Abiraterone and Increased Survival in Metastatic Prostate Cancer
Identifieur interne : 006D67 ( Main/Exploration ); précédent : 006D66; suivant : 006D68Abiraterone and Increased Survival in Metastatic Prostate Cancer
Auteurs : Johann S. De Bono [Royaume-Uni] ; Christopher J. Logothetis [États-Unis] ; Arturo Molina [États-Unis] ; Karim Fizazi [France] ; Scott North [États-Unis] ; Luis Chu [États-Unis] ; Kim N. Chi [États-Unis] ; Robertj. Jones [Royaume-Uni] ; Oscar B. Jr Goodman [États-Unis] ; Fred Saad [Canada] ; John N. Staffurth [Royaume-Uni] ; Paul Mainwaring [Australie] ; Stephen Harland [Royaume-Uni] ; Thomas W. Flaig [États-Unis] ; Thomas E. Hutson [États-Unis] ; Tina Cheng [États-Unis] ; Helen Patterson ; John D. Hainsworth [États-Unis] ; Charlesj. Ryan [États-Unis] ; Cora N. Sternberg [Italie] ; Susan L. Ellard [Canada] ; Aude Flechon [France] ; Mansoor Saleh [États-Unis] ; Mark Scholz [États-Unis] ; Eleni Efstathiou [États-Unis] ; Andrea Zivi [Royaume-Uni] ; Diletta Bianchini [Royaume-Uni] ; Yohann Loriot [France] ; Nicole Chieffo [États-Unis] ; Thian Kheoh [États-Unis] ; Christopher M. Haqq [États-Unis] ; Howard I. Scher [États-Unis]Source :
- The New England journal of medicine [ 0028-4793 ] ; 2011.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Médecine.
English descriptors
- KwdEn :
Abstract
BACKGROUND 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. METHODS 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. RESULTS 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 pre-planned 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. CONCLUSIONS 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.).
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Affiliations:
- Australie, Canada, France, Italie, Royaume-Uni, États-Unis
- Alberta, Angleterre, Auvergne-Rhône-Alpes, Californie, Grand Londres, Latium, Nevada, Québec, Rhône-Alpes, Texas, État de New York
- Calgary, Dallas, Houston, Las Vegas, Londres, Los Angeles, Lyon, Montréal, Rome, San Francisco
- Université de Calgary
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Sternberg</name><affiliation wicri:level="3"><inist:fA14 i1="21"><s1>San Camillo and Forlanini Hospitals</s1><s2>Rome</s2><s3>ITA</s3><sZ>20 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Ellard, Susan L" sort="Ellard, Susan L" uniqKey="Ellard S" first="Susan L." last="Ellard">Susan L. 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Scher</name><affiliation wicri:level="2"><inist:fA14 i1="24"><s1>Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College</s1><s2>New York</s2><s3>USA</s3><sZ>32 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">11-0256944</idno><date when="2011">2011</date><idno type="stanalyst">PASCAL 11-0256944 INIST</idno><idno type="RBID">Pascal:11-0256944</idno><idno type="wicri:Area/PascalFrancis/Corpus">001D20</idno><idno type="wicri:Area/PascalFrancis/Curation">004223</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001D83</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001D83</idno><idno type="wicri:doubleKey">0028-4793:2011:De Bono J:abiraterone:and:increased</idno><idno type="wicri:Area/Main/Merge">007234</idno><idno type="wicri:source">PMC</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3471149</idno><idno type="RBID">PMC:3471149</idno><idno type="wicri:Area/Pmc/Corpus">001C78</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001C78</idno><idno type="wicri:Area/Pmc/Curation">001B36</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">001B36</idno><idno type="wicri:Area/Pmc/Checkpoint">002420</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">002420</idno><idno type="wicri:Area/Ncbi/Merge">000A75</idno><idno type="wicri:Area/Ncbi/Curation">000A75</idno><idno type="wicri:Area/Ncbi/Checkpoint">000A75</idno><idno type="wicri:doubleKey">0028-4793:2011:De Bono J:abiraterone:and:increased</idno><idno type="wicri:Area/Main/Merge">006611</idno><idno type="wicri:Area/Main/Curation">006D67</idno><idno type="wicri:Area/Main/Exploration">006D67</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute of Cancer Research and Royal Marsden Hospital</s1><s2>Sutton</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>26 aut.</sZ><sZ>27 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Institute of Cancer Research and Royal Marsden Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Anderson Cancer Center</s1><s2>Houston</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Ortho Biotech Oncology Research and Development</s1><s2>Los Angeles</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>29 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Institut Gustave Roussy</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>4 aut.</sZ><sZ>28 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Institut Gustave Roussy</wicri:noRegion><wicri:noRegion>Institut Gustave Roussy</wicri:noRegion></affiliation></author><author><name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Cross Cancer Institute</s1><s2>Edmonton, AB</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Cross Cancer Institute</wicri:noRegion></affiliation></author><author><name sortKey="Chu, Luis" sort="Chu, Luis" uniqKey="Chu L" first="Luis" last="Chu">Luis Chu</name><affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Oncology Hematology Consultants</s1><s2>Sarasota, FL</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Oncology Hematology Consultants</wicri:noRegion></affiliation></author><author><name sortKey="Chi, Kim N" sort="Chi, Kim N" uniqKey="Chi K" first="Kim N." last="Chi">Kim N. Chi</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>BC Cancer Agency, Vancouver Cancer Centre</s1><s2>Vancouver</s2><s3>USA</s3><sZ>7 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Vancouver</wicri:noRegion></affiliation></author><author><name sortKey="Jones, Robertj" sort="Jones, Robertj" uniqKey="Jones R" first="Robertj." last="Jones">Robertj. Jones</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Institute of Cancer Sciences, Glasgow , Cardiff University</s1><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Institute of Cancer Sciences, Glasgow , Cardiff University</wicri:noRegion></affiliation></author><author><name sortKey="Goodman, Oscar B Jr" sort="Goodman, Oscar B Jr" uniqKey="Goodman O" first="Oscar B. Jr" last="Goodman">Oscar B. Jr Goodman</name><affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Nevada Cancer Institute</s1><s2>Las Vegas</s2><s3>USA</s3><sZ>9 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Las Vegas</settlement><region type="state">Nevada</region></placeName></affiliation></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name><affiliation wicri:level="3"><inist:fA14 i1="14"><s1>University of Montreal</s1><s2>Montreal</s2><s3>CAN</s3><sZ>10 aut.</sZ></inist:fA14><country>Canada</country><placeName><settlement type="city">Montréal</settlement><region type="state">Québec</region></placeName></affiliation></author><author><name sortKey="Staffurth, John N" sort="Staffurth, John N" uniqKey="Staffurth J" first="John N." last="Staffurth">John N. Staffurth</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Velindre Hospital</s1><s2>Cardiff</s2><s3>GBR</s3><sZ>11 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Velindre Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Haematology and Oncology Clinics of Australasia</s1><s2>Milton</s2><s3>AUS</s3><sZ>12 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Haematology and Oncology Clinics of Australasia</wicri:noRegion></affiliation></author><author><name sortKey="Harland, Stephen" sort="Harland, Stephen" uniqKey="Harland S" first="Stephen" last="Harland">Stephen Harland</name><affiliation wicri:level="3"><inist:fA14 i1="16"><s1>UCL Cancer Institute</s1><s2>London</s2><s3>GBR</s3><sZ>13 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>University of Colorado Cancer Center</s1><s2>Aurora</s2><s3>USA</s3><sZ>14 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>University of Colorado Cancer Center</wicri:noRegion></affiliation></author><author><name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name><affiliation wicri:level="3"><inist:fA14 i1="18"><s1>Texas Oncology-Baylor Charles A. Sammons Cancer Center</s1><s2>Dallas</s2><s3>USA</s3><sZ>15 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Dallas</settlement><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Cheng, Tina" sort="Cheng, Tina" uniqKey="Cheng T" first="Tina" last="Cheng">Tina Cheng</name><affiliation wicri:level="4"><inist:fA14 i1="10"><s1>University of Calgary</s1><s2>Calgary, AB</s2><s3>USA</s3><sZ>16 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Calgary</settlement><region type="state">Alberta</region></placeName><orgName type="university">Université de Calgary</orgName></affiliation></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><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Sarah Cannon Research Institute</s1><s2>Nashville</s2><s3>USA</s3><sZ>18 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Sarah Cannon Research Institute</wicri:noRegion></affiliation></author><author><name sortKey="Ryan, Charlesj" sort="Ryan, Charlesj" uniqKey="Ryan C" first="Charlesj." last="Ryan">Charlesj. Ryan</name><affiliation wicri:level="3"><inist:fA14 i1="20"><s1>Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco</s1><s2>San Francisco</s2><s3>USA</s3><sZ>19 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">San Francisco</settlement><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Sternberg, Cora N" sort="Sternberg, Cora N" uniqKey="Sternberg C" first="Cora N." last="Sternberg">Cora N. Sternberg</name><affiliation wicri:level="3"><inist:fA14 i1="21"><s1>San Camillo and Forlanini Hospitals</s1><s2>Rome</s2><s3>ITA</s3><sZ>20 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Ellard, Susan L" sort="Ellard, Susan L" uniqKey="Ellard S" first="Susan L." last="Ellard">Susan L. Ellard</name><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>BC Cancer Agency, Centre for the Southern Interior</s1><s2>Kelowna</s2><s3>CAN</s3><sZ>21 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Kelowna</wicri:noRegion></affiliation></author><author><name sortKey="Flechon, Aude" sort="Flechon, Aude" uniqKey="Flechon A" first="Aude" last="Flechon">Aude Flechon</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Centre Léon Bérard</s1><s2>Lyon</s2><s3>FRA</s3><sZ>22 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Saleh, Mansoor" sort="Saleh, Mansoor" uniqKey="Saleh M" first="Mansoor" last="Saleh">Mansoor Saleh</name><affiliation wicri:level="1"><inist:fA14 i1="22"><s1>Georgia Cancer Specialists</s1><s2>Atlanta</s2><s3>USA</s3><sZ>23 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Georgia Cancer Specialists</wicri:noRegion></affiliation></author><author><name sortKey="Scholz, Mark" sort="Scholz, Mark" uniqKey="Scholz M" first="Mark" last="Scholz">Mark Scholz</name><affiliation wicri:level="1"><inist:fA14 i1="23"><s1>Prostate Oncology Specialists</s1><s2>Marina del Rey, CA</s2><s3>USA</s3><sZ>24 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Prostate Oncology Specialists</wicri:noRegion></affiliation></author><author><name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Anderson Cancer Center</s1><s2>Houston</s2><s3>USA</s3><sZ>2 aut.</sZ><sZ>25 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Houston</settlement><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Zivi, Andrea" sort="Zivi, Andrea" uniqKey="Zivi A" first="Andrea" last="Zivi">Andrea Zivi</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute of Cancer Research and Royal Marsden Hospital</s1><s2>Sutton</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>26 aut.</sZ><sZ>27 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Institute of Cancer Research and Royal Marsden Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Bianchini, Diletta" sort="Bianchini, Diletta" uniqKey="Bianchini D" first="Diletta" last="Bianchini">Diletta Bianchini</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Institute of Cancer Research and Royal Marsden Hospital</s1><s2>Sutton</s2><s3>GBR</s3><sZ>1 aut.</sZ><sZ>26 aut.</sZ><sZ>27 aut.</sZ></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Institute of Cancer Research and Royal Marsden Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Loriot, Yohann" sort="Loriot, Yohann" uniqKey="Loriot Y" first="Yohann" last="Loriot">Yohann Loriot</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Institut Gustave Roussy</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>4 aut.</sZ><sZ>28 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Institut Gustave Roussy</wicri:noRegion><wicri:noRegion>Institut Gustave Roussy</wicri:noRegion></affiliation></author><author><name sortKey="Chieffo, Nicole" sort="Chieffo, Nicole" uniqKey="Chieffo N" first="Nicole" last="Chieffo">Nicole Chieffo</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Ortho Biotech Oncology Research and Development</s1><s2>Los Angeles</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>29 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Ortho Biotech Oncology Research and Development</s1><s2>Los Angeles</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>29 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Haqq, Christopher M" sort="Haqq, Christopher M" uniqKey="Haqq C" first="Christopher M." last="Haqq">Christopher M. Haqq</name><affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Ortho Biotech Oncology Research and Development</s1><s2>Los Angeles</s2><s3>USA</s3><sZ>3 aut.</sZ><sZ>29 aut.</sZ><sZ>30 aut.</sZ><sZ>31 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Los Angeles</settlement><region type="state">Californie</region></placeName></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="2"><inist:fA14 i1="24"><s1>Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College</s1><s2>New York</s2><s3>USA</s3><sZ>32 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author></analytic><series><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">The New England journal of medicine</title><title level="j" type="abbreviated">N. Engl. j. med.</title><idno type="ISSN">0028-4793</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Abiraterone</term><term>Advanced stage</term><term>Medicine</term><term>Metastasis</term><term>Metastatic</term><term>Prostate cancer</term><term>Survival</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Abiratérone</term><term>Survie</term><term>Métastase</term><term>Cancer de la prostate</term><term>Stade avancé</term><term>Métastatique</term><term>Médecine</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Médecine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND 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. METHODS 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. RESULTS 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 pre-planned 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. CONCLUSIONS 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.).</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li><li>Italie</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Alberta</li><li>Angleterre</li><li>Auvergne-Rhône-Alpes</li><li>Californie</li><li>Grand Londres</li><li>Latium</li><li>Nevada</li><li>Québec</li><li>Rhône-Alpes</li><li>Texas</li><li>État de New York</li></region><settlement><li>Calgary</li><li>Dallas</li><li>Houston</li><li>Las Vegas</li><li>Londres</li><li>Los Angeles</li><li>Lyon</li><li>Montréal</li><li>Rome</li><li>San Francisco</li></settlement><orgName><li>Université de Calgary</li></orgName></list><tree><noCountry><name sortKey="Patterson, Helen" sort="Patterson, Helen" uniqKey="Patterson H" first="Helen" last="Patterson">Helen Patterson</name></noCountry><country name="Royaume-Uni"><noRegion><name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S." last="De Bono">Johann S. De Bono</name></noRegion><name sortKey="Bianchini, Diletta" sort="Bianchini, Diletta" uniqKey="Bianchini D" first="Diletta" last="Bianchini">Diletta Bianchini</name><name sortKey="Harland, Stephen" sort="Harland, Stephen" uniqKey="Harland S" first="Stephen" last="Harland">Stephen Harland</name><name sortKey="Jones, Robertj" sort="Jones, Robertj" uniqKey="Jones R" first="Robertj." last="Jones">Robertj. Jones</name><name sortKey="Staffurth, John N" sort="Staffurth, John N" uniqKey="Staffurth J" first="John N." last="Staffurth">John N. Staffurth</name><name sortKey="Zivi, Andrea" sort="Zivi, Andrea" uniqKey="Zivi A" first="Andrea" last="Zivi">Andrea Zivi</name></country><country name="États-Unis"><region name="Texas"><name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name></region><name sortKey="Cheng, Tina" sort="Cheng, Tina" uniqKey="Cheng T" first="Tina" last="Cheng">Tina Cheng</name><name sortKey="Chi, Kim N" sort="Chi, Kim N" uniqKey="Chi K" first="Kim N." last="Chi">Kim N. Chi</name><name sortKey="Chieffo, Nicole" sort="Chieffo, Nicole" uniqKey="Chieffo N" first="Nicole" last="Chieffo">Nicole Chieffo</name><name sortKey="Chu, Luis" sort="Chu, Luis" uniqKey="Chu L" first="Luis" last="Chu">Luis Chu</name><name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name><name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name><name sortKey="Goodman, Oscar B Jr" sort="Goodman, Oscar B Jr" uniqKey="Goodman O" first="Oscar B. Jr" last="Goodman">Oscar B. Jr Goodman</name><name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D." last="Hainsworth">John D. Hainsworth</name><name sortKey="Haqq, Christopher M" sort="Haqq, Christopher M" uniqKey="Haqq C" first="Christopher M." last="Haqq">Christopher M. Haqq</name><name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name><name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name><name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name><name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name><name sortKey="Ryan, Charlesj" sort="Ryan, Charlesj" uniqKey="Ryan C" first="Charlesj." last="Ryan">Charlesj. Ryan</name><name sortKey="Saleh, Mansoor" sort="Saleh, Mansoor" uniqKey="Saleh M" first="Mansoor" last="Saleh">Mansoor Saleh</name><name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name><name sortKey="Scholz, Mark" sort="Scholz, Mark" uniqKey="Scholz M" first="Mark" last="Scholz">Mark Scholz</name></country><country name="France"><noRegion><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name></noRegion><name sortKey="Flechon, Aude" sort="Flechon, Aude" uniqKey="Flechon A" first="Aude" last="Flechon">Aude Flechon</name><name sortKey="Loriot, Yohann" sort="Loriot, Yohann" uniqKey="Loriot Y" first="Yohann" last="Loriot">Yohann Loriot</name></country><country name="Canada"><region name="Québec"><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name></region><name sortKey="Ellard, Susan L" sort="Ellard, Susan L" uniqKey="Ellard S" first="Susan L." last="Ellard">Susan L. Ellard</name></country><country name="Australie"><noRegion><name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name></noRegion></country><country name="Italie"><region name="Latium"><name sortKey="Sternberg, Cora N" sort="Sternberg, Cora N" uniqKey="Sternberg C" first="Cora N." last="Sternberg">Cora N. Sternberg</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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