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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies</title><author><name sortKey="Bellmunt, Joaquim" sort="Bellmunt, Joaquim" uniqKey="Bellmunt J" first="Joaquim" last="Bellmunt">Joaquim Bellmunt</name><affiliation><nlm:aff id="A1">Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name><affiliation><nlm:aff id="A2">Janssen Research and Development, San Diego, CA, USA</nlm:aff></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><nlm:aff id="A3">Janssen Research and Development, Los Angeles, CA, USA</nlm:aff></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><nlm:aff id="A4">Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA</nlm:aff></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><nlm:aff id="A5">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</nlm:aff></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><nlm:aff id="A6">Radboud University Medical Centre, Nijmegen, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name><affiliation><nlm:aff id="A7">Institut Gustave Roussy, University of Paris Sud, Villejuif, France</nlm:aff></affiliation></author><author><name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E." last="Rathkopf">Dana E. Rathkopf</name><affiliation><nlm:aff id="A8">Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation><nlm:aff id="A9">University of Montréal, Montréal, Québec, Canada</nlm:aff></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><nlm:aff id="A8">Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA</nlm:aff></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><nlm:aff id="A1">Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Davis, Ian D" sort="Davis, Ian D" uniqKey="Davis I" first="Ian D." last="Davis">Ian D. Davis</name><affiliation><nlm:aff id="A10">Monash University and Eastern Health, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Schrijvers, Dirk" sort="Schrijvers, Dirk" uniqKey="Schrijvers D" first="Dirk" last="Schrijvers">Dirk Schrijvers</name><affiliation><nlm:aff id="A11">ZNA Middelheim Oncology Clinic, Medical Oncology, Antwerp, Belgium</nlm:aff></affiliation></author><author><name sortKey="Protheroe, Andrew" sort="Protheroe, Andrew" uniqKey="Protheroe A" first="Andrew" last="Protheroe">Andrew Protheroe</name><affiliation><nlm:aff id="A12">Churchill Hospital, Oxford, UK</nlm:aff></affiliation></author><author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name><affiliation><nlm:aff id="A13">Janssen Research & Development, Menlo Park, CA, USA</nlm:aff></affiliation></author><author><name sortKey="De Porre, Peter" sort="De Porre, Peter" uniqKey="De Porre P" first="Peter" last="De Porre">Peter De Porre</name><affiliation><nlm:aff id="A14">Janssen Research & Development, Beerse, Belgium</nlm:aff></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><nlm:aff id="A3">Janssen Research and Development, Los Angeles, CA, USA</nlm:aff></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><nlm:aff id="A15">The Institute of Cancer Research and The Royal Marsden Hospital, Sutton, UK</nlm:aff></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><nlm:aff id="A5">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stéphane" last="Oudard">Stéphane Oudard</name><affiliation><nlm:aff id="A16">Georges Pompidou Hospital, University René Descartes, Paris, France</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">26508309</idno><idno type="pmc">5465643</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5465643</idno><idno type="RBID">PMC:5465643</idno><idno type="doi">10.1016/j.eururo.2015.10.021</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">001F55</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001F55</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies</title><author><name sortKey="Bellmunt, Joaquim" sort="Bellmunt, Joaquim" uniqKey="Bellmunt J" first="Joaquim" last="Bellmunt">Joaquim Bellmunt</name><affiliation><nlm:aff id="A1">Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name><affiliation><nlm:aff id="A2">Janssen Research and Development, San Diego, CA, USA</nlm:aff></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><nlm:aff id="A3">Janssen Research and Development, Los Angeles, CA, USA</nlm:aff></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><nlm:aff id="A4">Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA</nlm:aff></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><nlm:aff id="A5">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</nlm:aff></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><nlm:aff id="A6">Radboud University Medical Centre, Nijmegen, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name><affiliation><nlm:aff id="A7">Institut Gustave Roussy, University of Paris Sud, Villejuif, France</nlm:aff></affiliation></author><author><name sortKey="Rathkopf, Dana E" sort="Rathkopf, Dana E" uniqKey="Rathkopf D" first="Dana E." last="Rathkopf">Dana E. Rathkopf</name><affiliation><nlm:aff id="A8">Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA</nlm:aff></affiliation></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation><nlm:aff id="A9">University of Montréal, Montréal, Québec, Canada</nlm:aff></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><nlm:aff id="A8">Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA</nlm:aff></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><nlm:aff id="A1">Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA</nlm:aff></affiliation></author><author><name sortKey="Davis, Ian D" sort="Davis, Ian D" uniqKey="Davis I" first="Ian D." last="Davis">Ian D. Davis</name><affiliation><nlm:aff id="A10">Monash University and Eastern Health, Victoria, Australia</nlm:aff></affiliation></author><author><name sortKey="Schrijvers, Dirk" sort="Schrijvers, Dirk" uniqKey="Schrijvers D" first="Dirk" last="Schrijvers">Dirk Schrijvers</name><affiliation><nlm:aff id="A11">ZNA Middelheim Oncology Clinic, Medical Oncology, Antwerp, Belgium</nlm:aff></affiliation></author><author><name sortKey="Protheroe, Andrew" sort="Protheroe, Andrew" uniqKey="Protheroe A" first="Andrew" last="Protheroe">Andrew Protheroe</name><affiliation><nlm:aff id="A12">Churchill Hospital, Oxford, UK</nlm:aff></affiliation></author><author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name><affiliation><nlm:aff id="A13">Janssen Research & Development, Menlo Park, CA, USA</nlm:aff></affiliation></author><author><name sortKey="De Porre, Peter" sort="De Porre, Peter" uniqKey="De Porre P" first="Peter" last="De Porre">Peter De Porre</name><affiliation><nlm:aff id="A14">Janssen Research & Development, Beerse, Belgium</nlm:aff></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><nlm:aff id="A3">Janssen Research and Development, Los Angeles, CA, USA</nlm:aff></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><nlm:aff id="A15">The Institute of Cancer Research and The Royal Marsden Hospital, Sutton, UK</nlm:aff></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><nlm:aff id="A5">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</nlm:aff></affiliation></author><author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stéphane" last="Oudard">Stéphane Oudard</name><affiliation><nlm:aff id="A16">Georges Pompidou Hospital, University René Descartes, Paris, France</nlm:aff></affiliation></author></analytic><series><title level="j">European urology</title><idno type="ISSN">0302-2838</idno><idno type="eISSN">1873-7560</idno><imprint><date when="2015">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec id="S1"><title>Background</title><p id="P1">The duration of prior hormonal treatment can predict responses to subsequent therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).</p></sec><sec id="S2"><title>Objective</title><p id="P2">To determine if prior endocrine therapy duration is an indicator of abiraterone acetate (AA) sensitivity.</p></sec><sec id="S3"><title>Design, setting, and participants</title><p id="P3">Post-hoc exploratory analysis of randomised phase 3 studies examining post-docetaxel (COU-AA-301) or chemotherapy-naïve mCRPC (COU-AA-302) patients receiving AA. The treatment effect on overall survival (OS), radiographic progression-free survival (rPFS), and prostate-specific antigen (PSA) response analysed by quartile duration of prior gonadotropin-releasing hormone agonists (GnRHa) or androgen receptor (AR) antagonist.</p></sec><sec id="S4"><title>Intervention</title><p id="P4">Patients were randomised to AA (1000 mg, orally once daily) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone. Prior endocrine therapy was GnRHa (COU-AA-301, <italic>n</italic> = 1127 [94%]; COU-AA-302, <italic>n</italic> = 1057 [97%], 45.1 mo or 36.7 mo median duration, respectively) and/or orchiectomy (COU-AA-301, <italic>n</italic> = 78 [7%] COU-AA-302, <italic>n</italic> = 44 [4%]); castrated patients received prior AR antagonists (COU-AA-301, <italic>n</italic> = 1015 [85%]; COU-AA-302, <italic>n</italic> = 1078 [99%], 15.7 mo or 16.1 mo median duration, respectively).</p></sec><sec id="S5"><title>Outcome measurements and statistical analysis</title><p id="P5">Cox model was used to obtain hazard ratio and associated 95% confidence interval with statistical inference by log rank statistic.</p></sec><sec id="S6"><title>Results and limitations</title><p id="P6">Clinical benefit with AA was observed for OS, rPFS, and PSA response for nearly all quartiles with GnRHa or AR antagonists in both COU-AA-301 and COU-AA-302. In COU-AA-301, patients with a longer duration of prior endocrine therapy tended to have greater AA OS, rPFS, and PSA response benefit, with lead-time chemotherapy bias potentially impacting COU-AA-301 results. Time-to-castration-resistance was not captured. This analysis is limited as a post-hoc exploratory analysis.</p></sec><sec id="S7"><title>Conclusions</title><p id="P7">In the COU-AA-301 and COU-AA-302 studies, AA produced clinical benefits regardless of prior endocrine therapy duration in patients with mCRPC.</p></sec><sec id="S8"><title>Patient summary</title><p id="P8">Metastatic castration-resistant prostate cancer patients derived clinical benefits with abiraterone acetate regardless of prior endocrine therapy duration.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">7512719</journal-id><journal-id journal-id-type="pubmed-jr-id">3630</journal-id><journal-id journal-id-type="nlm-ta">Eur Urol</journal-id><journal-id journal-id-type="iso-abbrev">Eur. Urol.</journal-id><journal-title-group><journal-title>European urology</journal-title></journal-title-group><issn pub-type="ppub">0302-2838</issn><issn pub-type="epub">1873-7560</issn></journal-meta><article-meta><article-id pub-id-type="pmid">26508309</article-id><article-id pub-id-type="pmc">5465643</article-id><article-id pub-id-type="doi">10.1016/j.eururo.2015.10.021</article-id><article-id pub-id-type="manuscript">NIHMS866511</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Bellmunt</surname><given-names>Joaquim</given-names></name><xref ref-type="aff" rid="A1">a</xref><xref rid="FN1" ref-type="author-notes">*</xref></contrib><contrib contrib-type="author"><name><surname>Kheoh</surname><given-names>Thian</given-names></name><xref ref-type="aff" rid="A2">b</xref></contrib><contrib contrib-type="author"><name><surname>Yu</surname><given-names>Margaret K.</given-names></name><xref ref-type="aff" rid="A3">c</xref></contrib><contrib contrib-type="author"><name><surname>Smith</surname><given-names>Matthew R.</given-names></name><xref ref-type="aff" rid="A4">d</xref></contrib><contrib contrib-type="author"><name><surname>Small</surname><given-names>Eric J.</given-names></name><xref ref-type="aff" rid="A5">e</xref></contrib><contrib contrib-type="author"><name><surname>Mulders</surname><given-names>Peter F.A.</given-names></name><xref ref-type="aff" rid="A6">f</xref></contrib><contrib contrib-type="author"><name><surname>Fizazi</surname><given-names>Karim</given-names></name><xref ref-type="aff" rid="A7">g</xref></contrib><contrib contrib-type="author"><name><surname>Rathkopf</surname><given-names>Dana E.</given-names></name><xref ref-type="aff" rid="A8">h</xref></contrib><contrib contrib-type="author"><name><surname>Saad</surname><given-names>Fred</given-names></name><xref ref-type="aff" rid="A9">i</xref></contrib><contrib contrib-type="author"><name><surname>Scher</surname><given-names>Howard I.</given-names></name><xref ref-type="aff" rid="A8">h</xref></contrib><contrib contrib-type="author"><name><surname>Taplin</surname><given-names>Mary-Ellen</given-names></name><xref ref-type="aff" rid="A1">a</xref></contrib><contrib contrib-type="author"><name><surname>Davis</surname><given-names>Ian D.</given-names></name><xref ref-type="aff" rid="A10">j</xref></contrib><contrib contrib-type="author"><name><surname>Schrijvers</surname><given-names>Dirk</given-names></name><xref ref-type="aff" rid="A11">k</xref></contrib><contrib contrib-type="author"><name><surname>Protheroe</surname><given-names>Andrew</given-names></name><xref ref-type="aff" rid="A12">l</xref></contrib><contrib contrib-type="author"><name><surname>Molina</surname><given-names>Arturo</given-names></name><xref ref-type="aff" rid="A13">m</xref></contrib><contrib contrib-type="author"><name><surname>De Porre</surname><given-names>Peter</given-names></name><xref ref-type="aff" rid="A14">n</xref></contrib><contrib contrib-type="author"><name><surname>Griffin</surname><given-names>Thomas W.</given-names></name><xref ref-type="aff" rid="A3">c</xref></contrib><contrib contrib-type="author"><name><surname>de Bono</surname><given-names>Johann S.</given-names></name><xref ref-type="aff" rid="A15">o</xref></contrib><contrib contrib-type="author"><name><surname>Ryan</surname><given-names>Charles J.</given-names></name><xref ref-type="aff" rid="A5">e</xref></contrib><contrib contrib-type="author"><name><surname>Oudard</surname><given-names>Stéphane</given-names></name><xref ref-type="aff" rid="A16">p</xref></contrib></contrib-group><aff id="A1"><label>a</label>Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA</aff><aff id="A2"><label>b</label>Janssen Research and Development, San Diego, CA, USA</aff><aff id="A3"><label>c</label>Janssen Research and Development, Los Angeles, CA, USA</aff><aff id="A4"><label>d</label>Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA</aff><aff id="A5"><label>e</label>Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</aff><aff id="A6"><label>f</label>Radboud University Medical Centre, Nijmegen, The Netherlands</aff><aff id="A7"><label>g</label>Institut Gustave Roussy, University of Paris Sud, Villejuif, France</aff><aff id="A8"><label>h</label>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA</aff><aff id="A9"><label>i</label>University of Montréal, Montréal, Québec, Canada</aff><aff id="A10"><label>j</label>Monash University and Eastern Health, Victoria, Australia</aff><aff id="A11"><label>k</label>ZNA Middelheim Oncology Clinic, Medical Oncology, Antwerp, Belgium</aff><aff id="A12"><label>l</label>Churchill Hospital, Oxford, UK</aff><aff id="A13"><label>m</label>Janssen Research & Development, Menlo Park, CA, USA</aff><aff id="A14"><label>n</label>Janssen Research & Development, Beerse, Belgium</aff><aff id="A15"><label>o</label>The Institute of Cancer Research and The Royal Marsden Hospital, Sutton, UK</aff><aff id="A16"><label>p</label>Georges Pompidou Hospital, University René Descartes, Paris, France</aff><author-notes><corresp id="FN1"><label>*</label>Corresponding author. Harvard Medical School, Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, 450 Brookline Avenue, Boston, MA 02215-5450, USA. Tel. +1 617 632 3237; Fax: +1 617 632 2165.; <email>Joaquim_Bellmunt@dfci.harvard.edu</email> (J. Bellmunt)</corresp></author-notes><pub-date pub-type="nihms-submitted"><day>8</day><month>4</month><year>2017</year></pub-date><pub-date pub-type="epub"><day>24</day><month>10</month><year>2015</year></pub-date><pub-date pub-type="ppub"><month>5</month><year>2016</year></pub-date><pub-date pub-type="pmc-release"><day>09</day><month>6</month><year>2017</year></pub-date><volume>69</volume><issue>5</issue><fpage>924</fpage><lpage>932</lpage><pmc-comment>elocation-id from pubmed: 10.1016/j.eururo.2015.10.021</pmc-comment>
<abstract><sec id="S1"><title>Background</title><p id="P1">The duration of prior hormonal treatment can predict responses to subsequent therapy in patients with metastatic castration-resistant prostate cancer (mCRPC).</p></sec><sec id="S2"><title>Objective</title><p id="P2">To determine if prior endocrine therapy duration is an indicator of abiraterone acetate (AA) sensitivity.</p></sec><sec id="S3"><title>Design, setting, and participants</title><p id="P3">Post-hoc exploratory analysis of randomised phase 3 studies examining post-docetaxel (COU-AA-301) or chemotherapy-naïve mCRPC (COU-AA-302) patients receiving AA. The treatment effect on overall survival (OS), radiographic progression-free survival (rPFS), and prostate-specific antigen (PSA) response analysed by quartile duration of prior gonadotropin-releasing hormone agonists (GnRHa) or androgen receptor (AR) antagonist.</p></sec><sec id="S4"><title>Intervention</title><p id="P4">Patients were randomised to AA (1000 mg, orally once daily) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone. Prior endocrine therapy was GnRHa (COU-AA-301, <italic>n</italic> = 1127 [94%]; COU-AA-302, <italic>n</italic> = 1057 [97%], 45.1 mo or 36.7 mo median duration, respectively) and/or orchiectomy (COU-AA-301, <italic>n</italic> = 78 [7%] COU-AA-302, <italic>n</italic> = 44 [4%]); castrated patients received prior AR antagonists (COU-AA-301, <italic>n</italic> = 1015 [85%]; COU-AA-302, <italic>n</italic> = 1078 [99%], 15.7 mo or 16.1 mo median duration, respectively).</p></sec><sec id="S5"><title>Outcome measurements and statistical analysis</title><p id="P5">Cox model was used to obtain hazard ratio and associated 95% confidence interval with statistical inference by log rank statistic.</p></sec><sec id="S6"><title>Results and limitations</title><p id="P6">Clinical benefit with AA was observed for OS, rPFS, and PSA response for nearly all quartiles with GnRHa or AR antagonists in both COU-AA-301 and COU-AA-302. In COU-AA-301, patients with a longer duration of prior endocrine therapy tended to have greater AA OS, rPFS, and PSA response benefit, with lead-time chemotherapy bias potentially impacting COU-AA-301 results. Time-to-castration-resistance was not captured. This analysis is limited as a post-hoc exploratory analysis.</p></sec><sec id="S7"><title>Conclusions</title><p id="P7">In the COU-AA-301 and COU-AA-302 studies, AA produced clinical benefits regardless of prior endocrine therapy duration in patients with mCRPC.</p></sec><sec id="S8"><title>Patient summary</title><p id="P8">Metastatic castration-resistant prostate cancer patients derived clinical benefits with abiraterone acetate regardless of prior endocrine therapy duration.</p></sec></abstract><kwd-group><kwd>Abiraterone acetate</kwd><kwd>Androgen receptor antagonists</kwd><kwd>Gonadotropin-releasing hormone</kwd><kwd>Prednisone</kwd><kwd>Prostate cancer</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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