AustralieFrV1, Main, Exploration, bibRecord, 005B45

Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy

Identifieur interne : 005B45 ( Main/Exploration ); précédent : 005B44; suivant : 005B46

Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy

Auteurs : Howard I. Scher [États-Unis] ; Karim Fizazi [France] ; Fred Saad [États-Unis] ; Mary-Ellen Taplin [États-Unis] ; Cora N. Sternberg [Italie] ; Kurt Miller [Allemagne] ; Ronald De Wit [Pays-Bas] ; Peter Mulders [Pays-Bas] ; Kim N. Chi [Canada] ; Neal D. Shore [États-Unis] ; Andrew J. Armstrong [États-Unis] ; Thomas W. Flaig [États-Unis] ; Aude Flechon [France] ; Paul Mainwaring [Australie] ; Mark Fleming [États-Unis] ; John D. Hainsworth [États-Unis] ; Mohammad Hirmand [États-Unis] ; Bryan Selby [États-Unis] ; Lynn Seely [États-Unis] ; Johann S. De Bono [Royaume-Uni]

Source :

The New England journal of medicine [ 0028-4793 ] ; 2012.

RBID : Pascal:12-0380483

Descripteurs français

Pascal (Inist)
- Cancer de la prostate, Survie, Traitement, Chimiothérapie, Médecine.
Wicri :
- topic : Médecine.

English descriptors

KwdEn :
- Chemotherapy, Medicine, Prostate cancer, Survival, Treatment.

Abstract

BACKGROUND Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth. We aimed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy. METHODS In our phase 3, double-blind, placebo-controlled trial, we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity. We randomly assigned them, in a 2:1 ratio, to receive oral enzalutamide at a dose of 160 mg per day (800 patients) or placebo (399 patients). The primary end point was overall survival. RESULTS The study was stopped after a planned interim analysis at the time of 520 deaths. The median overall survival was 18.4 months (95% confidence interval [CI], 17.3 to not yet reached) in the enzalutamide group versus 13.6 months (95% CI, 11.3 to 15.8) in the placebo group (hazard ratio for death in the enzalutamide group, 0.63; 95% CI, 0.53 to 0.75; P<0.001). The superiority of enzalutamide over placebo was shown with respect to all secondary end points: the proportion of patients with a reduction in the prostate-specific antigen (PSA) level by 50% or more (54% vs. 2%, P<0.001), the soft-tissue response rate (29% vs. 4%, P<0.001), the quality-of-life response rate (43% vs. 18%, P<0.001), the time to PSA progression (8.3 vs. 3.0 months; hazard ratio, 0.25; P<0.001), radiographic progression-free survival (8.3 vs. 2.9 months; hazard ratio, 0.40; P<0.001), and the time to the first skeletal-related event (16.7 vs. 13.3 months; hazard ratio, 0.69; P<0.001). Rates of fatigue, diarrhea, and hot flashes were higher in the enzalutamide group. Seizures were reported in five patients (0.6%) receiving enzalutamide. CONCLUSIONS Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy.

Affiliations:

Allemagne, Australie, Canada, France, Italie, Pays-Bas, Royaume-Uni, États-Unis
Auvergne-Rhône-Alpes, Berlin, Californie, Gueldre, Hollande-Méridionale, Latium, Massachusetts, Québec, Rhône-Alpes, État de New York
Berlin, Boston, Lyon, Montréal, Nimègue, Rome, Rotterdam, San Francisco

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Le document en format XML

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<author><name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S." last="De Bono">Johann S. De Bono</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy</title>
<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="01"><s1>Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College</s1>
<s2>New York</s2>
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<placeName><region type="state">État de New York</region>
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<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="02"><s1>Institut Gustave Roussy, University of Paris Sud</s1>
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<author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
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<author><name sortKey="Taplin, Mary Ellen" sort="Taplin, Mary Ellen" uniqKey="Taplin M" first="Mary-Ellen" last="Taplin">Mary-Ellen Taplin</name>
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<author><name sortKey="Miller, Kurt" sort="Miller, Kurt" uniqKey="Miller K" first="Kurt" last="Miller">Kurt Miller</name>
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<author><name sortKey="Chi, Kim N" sort="Chi, Kim N" uniqKey="Chi K" first="Kim N." last="Chi">Kim N. Chi</name>
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<author><name sortKey="Shore, Neal D" sort="Shore, Neal D" uniqKey="Shore N" first="Neal D." last="Shore">Neal D. Shore</name>
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<author><name sortKey="Armstrong, Andrew J" sort="Armstrong, Andrew J" uniqKey="Armstrong A" first="Andrew J." last="Armstrong">Andrew J. Armstrong</name>
<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Duke Cancer Institute, Duke University</s1>
<s2>Durham, NC</s2>
<s3>USA</s3>
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<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="12"><s1>University of Colorado Cancer Center</s1>
<s2>Aurora</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
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<country>États-Unis</country>
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<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="13"><s1>Centre Leon Bérard-Centre Regional de Lutte contre le Cancer Rhône-Alpes</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
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</placeName>
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<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="14"><s1>Mater Private Hospital</s1>
<s2>South Brisbane</s2>
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<sZ>14 aut.</sZ>
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<country>Australie</country>
<wicri:noRegion>Mater Private Hospital</wicri:noRegion>
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</author>
<author><name sortKey="Fleming, Mark" sort="Fleming, Mark" uniqKey="Fleming M" first="Mark" last="Fleming">Mark Fleming</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Virginia Oncology Associates</s1>
<s2>Norfolk</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Virginia Oncology Associates</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D." last="Hainsworth">John D. Hainsworth</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Sarah Cannon Research Institute</s1>
<s2>Nashville</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Sarah Cannon Research Institute</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hirmand, Mohammad" sort="Hirmand, Mohammad" uniqKey="Hirmand M" first="Mohammad" last="Hirmand">Mohammad Hirmand</name>
<affiliation wicri:level="3"><inist:fA14 i1="17"><s1>Medivation</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<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="Selby, Bryan" sort="Selby, Bryan" uniqKey="Selby B" first="Bryan" last="Selby">Bryan Selby</name>
<affiliation wicri:level="3"><inist:fA14 i1="17"><s1>Medivation</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<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="Seely, Lynn" sort="Seely, Lynn" uniqKey="Seely L" first="Lynn" last="Seely">Lynn Seely</name>
<affiliation wicri:level="3"><inist:fA14 i1="17"><s1>Medivation</s1>
<s2>San Francisco</s2>
<s3>USA</s3>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<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="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="18"><s1>Institute for Cancer Research and Royal Marsden Hospital</s1>
<s2>Sutton</s2>
<s3>GBR</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Institute for Cancer Research and Royal Marsden Hospital</wicri:noRegion>
</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="2012">2012</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>Chemotherapy</term>
<term>Medicine</term>
<term>Prostate cancer</term>
<term>Survival</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Cancer de la prostate</term>
<term>Survie</term>
<term>Traitement</term>
<term>Chimiothérapie</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 Enzalutamide (formerly called MDV3100) targets multiple steps in the androgen-receptor-signaling pathway, the major driver of prostate-cancer growth. We aimed to evaluate whether enzalutamide prolongs survival in men with castration-resistant prostate cancer after chemotherapy. METHODS In our phase 3, double-blind, placebo-controlled trial, we stratified 1199 men with castration-resistant prostate cancer after chemotherapy according to the Eastern Cooperative Oncology Group performance-status score and pain intensity. We randomly assigned them, in a 2:1 ratio, to receive oral enzalutamide at a dose of 160 mg per day (800 patients) or placebo (399 patients). The primary end point was overall survival. RESULTS The study was stopped after a planned interim analysis at the time of 520 deaths. The median overall survival was 18.4 months (95% confidence interval [CI], 17.3 to not yet reached) in the enzalutamide group versus 13.6 months (95% CI, 11.3 to 15.8) in the placebo group (hazard ratio for death in the enzalutamide group, 0.63; 95% CI, 0.53 to 0.75; P<0.001). The superiority of enzalutamide over placebo was shown with respect to all secondary end points: the proportion of patients with a reduction in the prostate-specific antigen (PSA) level by 50% or more (54% vs. 2%, P<0.001), the soft-tissue response rate (29% vs. 4%, P<0.001), the quality-of-life response rate (43% vs. 18%, P<0.001), the time to PSA progression (8.3 vs. 3.0 months; hazard ratio, 0.25; P<0.001), radiographic progression-free survival (8.3 vs. 2.9 months; hazard ratio, 0.40; P<0.001), and the time to the first skeletal-related event (16.7 vs. 13.3 months; hazard ratio, 0.69; P<0.001). Rates of fatigue, diarrhea, and hot flashes were higher in the enzalutamide group. Seizures were reported in five patients (0.6%) receiving enzalutamide. CONCLUSIONS Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer after chemotherapy.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Berlin</li>
<li>Californie</li>
<li>Gueldre</li>
<li>Hollande-Méridionale</li>
<li>Latium</li>
<li>Massachusetts</li>
<li>Québec</li>
<li>Rhône-Alpes</li>
<li>État de New York</li>
</region>
<settlement><li>Berlin</li>
<li>Boston</li>
<li>Lyon</li>
<li>Montréal</li>
<li>Nimègue</li>
<li>Rome</li>
<li>Rotterdam</li>
<li>San Francisco</li>
</settlement>
</list>
<tree><country name="États-Unis"><region name="État de New York"><name sortKey="Scher, Howard I" sort="Scher, Howard I" uniqKey="Scher H" first="Howard I." last="Scher">Howard I. Scher</name>
</region>
<name sortKey="Armstrong, Andrew J" sort="Armstrong, Andrew J" uniqKey="Armstrong A" first="Andrew J." last="Armstrong">Andrew J. Armstrong</name>
<name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name>
<name sortKey="Fleming, Mark" sort="Fleming, Mark" uniqKey="Fleming M" first="Mark" last="Fleming">Mark Fleming</name>
<name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D." last="Hainsworth">John D. Hainsworth</name>
<name sortKey="Hirmand, Mohammad" sort="Hirmand, Mohammad" uniqKey="Hirmand M" first="Mohammad" last="Hirmand">Mohammad Hirmand</name>
<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
<name sortKey="Seely, Lynn" sort="Seely, Lynn" uniqKey="Seely L" first="Lynn" last="Seely">Lynn Seely</name>
<name sortKey="Selby, Bryan" sort="Selby, Bryan" uniqKey="Selby B" first="Bryan" last="Selby">Bryan Selby</name>
<name sortKey="Shore, Neal D" sort="Shore, Neal D" uniqKey="Shore N" first="Neal D." last="Shore">Neal D. Shore</name>
<name sortKey="Taplin, Mary Ellen" sort="Taplin, Mary Ellen" uniqKey="Taplin M" first="Mary-Ellen" last="Taplin">Mary-Ellen Taplin</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>
</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>
<country name="Allemagne"><region name="Berlin"><name sortKey="Miller, Kurt" sort="Miller, Kurt" uniqKey="Miller K" first="Kurt" last="Miller">Kurt Miller</name>
</region>
</country>
<country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="De Wit, Ronald" sort="De Wit, Ronald" uniqKey="De Wit R" first="Ronald" last="De Wit">Ronald De Wit</name>
</region>
<name sortKey="Mulders, Peter" sort="Mulders, Peter" uniqKey="Mulders P" first="Peter" last="Mulders">Peter Mulders</name>
</country>
<country name="Canada"><noRegion><name sortKey="Chi, Kim N" sort="Chi, Kim N" uniqKey="Chi K" first="Kim N." last="Chi">Kim N. Chi</name>
</noRegion>
</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="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>
</country>
</tree>
</affiliations>
</record>

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Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy

Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy

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