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<title xml:lang="en">Abiraterone and Increased Survival in Metastatic Prostate Cancer</title>
<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>
</author>
<author>
<name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name>
</author>
<author>
<name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
</author>
<author>
<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
</author>
<author>
<name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
</author>
<author>
<name sortKey="Chu, Luis" sort="Chu, Luis" uniqKey="Chu L" first="Luis" last="Chu">Luis Chu</name>
</author>
<author>
<name sortKey="Chi, Kim N" sort="Chi, Kim N" uniqKey="Chi K" first="Kim N." last="Chi">Kim N. Chi</name>
</author>
<author>
<name sortKey="Jones, Robert J" sort="Jones, Robert J" uniqKey="Jones R" first="Robert J." last="Jones">Robert J. Jones</name>
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<author>
<name sortKey="Goodman, Oscar B" sort="Goodman, Oscar B" uniqKey="Goodman O" first="Oscar B." last="Goodman">Oscar B. Goodman</name>
</author>
<author>
<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
</author>
<author>
<name sortKey="Staffurth, John N" sort="Staffurth, John N" uniqKey="Staffurth J" first="John N." last="Staffurth">John N. Staffurth</name>
</author>
<author>
<name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
</author>
<author>
<name sortKey="Harland, Stephen" sort="Harland, Stephen" uniqKey="Harland S" first="Stephen" last="Harland">Stephen Harland</name>
</author>
<author>
<name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name>
</author>
<author>
<name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name>
</author>
<author>
<name sortKey="Cheng, Tina" sort="Cheng, Tina" uniqKey="Cheng T" first="Tina" last="Cheng">Tina Cheng</name>
</author>
<author>
<name sortKey="Patterson, Helen" sort="Patterson, Helen" uniqKey="Patterson H" first="Helen" last="Patterson">Helen Patterson</name>
</author>
<author>
<name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D." last="Hainsworth">John D. Hainsworth</name>
</author>
<author>
<name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J." last="Ryan">Charles J. Ryan</name>
</author>
<author>
<name sortKey="Sternberg, Cora N" sort="Sternberg, Cora N" uniqKey="Sternberg C" first="Cora N." last="Sternberg">Cora N. Sternberg</name>
</author>
<author>
<name sortKey="Ellard, Susan L" sort="Ellard, Susan L" uniqKey="Ellard S" first="Susan L." last="Ellard">Susan L. Ellard</name>
</author>
<author>
<name sortKey="Flehon, Aude" sort="Flehon, Aude" uniqKey="Flehon A" first="Aude" last="Fléhon">Aude Fléhon</name>
</author>
<author>
<name sortKey="Saleh, Mansoor" sort="Saleh, Mansoor" uniqKey="Saleh M" first="Mansoor" last="Saleh">Mansoor Saleh</name>
</author>
<author>
<name sortKey="Scholz, Mark" sort="Scholz, Mark" uniqKey="Scholz M" first="Mark" last="Scholz">Mark Scholz</name>
</author>
<author>
<name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
</author>
<author>
<name sortKey="Zivi, Andrea" sort="Zivi, Andrea" uniqKey="Zivi A" first="Andrea" last="Zivi">Andrea Zivi</name>
</author>
<author>
<name sortKey="Bianchini, Diletta" sort="Bianchini, Diletta" uniqKey="Bianchini D" first="Diletta" last="Bianchini">Diletta Bianchini</name>
</author>
<author>
<name sortKey="Loriot, Yohann" sort="Loriot, Yohann" uniqKey="Loriot Y" first="Yohann" last="Loriot">Yohann Loriot</name>
</author>
<author>
<name sortKey="Chieffo, Nicole" sort="Chieffo, Nicole" uniqKey="Chieffo N" first="Nicole" last="Chieffo">Nicole Chieffo</name>
</author>
<author>
<name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
</author>
<author>
<name sortKey="Haqq, Christopher M" sort="Haqq, Christopher M" uniqKey="Haqq C" first="Christopher M." last="Haqq">Christopher M. Haqq</name>
</author>
<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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<idno type="wicri:source">PMC</idno>
<idno type="pmid">21612468</idno>
<idno type="pmc">3471149</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3471149</idno>
<idno type="RBID">PMC:3471149</idno>
<idno type="doi">10.1056/NEJMoa1014618</idno>
<date when="2011">2011</date>
<idno type="wicri:Area/Pmc/Corpus">001C78</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001C78</idno>
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<biblStruct>
<analytic>
<title xml:lang="en" level="a" type="main">Abiraterone and Increased Survival in Metastatic Prostate Cancer</title>
<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>
</author>
<author>
<name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name>
</author>
<author>
<name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
</author>
<author>
<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
</author>
<author>
<name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
</author>
<author>
<name sortKey="Chu, Luis" sort="Chu, Luis" uniqKey="Chu L" first="Luis" last="Chu">Luis Chu</name>
</author>
<author>
<name sortKey="Chi, Kim N" sort="Chi, Kim N" uniqKey="Chi K" first="Kim N." last="Chi">Kim N. Chi</name>
</author>
<author>
<name sortKey="Jones, Robert J" sort="Jones, Robert J" uniqKey="Jones R" first="Robert J." last="Jones">Robert J. Jones</name>
</author>
<author>
<name sortKey="Goodman, Oscar B" sort="Goodman, Oscar B" uniqKey="Goodman O" first="Oscar B." last="Goodman">Oscar B. Goodman</name>
</author>
<author>
<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
</author>
<author>
<name sortKey="Staffurth, John N" sort="Staffurth, John N" uniqKey="Staffurth J" first="John N." last="Staffurth">John N. Staffurth</name>
</author>
<author>
<name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
</author>
<author>
<name sortKey="Harland, Stephen" sort="Harland, Stephen" uniqKey="Harland S" first="Stephen" last="Harland">Stephen Harland</name>
</author>
<author>
<name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name>
</author>
<author>
<name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name>
</author>
<author>
<name sortKey="Cheng, Tina" sort="Cheng, Tina" uniqKey="Cheng T" first="Tina" last="Cheng">Tina Cheng</name>
</author>
<author>
<name sortKey="Patterson, Helen" sort="Patterson, Helen" uniqKey="Patterson H" first="Helen" last="Patterson">Helen Patterson</name>
</author>
<author>
<name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D." last="Hainsworth">John D. Hainsworth</name>
</author>
<author>
<name sortKey="Ryan, Charles J" sort="Ryan, Charles J" uniqKey="Ryan C" first="Charles J." last="Ryan">Charles J. Ryan</name>
</author>
<author>
<name sortKey="Sternberg, Cora N" sort="Sternberg, Cora N" uniqKey="Sternberg C" first="Cora N." last="Sternberg">Cora N. Sternberg</name>
</author>
<author>
<name sortKey="Ellard, Susan L" sort="Ellard, Susan L" uniqKey="Ellard S" first="Susan L." last="Ellard">Susan L. Ellard</name>
</author>
<author>
<name sortKey="Flehon, Aude" sort="Flehon, Aude" uniqKey="Flehon A" first="Aude" last="Fléhon">Aude Fléhon</name>
</author>
<author>
<name sortKey="Saleh, Mansoor" sort="Saleh, Mansoor" uniqKey="Saleh M" first="Mansoor" last="Saleh">Mansoor Saleh</name>
</author>
<author>
<name sortKey="Scholz, Mark" sort="Scholz, Mark" uniqKey="Scholz M" first="Mark" last="Scholz">Mark Scholz</name>
</author>
<author>
<name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
</author>
<author>
<name sortKey="Zivi, Andrea" sort="Zivi, Andrea" uniqKey="Zivi A" first="Andrea" last="Zivi">Andrea Zivi</name>
</author>
<author>
<name sortKey="Bianchini, Diletta" sort="Bianchini, Diletta" uniqKey="Bianchini D" first="Diletta" last="Bianchini">Diletta Bianchini</name>
</author>
<author>
<name sortKey="Loriot, Yohann" sort="Loriot, Yohann" uniqKey="Loriot Y" first="Yohann" last="Loriot">Yohann Loriot</name>
</author>
<author>
<name sortKey="Chieffo, Nicole" sort="Chieffo, Nicole" uniqKey="Chieffo N" first="Nicole" last="Chieffo">Nicole Chieffo</name>
</author>
<author>
<name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
</author>
<author>
<name sortKey="Haqq, Christopher M" sort="Haqq, Christopher M" uniqKey="Haqq C" first="Christopher M." last="Haqq">Christopher M. Haqq</name>
</author>
<author>
<name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name>
</author>
</analytic>
<series>
<title level="j">The New England journal of medicine</title>
<idno type="ISSN">0028-4793</idno>
<idno type="eISSN">1533-4406</idno>
<imprint>
<date when="2011">2011</date>
</imprint>
</series>
</biblStruct>
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</teiHeader>
<front>
<div type="abstract" xml:lang="en">
<sec id="S1">
<title>BACKGROUND</title>
<p id="P1">Biosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy.</p>
</sec>
<sec id="S2">
<title>METHODS</title>
<p id="P2">We randomly assigned, in a 2:1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate.</p>
</sec>
<sec id="S3">
<title>RESULTS</title>
<p id="P3">After a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate–prednisone group than in the placebo–prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001). Data were unblinded at the interim analysis, since these results exceeded the preplanned criteria for study termination. All secondary end points, including time to PSA progression (10.2 vs. 6.6 months; P<0.001), progression-free survival (5.6 months vs. 3.6 months; P<0.001), and PSA response rate (29% vs. 6%, P<0.001), favored the treatment group. Mineralocorticoid-related adverse events, including fluid retention, hypertension, and hypokalemia, were more frequently reported in the abiraterone acetate–prednisone group than in the placebo–prednisone group.</p>
</sec>
<sec id="S4">
<title>CONCLUSIONS</title>
<p id="P4">The inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy. (Funded by Cougar Biotechnology; COU-AA-301 ClinicalTrials.gov number, NCT00638690.)</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">0255562</journal-id>
<journal-id journal-id-type="pubmed-jr-id">5985</journal-id>
<journal-id journal-id-type="nlm-ta">N Engl J Med</journal-id>
<journal-id journal-id-type="iso-abbrev">N. Engl. J. Med.</journal-id>
<journal-title-group>
<journal-title>The New England journal of medicine</journal-title>
</journal-title-group>
<issn pub-type="ppub">0028-4793</issn>
<issn pub-type="epub">1533-4406</issn>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">21612468</article-id>
<article-id pub-id-type="pmc">3471149</article-id>
<article-id pub-id-type="doi">10.1056/NEJMoa1014618</article-id>
<article-id pub-id-type="manuscript">NIHMS385224</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Article</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Abiraterone and Increased Survival in Metastatic Prostate Cancer</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>de Bono</surname>
<given-names>Johann S.</given-names>
</name>
<degrees>M.B., Ch.B., Ph.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Logothetis</surname>
<given-names>Christopher J.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Molina</surname>
<given-names>Arturo</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Fizazi</surname>
<given-names>Karim</given-names>
</name>
<degrees>M.D., Ph.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>North</surname>
<given-names>Scott</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Chu</surname>
<given-names>Luis</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Chi</surname>
<given-names>Kim N.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Jones</surname>
<given-names>Robert J.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Goodman</surname>
<given-names>Oscar B.</given-names>
<suffix>Jr.</suffix>
</name>
<degrees>M.D., Ph.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Saad</surname>
<given-names>Fred</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Staffurth</surname>
<given-names>John N.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Mainwaring</surname>
<given-names>Paul</given-names>
</name>
<degrees>M.D., M.B., B.S.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Harland</surname>
<given-names>Stephen</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Flaig</surname>
<given-names>Thomas W.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Hutson</surname>
<given-names>Thomas E.</given-names>
</name>
<degrees>D.O., Pharm.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Cheng</surname>
<given-names>Tina</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Patterson</surname>
<given-names>Helen</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Hainsworth</surname>
<given-names>John D.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Ryan</surname>
<given-names>Charles J.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Sternberg</surname>
<given-names>Cora N.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Ellard</surname>
<given-names>Susan L.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Fléhon</surname>
<given-names>Aude</given-names>
</name>
<degrees>M.D., Ph.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Saleh</surname>
<given-names>Mansoor</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Scholz</surname>
<given-names>Mark</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Efstathiou</surname>
<given-names>Eleni</given-names>
</name>
<degrees>M.D., Ph.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Zivi</surname>
<given-names>Andrea</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Bianchini</surname>
<given-names>Diletta</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Loriot</surname>
<given-names>Yohann</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Chieffo</surname>
<given-names>Nicole</given-names>
</name>
<degrees>M.B.A.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Kheoh</surname>
<given-names>Thian</given-names>
</name>
<degrees>Ph.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Haqq</surname>
<given-names>Christopher M.</given-names>
</name>
<degrees>M.D., Ph.D.</degrees>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Scher</surname>
<given-names>Howard I.</given-names>
</name>
<degrees>M.D.</degrees>
</contrib>
<contrib contrib-type="author">
<collab>for the COU-AA-301 Investigators</collab>
<xref ref-type="fn" rid="FN1">*</xref>
</contrib>
<aff id="A1">Institute of Cancer Research and Royal Marsden Hospital, Sutton (J.S.B., A.Z., D.B.), Institute of Cancer Sciences, Glasgow (R.J.J.), Cardiff University, Velindre Hospital, Cardiff (J.N.S.), and Cambridge (H.P.) — all in the United Kingdom; M.D. Anderson Cancer Center, Houston (C.J.L., E.E.); Ortho Biotech Oncology Research and Development (a unit of Cougar Biotechnology), Los Angeles (A.M., N.C., T.K., C.M.H.); Institut Gustave Roussy, Villejuif (K.F., Y.L.), and Centre Léon Bérard, Lyon (A.F.) — both in France; Cross Cancer Institute, Edmonton, AB (S.N.), BC Cancer Agency, Vancouver Cancer Centre, Vancouver (K.N.C.), University of Calgary, Calgary, AB (T.C.), and BC Cancer Agency, Centre for the Southern Interior, Kelowna (S.L.E.) — all in Canada; Oncology Hematology Consultants, Sarasota, FL (L.C.); Nevada Cancer Institute, Las Vegas (O.B.G.); University of Montreal, Montreal (F.S.); Haematology and Oncology Clinics of Australasia, Milton, Australia (P.M.); UCL Cancer Institute, London (S.H.); University of Colorado Cancer Center, Aurora (T.W.F.); Texas Oncology–Baylor Charles A. Sammons Cancer Center, Dallas (T.E.H.); Sarah Cannon Research Institute, Nashville (J.D.H.); Helen Diller Family Comprehensive Cancer Center, University of California–San Francisco, San Francisco (C.J.R.); San Camillo and Forlanini Hospitals, Rome (C.N.S.); Georgia Cancer Specialists, Atlanta (M. Saleh); Prostate Oncology Specialists, Marina del Rey, CA (M. Scholz); and Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College, New York (H.I.S.)</aff>
</contrib-group>
<author-notes>
<corresp id="cor1">Address reprint requests to Dr. de Bono at the Institute of Cancer Research and Royal Marsden Hospital, Downs Rd., Sutton, Surrey SM2 5PT, United Kingdom, or at
<email>johann.de-bono@icr.ac.uk</email>
</corresp>
</author-notes>
<pub-date pub-type="nihms-submitted">
<day>15</day>
<month>9</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="ppub">
<day>26</day>
<month>5</month>
<year>2011</year>
</pub-date>
<pub-date pub-type="pmc-release">
<day>15</day>
<month>10</month>
<year>2012</year>
</pub-date>
<volume>364</volume>
<issue>21</issue>
<fpage>1995</fpage>
<lpage>2005</lpage>
<permissions>
<copyright-statement>Copyright © 2011 Massachusetts Medical Society.</copyright-statement>
<copyright-year>2011</copyright-year>
</permissions>
<abstract>
<sec id="S1">
<title>BACKGROUND</title>
<p id="P1">Biosynthesis of extragonadal androgen may contribute to the progression of castration-resistant prostate cancer. We evaluated whether abiraterone acetate, an inhibitor of androgen biosynthesis, prolongs overall survival among patients with metastatic castration-resistant prostate cancer who have received chemotherapy.</p>
</sec>
<sec id="S2">
<title>METHODS</title>
<p id="P2">We randomly assigned, in a 2:1 ratio, 1195 patients who had previously received docetaxel to receive 5 mg of prednisone twice daily with either 1000 mg of abiraterone acetate (797 patients) or placebo (398 patients). The primary end point was overall survival. The secondary end points included time to prostate-specific antigen (PSA) progression (elevation in the PSA level according to prespecified criteria), progression-free survival according to radiologic findings based on prespecified criteria, and the PSA response rate.</p>
</sec>
<sec id="S3">
<title>RESULTS</title>
<p id="P3">After a median follow-up of 12.8 months, overall survival was longer in the abiraterone acetate–prednisone group than in the placebo–prednisone group (14.8 months vs. 10.9 months; hazard ratio, 0.65; 95% confidence interval, 0.54 to 0.77; P<0.001). Data were unblinded at the interim analysis, since these results exceeded the preplanned criteria for study termination. All secondary end points, including time to PSA progression (10.2 vs. 6.6 months; P<0.001), progression-free survival (5.6 months vs. 3.6 months; P<0.001), and PSA response rate (29% vs. 6%, P<0.001), favored the treatment group. Mineralocorticoid-related adverse events, including fluid retention, hypertension, and hypokalemia, were more frequently reported in the abiraterone acetate–prednisone group than in the placebo–prednisone group.</p>
</sec>
<sec id="S4">
<title>CONCLUSIONS</title>
<p id="P4">The inhibition of androgen biosynthesis by abiraterone acetate prolonged overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy. (Funded by Cougar Biotechnology; COU-AA-301 ClinicalTrials.gov number, NCT00638690.)</p>
</sec>
</abstract>
<funding-group>
<award-group>
<funding-source country="United States">National Cancer Institute : NCI</funding-source>
<award-id>P50 CA092629 || CA</award-id>
</award-group>
</funding-group>
</article-meta>
</front>
</pmc>
</record>

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