><nlm:affiliation>Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona</wicri:regionArea>
</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"><nlm:affiliation>University of Colorado Cancer Center and University of Colorado School of Medicine, Aurora, CO, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Colorado Cancer Center and University of Colorado School of Medicine, Aurora, CO</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
<affiliation wicri:level="1"><nlm:affiliation>MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>MD Anderson Cancer Center, Houston, TX</wicri:regionArea>
</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="1"><nlm:affiliation>University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA</wicri:regionArea>
</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="1"><nlm:affiliation>University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Washington, Fred Hutchinson Cancer Research Center, Seattle, WA</wicri:regionArea>
</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"><nlm:affiliation>Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA</wicri:regionArea>
</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"><nlm:affiliation>Janssen Research & Development, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research & Development, Los Angeles, CA</wicri:regionArea>
</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"><nlm:affiliation>Janssen Research & Development, Raritan, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research & Development, Raritan, NJ</wicri:regionArea>
</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"><nlm:affiliation>Janssen Research & Development, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research & Development, Los Angeles, CA</wicri:regionArea>
</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"><nlm:affiliation>Janssen Research & Development, Raritan, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research & Development, Raritan, NJ</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
<affiliation wicri:level="1"><nlm:affiliation>Janssen Research & Development, Los Angeles, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research & Development, Los Angeles, CA</wicri:regionArea>
</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"><nlm:affiliation>Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA</wicri:regionArea>
</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"><nlm:affiliation>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
<affiliation wicri:level="1"><nlm:affiliation>Janssen Research & Development, Menlo Park, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Janssen Research & Development, Menlo Park, CA</wicri:regionArea>
</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"><nlm:affiliation>Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, CA</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
<affiliation wicri:level="1"><nlm:affiliation>CRCHUM, University of Montréal, Montréal, Québec, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>CRCHUM, University of Montréal, Montréal, Québec</wicri:regionArea>
</affiliation>
</author>
</analytic>
<series><title level="j">European urology</title>
<idno type="eISSN">1873-7560</idno>
<imprint><date when="2014" type="published">2014</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><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="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>
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<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>
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<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>
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</keywords>
<keywords scheme="MESH" type="chemical" qualifier="metabolism" xml:lang="en"><term>Steroid 17-alpha-Hydroxylase</term>
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<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>
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<term>Antinéoplasiques hormonaux</term>
<term>Inhibiteurs des enzymes du cytochrome P-450</term>
<term>Protocoles de polychimiothérapie antinéoplasique</term>
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<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>
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<term>Tumeurs prostatiques résistantes à la castration</term>
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<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="MESH" xml:lang="fr"><term>Acétate d'abiratérone</term>
<term>Adulte d'âge moyen</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>Modèles de hasards proportionnels</term>
<term>Mâle</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>Évolution de la maladie</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>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><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>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rathkopf</LastName>
<ForeName>Dana E</ForeName>
<Initials>DE</Initials>
<AffiliationInfo><Affiliation>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: rathkopd@mskcc.org.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Smith</LastName>
<ForeName>Matthew R</ForeName>
<Initials>MR</Initials>
<AffiliationInfo><Affiliation>Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>de Bono</LastName>
<ForeName>Johann S</ForeName>
<Initials>JS</Initials>
<AffiliationInfo><Affiliation>The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Sutton, Surrey, UK.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Logothetis</LastName>
<ForeName>Christopher J</ForeName>
<Initials>CJ</Initials>
<AffiliationInfo><Affiliation>MD Anderson Cancer Center, Houston, TX, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shore</LastName>
<ForeName>Neal D</ForeName>
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