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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Impact of Bone-targeted Therapies in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer Patients Treated with Abiraterone Acetate: Post Hoc Analysis of Study COU-AA-302</title><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation><nlm:aff id="A1">University of Montréal, Montréal, Québec, Canada</nlm:aff></affiliation></author><author><name sortKey="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name><affiliation><nlm:aff id="A2">Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA</nlm:aff></affiliation></author><author><name sortKey="Van Poppel, Hendrik" sort="Van Poppel, Hendrik" uniqKey="Van Poppel H" first="Hendrik" last="Van Poppel">Hendrik Van Poppel</name><affiliation><nlm:aff id="A3">University Hospital Leuven, Leuven, Belgium</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="A4">Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, 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="A5">Harvard Medical School and Massachusetts General Hospital, Boston, MA, 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="A6">The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, UK</nlm:aff></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><nlm:aff id="A7">MD Anderson Cancer Center, Houston, TX, USA</nlm:aff></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><nlm:aff id="A8">University of Western Sydney School of Medicine, Ingham Institute, Liverpool, Australia</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="A9">Institut Gustave Roussy, University of Paris Sud, Villejuif, France</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="A10">Radboud University Medical Centre, Nijmegen, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name><affiliation><nlm:aff id="A11">Hematology and Oncology Clinics of Australia, Brisbane, Australia</nlm:aff></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><nlm:aff id="A12">Sarah Cannon Research Institute, Nashville, TN, USA</nlm:aff></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><nlm:aff id="A13">Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA</nlm:aff></affiliation></author><author><name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name><affiliation><nlm:aff id="A14">Cross Cancer Institute, Edmonton, Alberta, Canada</nlm:aff></affiliation></author><author><name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name><affiliation><nlm:aff id="A15">Laval University, Québec City, Québec, Canada</nlm:aff></affiliation></author><author><name sortKey="Griffin, Thomas A" sort="Griffin, Thomas A" uniqKey="Griffin T" first="Thomas A." last="Griffin">Thomas A. Griffin</name><affiliation><nlm:aff id="A16">Janssen Research & Development, Los Angeles, 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="A17">Janssen Research & Development, Beerse, Belgium</nlm:aff></affiliation></author><author><name sortKey="Londhe, Anil" sort="Londhe, Anil" uniqKey="Londhe A" first="Anil" last="Londhe">Anil Londhe</name><affiliation><nlm:aff id="A18">Janssen Research & Development, LLC, Raritan, NJ, 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="A19">Janssen Research & Development, San Diego, CA, 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="A20">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</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="A4">Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA</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="A21">Janssen Research & Development, Menlo Park, CA, USA</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="A20">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25985882</idno><idno type="pmc">5056561</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5056561</idno><idno type="RBID">PMC:5056561</idno><idno type="doi">10.1016/j.eururo.2015.04.032</idno><date when="2015">2015</date><idno type="wicri:Area/Pmc/Corpus">001F54</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001F54</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Impact of Bone-targeted Therapies in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer Patients Treated with Abiraterone Acetate: Post Hoc Analysis of Study COU-AA-302</title><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation><nlm:aff id="A1">University of Montréal, Montréal, Québec, Canada</nlm:aff></affiliation></author><author><name sortKey="Shore, Neal" sort="Shore, Neal" uniqKey="Shore N" first="Neal" last="Shore">Neal Shore</name><affiliation><nlm:aff id="A2">Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA</nlm:aff></affiliation></author><author><name sortKey="Van Poppel, Hendrik" sort="Van Poppel, Hendrik" uniqKey="Van Poppel H" first="Hendrik" last="Van Poppel">Hendrik Van Poppel</name><affiliation><nlm:aff id="A3">University Hospital Leuven, Leuven, Belgium</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="A4">Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, 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="A5">Harvard Medical School and Massachusetts General Hospital, Boston, MA, 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="A6">The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, UK</nlm:aff></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><nlm:aff id="A7">MD Anderson Cancer Center, Houston, TX, USA</nlm:aff></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><nlm:aff id="A8">University of Western Sydney School of Medicine, Ingham Institute, Liverpool, Australia</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="A9">Institut Gustave Roussy, University of Paris Sud, Villejuif, France</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="A10">Radboud University Medical Centre, Nijmegen, The Netherlands</nlm:aff></affiliation></author><author><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name><affiliation><nlm:aff id="A11">Hematology and Oncology Clinics of Australia, Brisbane, Australia</nlm:aff></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><nlm:aff id="A12">Sarah Cannon Research Institute, Nashville, TN, USA</nlm:aff></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><nlm:aff id="A13">Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA</nlm:aff></affiliation></author><author><name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name><affiliation><nlm:aff id="A14">Cross Cancer Institute, Edmonton, Alberta, Canada</nlm:aff></affiliation></author><author><name sortKey="Fradet, Yves" sort="Fradet, Yves" uniqKey="Fradet Y" first="Yves" last="Fradet">Yves Fradet</name><affiliation><nlm:aff id="A15">Laval University, Québec City, Québec, Canada</nlm:aff></affiliation></author><author><name sortKey="Griffin, Thomas A" sort="Griffin, Thomas A" uniqKey="Griffin T" first="Thomas A." last="Griffin">Thomas A. Griffin</name><affiliation><nlm:aff id="A16">Janssen Research & Development, Los Angeles, 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="A17">Janssen Research & Development, Beerse, Belgium</nlm:aff></affiliation></author><author><name sortKey="Londhe, Anil" sort="Londhe, Anil" uniqKey="Londhe A" first="Anil" last="Londhe">Anil Londhe</name><affiliation><nlm:aff id="A18">Janssen Research & Development, LLC, Raritan, NJ, 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="A19">Janssen Research & Development, San Diego, CA, 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="A20">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</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="A4">Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA</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="A21">Janssen Research & Development, Menlo Park, CA, USA</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="A20">Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</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">Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy.</p></sec><sec id="S2"><title>Objective</title><p id="P2">Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients.</p></sec><sec id="S3"><title>Design, setting, and participants</title><p id="P3">This report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial.</p></sec><sec id="S4"><title>Intervention</title><p id="P4">Patients were grouped by concomitant BTT use or no BTT use.</p></sec><sec id="S5"><title>Outcome measurements and statistical analysis</title><p id="P5">Radiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and <italic>p</italic> values for concomitant BTT versus no BTT were obtained via Cox models.</p></sec><sec id="S6"><title>Results and limitations</title><p id="P6">While the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; <italic>p</italic> = 0.01) and increased the time to ECOG deterioration (HR 0.75; <italic>p</italic> < 0.001) and time to opiate use for cancer-related pain (HR 0.80; <italic>p</italic> = 0.036). The safety profile of concomitant BTT with AA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in <3% of patients.</p></sec><sec id="S7"><title>Conclusions</title><p id="P7">AA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT.</p></sec><sec id="S8"><title>Patient summary</title><p id="P8">Treatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone in combination with bone-targeted therapy, there was a continued trend in prolongation of life when compared with patients treated with prednisone alone.</p></sec><sec id="S9"><title>Trial registration</title><p id="P9"><ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> NCT00887198.</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>
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<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">25985882</article-id><article-id pub-id-type="pmc">5056561</article-id><article-id pub-id-type="doi">10.1016/j.eururo.2015.04.032</article-id><article-id pub-id-type="manuscript">NIHMS810853</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Impact of Bone-targeted Therapies in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer Patients Treated with Abiraterone Acetate: Post Hoc Analysis of Study COU-AA-302</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Saad</surname><given-names>Fred</given-names></name><xref ref-type="aff" rid="A1">a</xref><xref ref-type="corresp" rid="cor1">*</xref></contrib><contrib contrib-type="author"><name><surname>Shore</surname><given-names>Neal</given-names></name><xref ref-type="aff" rid="A2">b</xref></contrib><contrib contrib-type="author"><name><surname>Van Poppel</surname><given-names>Hendrik</given-names></name><xref ref-type="aff" rid="A3">c</xref></contrib><contrib contrib-type="author"><name><surname>Rathkopf</surname><given-names>Dana E.</given-names></name><xref ref-type="aff" rid="A4">d</xref></contrib><contrib contrib-type="author"><name><surname>Smith</surname><given-names>Matthew R.</given-names></name><xref ref-type="aff" rid="A5">e</xref></contrib><contrib contrib-type="author"><name><surname>de Bono</surname><given-names>Johann S.</given-names></name><xref ref-type="aff" rid="A6">f</xref></contrib><contrib contrib-type="author"><name><surname>Logothetis</surname><given-names>Christopher J.</given-names></name><xref ref-type="aff" rid="A7">g</xref></contrib><contrib contrib-type="author"><name><surname>de Souza</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="A8">h</xref></contrib><contrib contrib-type="author"><name><surname>Fizazi</surname><given-names>Karim</given-names></name><xref ref-type="aff" rid="A9">i</xref></contrib><contrib contrib-type="author"><name><surname>Mulders</surname><given-names>Peter F.A.</given-names></name><xref ref-type="aff" rid="A10">j</xref></contrib><contrib contrib-type="author"><name><surname>Mainwaring</surname><given-names>Paul</given-names></name><xref ref-type="aff" rid="A11">k</xref></contrib><contrib contrib-type="author"><name><surname>Hainsworth</surname><given-names>John D.</given-names></name><xref ref-type="aff" rid="A12">l</xref></contrib><contrib contrib-type="author"><name><surname>Beer</surname><given-names>Tomasz M.</given-names></name><xref ref-type="aff" rid="A13">m</xref></contrib><contrib contrib-type="author"><name><surname>North</surname><given-names>Scott</given-names></name><xref ref-type="aff" rid="A14">n</xref></contrib><contrib contrib-type="author"><name><surname>Fradet</surname><given-names>Yves</given-names></name><xref ref-type="aff" rid="A15">o</xref></contrib><contrib contrib-type="author"><name><surname>Griffin</surname><given-names>Thomas A.</given-names></name><xref ref-type="aff" rid="A16">p</xref></contrib><contrib contrib-type="author"><name><surname>De Porre</surname><given-names>Peter</given-names></name><xref ref-type="aff" rid="A17">q</xref></contrib><contrib contrib-type="author"><name><surname>Londhe</surname><given-names>Anil</given-names></name><xref ref-type="aff" rid="A18">r</xref></contrib><contrib contrib-type="author"><name><surname>Kheoh</surname><given-names>Thian</given-names></name><xref ref-type="aff" rid="A19">s</xref></contrib><contrib contrib-type="author"><name><surname>Small</surname><given-names>Eric J.</given-names></name><xref ref-type="aff" rid="A20">t</xref></contrib><contrib contrib-type="author"><name><surname>Scher</surname><given-names>Howard I.</given-names></name><xref ref-type="aff" rid="A4">d</xref></contrib><contrib contrib-type="author"><name><surname>Molina</surname><given-names>Arturo</given-names></name><xref ref-type="aff" rid="A21">u</xref></contrib><contrib contrib-type="author"><name><surname>Ryan</surname><given-names>Charles J.</given-names></name><xref ref-type="aff" rid="A20">t</xref></contrib></contrib-group><aff id="A1"><label>a</label>University of Montréal, Montréal, Québec, Canada</aff><aff id="A2"><label>b</label>Carolina Urologic Research Center, Atlantic Urology Clinics, Myrtle Beach, SC, USA</aff><aff id="A3"><label>c</label>University Hospital Leuven, Leuven, Belgium</aff><aff id="A4"><label>d</label>Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA</aff><aff id="A5"><label>e</label>Harvard Medical School and Massachusetts General Hospital, Boston, MA, USA</aff><aff id="A6"><label>f</label>The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, UK</aff><aff id="A7"><label>g</label>MD Anderson Cancer Center, Houston, TX, USA</aff><aff id="A8"><label>h</label>University of Western Sydney School of Medicine, Ingham Institute, Liverpool, Australia</aff><aff id="A9"><label>i</label>Institut Gustave Roussy, University of Paris Sud, Villejuif, France</aff><aff id="A10"><label>j</label>Radboud University Medical Centre, Nijmegen, The Netherlands</aff><aff id="A11"><label>k</label>Hematology and Oncology Clinics of Australia, Brisbane, Australia</aff><aff id="A12"><label>l</label>Sarah Cannon Research Institute, Nashville, TN, USA</aff><aff id="A13"><label>m</label>Oregon Health & Science University Knight Cancer Institute, Portland, OR, USA</aff><aff id="A14"><label>n</label>Cross Cancer Institute, Edmonton, Alberta, Canada</aff><aff id="A15"><label>o</label>Laval University, Québec City, Québec, Canada</aff><aff id="A16"><label>p</label>Janssen Research & Development, Los Angeles, CA, USA</aff><aff id="A17"><label>q</label>Janssen Research & Development, Beerse, Belgium</aff><aff id="A18"><label>r</label>Janssen Research & Development, LLC, Raritan, NJ, USA</aff><aff id="A19"><label>s</label>Janssen Research & Development, San Diego, CA, USA</aff><aff id="A20"><label>t</label>Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA</aff><aff id="A21"><label>u</label>Janssen Research & Development, Menlo Park, CA, USA</aff><author-notes><corresp id="cor1"><label>*</label>Corresponding author. University of Montreal Health Center,560 Rue Sherbrooke E, Montreal, Quebec H2L 4M1, Canada. Tel. +1 514 8908000 ext 27466; Fax: +1 514 4127620. <email>fredsaad@videotron.ca</email> (F. Saad)</corresp></author-notes><pub-date pub-type="nihms-submitted"><day>23</day><month>9</month><year>2016</year></pub-date><pub-date pub-type="epub"><day>16</day><month>5</month><year>2015</year></pub-date><pub-date pub-type="ppub"><month>10</month><year>2015</year></pub-date><pub-date pub-type="pmc-release"><day>10</day><month>10</month><year>2016</year></pub-date><volume>68</volume><issue>4</issue><fpage>570</fpage><lpage>577</lpage><pmc-comment>elocation-id from pubmed: 10.1016/j.eururo.2015.04.032</pmc-comment>
<abstract><sec id="S1"><title>Background</title><p id="P1">Metastatic castration-resistant prostate cancer (mCRPC) often involves bone, and bone-targeted therapy (BTT) has become part of the overall treatment strategy.</p></sec><sec id="S2"><title>Objective</title><p id="P2">Investigation of outcomes for concomitant BTT in a post hoc analysis of the COU-AA-302 trial, which demonstrated an overall clinical benefit of abiraterone acetate (AA) plus prednisone over placebo plus prednisone in asymptomatic or mildly symptomatic chemotherapy-naïve mCRPC patients.</p></sec><sec id="S3"><title>Design, setting, and participants</title><p id="P3">This report describes the third interim analysis (prespecified at 55% overall survival [OS] events) for the COU-AA-302 trial.</p></sec><sec id="S4"><title>Intervention</title><p id="P4">Patients were grouped by concomitant BTT use or no BTT use.</p></sec><sec id="S5"><title>Outcome measurements and statistical analysis</title><p id="P5">Radiographic progression-free survival and OS were coprimary end points. This report describes the third interim analysis (prespecified at 55% OS events) and involves patients treated with or without concomitant BTT during the COU-AA-302 study. Median follow-up for OS was 27.1 mo. Median time-to-event variables with 95% confidence intervals (CIs) were estimated using the Kaplan-Meier method. Adjusted hazard ratios (HRs), 95% CIs, and <italic>p</italic> values for concomitant BTT versus no BTT were obtained via Cox models.</p></sec><sec id="S6"><title>Results and limitations</title><p id="P6">While the post hoc nature of the analysis is a limitation, superiority of AA and prednisone versus prednisone alone was demonstrated for clinical outcomes with or without BTT use. Compared with no BTT use, concomitant BTT significantly improved OS (HR 0.75; <italic>p</italic> = 0.01) and increased the time to ECOG deterioration (HR 0.75; <italic>p</italic> < 0.001) and time to opiate use for cancer-related pain (HR 0.80; <italic>p</italic> = 0.036). The safety profile of concomitant BTT with AA was similar to that reported for AA in the overall intent-to-treat population. Osteonecrosis of the jaw (all grade 1/2) with concomitant BTT use was reported in <3% of patients.</p></sec><sec id="S7"><title>Conclusions</title><p id="P7">AA with concomitant BTT was safe and well tolerated in men with chemotherapy-naïve mCRPC. The benefits of AA on clinical outcomes were increased with concomitant BTT.</p></sec><sec id="S8"><title>Patient summary</title><p id="P8">Treatment of advanced prostate cancer often includes bone-targeted therapy. This post hoc analysis showed that in patients with advanced prostate cancer who were treated with abiraterone acetate and prednisone in combination with bone-targeted therapy, there was a continued trend in prolongation of life when compared with patients treated with prednisone alone.</p></sec><sec id="S9"><title>Trial registration</title><p id="P9"><ext-link ext-link-type="uri" xlink:href="http://ClinicalTrials.gov">ClinicalTrials.gov</ext-link> NCT00887198.</p></sec></abstract><kwd-group><kwd>Abiraterone acetate</kwd><kwd>Bone-targeted therapy</kwd><kwd>Chemotherapy-naïve</kwd><kwd>Metastatic castration-resistant prostate cancer</kwd></kwd-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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