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Abiraterone and Increased Survival in Metastatic Prostate Cancer

Identifieur interne : 001D20 ( PascalFrancis/Corpus ); précédent : 001D19; suivant : 001D21

Abiraterone and Increased Survival in Metastatic Prostate Cancer

Auteurs : Johann S. De Bono ; Christopher J. Logothetis ; Arturo Molina ; Karim Fizazi ; Scott North ; Luis Chu ; Kim N. Chi ; Robertj. Jones ; Oscar B. Jr Goodman ; Fred Saad ; John N. Staffurth ; Paul Mainwaring ; Stephen Harland ; Thomas W. Flaig ; Thomas E. Hutson ; Tina Cheng ; Helen Patterson ; John D. Hainsworth ; Charlesj. Ryan ; Cora N. Sternberg ; Susan L. Ellard ; Aude Flechon ; Mansoor Saleh ; Mark Scholz ; Eleni Efstathiou ; Andrea Zivi ; Diletta Bianchini ; Yohann Loriot ; Nicole Chieffo ; Thian Kheoh ; Christopher M. Haqq ; Howard I. Scher

Source :

RBID : Pascal:11-0256944

Descripteurs français

English descriptors

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.).

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A06       @2 21
A08 01  1  ENG  @1 Abiraterone and Increased Survival in Metastatic Prostate Cancer
A11 01  1    @1 DE BONO (Johann S.)
A11 02  1    @1 LOGOTHETIS (Christopher J.)
A11 03  1    @1 MOLINA (Arturo)
A11 04  1    @1 FIZAZI (Karim)
A11 05  1    @1 NORTH (Scott)
A11 06  1    @1 CHU (Luis)
A11 07  1    @1 CHI (Kim N.)
A11 08  1    @1 JONES (RobertJ.)
A11 09  1    @1 GOODMAN (Oscar B. JR)
A11 10  1    @1 SAAD (Fred)
A11 11  1    @1 STAFFURTH (John N.)
A11 12  1    @1 MAINWARING (Paul)
A11 13  1    @1 HARLAND (Stephen)
A11 14  1    @1 FLAIG (Thomas W.)
A11 15  1    @1 HUTSON (Thomas E.)
A11 16  1    @1 CHENG (Tina)
A11 17  1    @1 PATTERSON (Helen)
A11 18  1    @1 HAINSWORTH (John D.)
A11 19  1    @1 RYAN (CharlesJ.)
A11 20  1    @1 STERNBERG (Cora N.)
A11 21  1    @1 ELLARD (Susan L.)
A11 22  1    @1 FLECHON (Aude)
A11 23  1    @1 SALEH (Mansoor)
A11 24  1    @1 SCHOLZ (Mark)
A11 25  1    @1 EFSTATHIOU (Eleni)
A11 26  1    @1 ZIVI (Andrea)
A11 27  1    @1 BIANCHINI (Diletta)
A11 28  1    @1 LORIOT (Yohann)
A11 29  1    @1 CHIEFFO (Nicole)
A11 30  1    @1 KHEOH (Thian)
A11 31  1    @1 HAQQ (Christopher M.)
A11 32  1    @1 SCHER (Howard I.)
A14 01      @1 Institute of Cancer Research and Royal Marsden Hospital @2 Sutton @3 GBR @Z 1 aut. @Z 26 aut. @Z 27 aut.
A14 02      @1 Institute of Cancer Sciences, Glasgow , Cardiff University @3 GBR @Z 8 aut.
A14 03      @1 Velindre Hospital @2 Cardiff @3 GBR @Z 11 aut.
A14 04      @1 Anderson Cancer Center @2 Houston @3 USA @Z 2 aut. @Z 25 aut.
A14 05      @1 Ortho Biotech Oncology Research and Development @2 Los Angeles @3 USA @Z 3 aut. @Z 29 aut. @Z 30 aut. @Z 31 aut.
A14 06      @1 Institut Gustave Roussy @2 Villejuif @3 FRA @Z 4 aut. @Z 28 aut.
A14 07      @1 Centre Léon Bérard @2 Lyon @3 FRA @Z 22 aut.
A14 08      @1 Cross Cancer Institute @2 Edmonton, AB @3 USA @Z 5 aut.
A14 09      @1 BC Cancer Agency, Vancouver Cancer Centre @2 Vancouver @3 USA @Z 7 aut.
A14 10      @1 University of Calgary @2 Calgary, AB @3 USA @Z 16 aut.
A14 11      @1 BC Cancer Agency, Centre for the Southern Interior @2 Kelowna @3 CAN @Z 21 aut.
A14 12      @1 Oncology Hematology Consultants @2 Sarasota, FL @3 USA @Z 6 aut.
A14 13      @1 Nevada Cancer Institute @2 Las Vegas @3 USA @Z 9 aut.
A14 14      @1 University of Montreal @2 Montreal @3 CAN @Z 10 aut.
A14 15      @1 Haematology and Oncology Clinics of Australasia @2 Milton @3 AUS @Z 12 aut.
A14 16      @1 UCL Cancer Institute @2 London @3 GBR @Z 13 aut.
A14 17      @1 University of Colorado Cancer Center @2 Aurora @3 USA @Z 14 aut.
A14 18      @1 Texas Oncology-Baylor Charles A. Sammons Cancer Center @2 Dallas @3 USA @Z 15 aut.
A14 19      @1 Sarah Cannon Research Institute @2 Nashville @3 USA @Z 18 aut.
A14 20      @1 Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco @2 San Francisco @3 USA @Z 19 aut.
A14 21      @1 San Camillo and Forlanini Hospitals @2 Rome @3 ITA @Z 20 aut.
A14 22      @1 Georgia Cancer Specialists @2 Atlanta @3 USA @Z 23 aut.
A14 23      @1 Prostate Oncology Specialists @2 Marina del Rey, CA @3 USA @Z 24 aut.
A14 24      @1 Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College @2 New York @3 USA @Z 32 aut.
A17 01  1    @1 COU-AA-301 Investigators @3 INC
A20       @1 1995-2005
A21       @1 2011
A23 01      @0 ENG
A43 01      @1 INIST @2 6013 @5 354000192119870040
A44       @0 0000 @1 © 2011 INIST-CNRS. All rights reserved.
A45       @0 46 ref.
A47 01  1    @0 11-0256944
A60       @1 P
A61       @0 A
A64 01  1    @0 The New England journal of medicine
A66 01      @0 USA
C01 01    ENG  @0 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.).
C02 01  X    @0 002B01
C02 02  X    @0 002B14D02
C02 03  X    @0 002B20B02
C03 01  X  FRE  @0 Abiratérone @2 NK @2 FR @5 01
C03 01  X  ENG  @0 Abiraterone @2 NK @2 FR @5 01
C03 01  X  SPA  @0 Abiraterona @2 NK @2 FR @5 01
C03 02  X  FRE  @0 Survie @5 02
C03 02  X  ENG  @0 Survival @5 02
C03 02  X  SPA  @0 Sobrevivencia @5 02
C03 03  X  FRE  @0 Métastase @5 03
C03 03  X  ENG  @0 Metastasis @5 03
C03 03  X  SPA  @0 Metástasis @5 03
C03 04  X  FRE  @0 Cancer de la prostate @2 NM @5 04
C03 04  X  ENG  @0 Prostate cancer @2 NM @5 04
C03 04  X  SPA  @0 Cáncer de la próstata @2 NM @5 04
C03 05  X  FRE  @0 Stade avancé @5 05
C03 05  X  ENG  @0 Advanced stage @5 05
C03 05  X  SPA  @0 Estadio avanzado @5 05
C03 06  X  FRE  @0 Métastatique @5 06
C03 06  X  ENG  @0 Metastatic @5 06
C03 06  X  SPA  @0 Metastásico @5 06
C03 07  X  FRE  @0 Médecine @5 08
C03 07  X  ENG  @0 Medicine @5 08
C03 07  X  SPA  @0 Medicina @5 08
C07 01  X  FRE  @0 Antiandrogène @5 37
C07 01  X  ENG  @0 Antiandrogen @5 37
C07 01  X  SPA  @0 Antiandrógeno @5 37
C07 02  X  FRE  @0 Antihormone @5 38
C07 02  X  ENG  @0 Antihormone @5 38
C07 02  X  SPA  @0 Antihormona @5 38
C07 03  X  FRE  @0 Tumeur maligne @2 NM @5 39
C07 03  X  ENG  @0 Malignant tumor @2 NM @5 39
C07 03  X  SPA  @0 Tumor maligno @2 NM @5 39
C07 04  X  FRE  @0 Cancer @2 NM
C07 04  X  ENG  @0 Cancer @2 NM
C07 04  X  SPA  @0 Cáncer @2 NM
C07 05  X  FRE  @0 Pathologie de l'appareil génital mâle @5 40
C07 05  X  ENG  @0 Male genital diseases @5 40
C07 05  X  SPA  @0 Aparato genital macho patología @5 40
C07 06  X  FRE  @0 Pathologie de l'appareil urinaire @5 41
C07 06  X  ENG  @0 Urinary system disease @5 41
C07 06  X  SPA  @0 Aparato urinario patología @5 41
C07 07  X  FRE  @0 Pathologie de la prostate @5 42
C07 07  X  ENG  @0 Prostate disease @5 42
C07 07  X  SPA  @0 Prostata patología @5 42
N21       @1 171
N44 01      @1 OTO
N82       @1 OTO

Format Inist (serveur)

NO : PASCAL 11-0256944 INIST
ET : Abiraterone and Increased Survival in Metastatic Prostate Cancer
AU : DE BONO (Johann S.); LOGOTHETIS (Christopher J.); MOLINA (Arturo); FIZAZI (Karim); NORTH (Scott); CHU (Luis); CHI (Kim N.); JONES (RobertJ.); GOODMAN (Oscar B. JR); SAAD (Fred); STAFFURTH (John N.); MAINWARING (Paul); HARLAND (Stephen); FLAIG (Thomas W.); HUTSON (Thomas E.); CHENG (Tina); PATTERSON (Helen); HAINSWORTH (John D.); RYAN (CharlesJ.); STERNBERG (Cora N.); ELLARD (Susan L.); FLECHON (Aude); SALEH (Mansoor); SCHOLZ (Mark); EFSTATHIOU (Eleni); ZIVI (Andrea); BIANCHINI (Diletta); LORIOT (Yohann); CHIEFFO (Nicole); KHEOH (Thian); HAQQ (Christopher M.); SCHER (Howard I.)
AF : Institute of Cancer Research and Royal Marsden Hospital/Sutton/Royaume-Uni (1 aut., 26 aut., 27 aut.); Institute of Cancer Sciences, Glasgow , Cardiff University/Royaume-Uni (8 aut.); Velindre Hospital/Cardiff/Royaume-Uni (11 aut.); Anderson Cancer Center/Houston/Etats-Unis (2 aut., 25 aut.); Ortho Biotech Oncology Research and Development/Los Angeles/Etats-Unis (3 aut., 29 aut., 30 aut., 31 aut.); Institut Gustave Roussy/Villejuif/France (4 aut., 28 aut.); Centre Léon Bérard/Lyon/France (22 aut.); Cross Cancer Institute/Edmonton, AB/Etats-Unis (5 aut.); BC Cancer Agency, Vancouver Cancer Centre/Vancouver/Etats-Unis (7 aut.); University of Calgary/Calgary, AB/Etats-Unis (16 aut.); BC Cancer Agency, Centre for the Southern Interior/Kelowna/Canada (21 aut.); Oncology Hematology Consultants/Sarasota, FL/Etats-Unis (6 aut.); Nevada Cancer Institute/Las Vegas/Etats-Unis (9 aut.); University of Montreal/Montreal/Canada (10 aut.); Haematology and Oncology Clinics of Australasia/Milton/Australie (12 aut.); UCL Cancer Institute/London/Royaume-Uni (13 aut.); University of Colorado Cancer Center/Aurora/Etats-Unis (14 aut.); Texas Oncology-Baylor Charles A. Sammons Cancer Center/Dallas/Etats-Unis (15 aut.); Sarah Cannon Research Institute/Nashville/Etats-Unis (18 aut.); Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco/San Francisco/Etats-Unis (19 aut.); San Camillo and Forlanini Hospitals/Rome/Italie (20 aut.); Georgia Cancer Specialists/Atlanta/Etats-Unis (23 aut.); Prostate Oncology Specialists/Marina del Rey, CA/Etats-Unis (24 aut.); Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College/New York/Etats-Unis (32 aut.)
DT : Publication en série; Niveau analytique
SO : The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2011; Vol. 364; No. 21; Pp. 1995-2005; Bibl. 46 ref.
LA : Anglais
EA : 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.).
CC : 002B01; 002B14D02; 002B20B02
FD : Abiratérone; Survie; Métastase; Cancer de la prostate; Stade avancé; Métastatique; Médecine
FG : Antiandrogène; Antihormone; Tumeur maligne; Cancer; Pathologie de l'appareil génital mâle; Pathologie de l'appareil urinaire; Pathologie de la prostate
ED : Abiraterone; Survival; Metastasis; Prostate cancer; Advanced stage; Metastatic; Medicine
EG : Antiandrogen; Antihormone; Malignant tumor; Cancer; Male genital diseases; Urinary system disease; Prostate disease
SD : Abiraterona; Sobrevivencia; Metástasis; Cáncer de la próstata; Estadio avanzado; Metastásico; Medicina
LO : INIST-6013.354000192119870040
ID : 11-0256944

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Pascal:11-0256944

Le document en format XML

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<sZ>19 aut.</sZ>
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<inist:fA14 i1="21">
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<s2>Rome</s2>
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<s1>Centre Léon Bérard</s1>
<s2>Lyon</s2>
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<inist:fA14 i1="22">
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<s2>Atlanta</s2>
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<sZ>23 aut.</sZ>
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<sZ>24 aut.</sZ>
</inist:fA14>
</affiliation>
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<name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
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<inist:fA14 i1="04">
<s1>Anderson Cancer Center</s1>
<s2>Houston</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
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</inist:fA14>
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<name sortKey="Zivi, Andrea" sort="Zivi, Andrea" uniqKey="Zivi A" first="Andrea" last="Zivi">Andrea Zivi</name>
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<s1>Institute of Cancer Research and Royal Marsden Hospital</s1>
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<sZ>1 aut.</sZ>
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<name sortKey="Bianchini, Diletta" sort="Bianchini, Diletta" uniqKey="Bianchini D" first="Diletta" last="Bianchini">Diletta Bianchini</name>
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<inist:fA14 i1="01">
<s1>Institute of Cancer Research and Royal Marsden Hospital</s1>
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<sZ>1 aut.</sZ>
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<name sortKey="Loriot, Yohann" sort="Loriot, Yohann" uniqKey="Loriot Y" first="Yohann" last="Loriot">Yohann Loriot</name>
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<inist:fA14 i1="06">
<s1>Institut Gustave Roussy</s1>
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<name sortKey="Chieffo, Nicole" sort="Chieffo, Nicole" uniqKey="Chieffo N" first="Nicole" last="Chieffo">Nicole Chieffo</name>
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<inist:fA14 i1="05">
<s1>Ortho Biotech Oncology Research and Development</s1>
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<sZ>3 aut.</sZ>
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<sZ>30 aut.</sZ>
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<name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
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<sZ>30 aut.</sZ>
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</inist:fA14>
</affiliation>
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<name sortKey="Haqq, Christopher M" sort="Haqq, Christopher M" uniqKey="Haqq C" first="Christopher M." last="Haqq">Christopher M. Haqq</name>
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<s1>Ortho Biotech Oncology Research and Development</s1>
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<sZ>30 aut.</sZ>
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</inist:fA14>
</affiliation>
</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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<inist:fA14 i1="24">
<s1>Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College</s1>
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<title xml:lang="en" level="a">Abiraterone and Increased Survival in Metastatic Prostate Cancer</title>
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<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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<inist:fA14 i1="01">
<s1>Institute of Cancer Research and Royal Marsden Hospital</s1>
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<author>
<name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J." last="Logothetis">Christopher J. Logothetis</name>
<affiliation>
<inist:fA14 i1="04">
<s1>Anderson Cancer Center</s1>
<s2>Houston</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
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</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Molina, Arturo" sort="Molina, Arturo" uniqKey="Molina A" first="Arturo" last="Molina">Arturo Molina</name>
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<inist:fA14 i1="05">
<s1>Ortho Biotech Oncology Research and Development</s1>
<s2>Los Angeles</s2>
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<sZ>3 aut.</sZ>
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</affiliation>
</author>
<author>
<name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name>
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<inist:fA14 i1="06">
<s1>Institut Gustave Roussy</s1>
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<sZ>4 aut.</sZ>
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</author>
<author>
<name sortKey="North, Scott" sort="North, Scott" uniqKey="North S" first="Scott" last="North">Scott North</name>
<affiliation>
<inist:fA14 i1="08">
<s1>Cross Cancer Institute</s1>
<s2>Edmonton, AB</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Chu, Luis" sort="Chu, Luis" uniqKey="Chu L" first="Luis" last="Chu">Luis Chu</name>
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<inist:fA14 i1="12">
<s1>Oncology Hematology Consultants</s1>
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<s3>USA</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<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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<inist:fA14 i1="09">
<s1>BC Cancer Agency, Vancouver Cancer Centre</s1>
<s2>Vancouver</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Jones, Robertj" sort="Jones, Robertj" uniqKey="Jones R" first="Robertj." last="Jones">Robertj. Jones</name>
<affiliation>
<inist:fA14 i1="02">
<s1>Institute of Cancer Sciences, Glasgow , Cardiff University</s1>
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</inist:fA14>
</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>
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<inist:fA14 i1="13">
<s1>Nevada Cancer Institute</s1>
<s2>Las Vegas</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name>
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<inist:fA14 i1="14">
<s1>University of Montreal</s1>
<s2>Montreal</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
</affiliation>
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<author>
<name sortKey="Staffurth, John N" sort="Staffurth, John N" uniqKey="Staffurth J" first="John N." last="Staffurth">John N. Staffurth</name>
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<inist:fA14 i1="03">
<s1>Velindre Hospital</s1>
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</affiliation>
</author>
<author>
<name sortKey="Mainwaring, Paul" sort="Mainwaring, Paul" uniqKey="Mainwaring P" first="Paul" last="Mainwaring">Paul Mainwaring</name>
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<inist:fA14 i1="15">
<s1>Haematology and Oncology Clinics of Australasia</s1>
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<sZ>12 aut.</sZ>
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</affiliation>
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<author>
<name sortKey="Harland, Stephen" sort="Harland, Stephen" uniqKey="Harland S" first="Stephen" last="Harland">Stephen Harland</name>
<affiliation>
<inist:fA14 i1="16">
<s1>UCL Cancer Institute</s1>
<s2>London</s2>
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<sZ>13 aut.</sZ>
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</affiliation>
</author>
<author>
<name sortKey="Flaig, Thomas W" sort="Flaig, Thomas W" uniqKey="Flaig T" first="Thomas W." last="Flaig">Thomas W. Flaig</name>
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<inist:fA14 i1="17">
<s1>University of Colorado Cancer Center</s1>
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<sZ>14 aut.</sZ>
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</affiliation>
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<name sortKey="Hutson, Thomas E" sort="Hutson, Thomas E" uniqKey="Hutson T" first="Thomas E." last="Hutson">Thomas E. Hutson</name>
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<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>
</affiliation>
</author>
<author>
<name sortKey="Cheng, Tina" sort="Cheng, Tina" uniqKey="Cheng T" first="Tina" last="Cheng">Tina Cheng</name>
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<inist:fA14 i1="10">
<s1>University of Calgary</s1>
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<name sortKey="Patterson, Helen" sort="Patterson, Helen" uniqKey="Patterson H" first="Helen" last="Patterson">Helen Patterson</name>
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<name sortKey="Hainsworth, John D" sort="Hainsworth, John D" uniqKey="Hainsworth J" first="John D." last="Hainsworth">John D. Hainsworth</name>
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<s1>Sarah Cannon Research Institute</s1>
<s2>Nashville</s2>
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<name sortKey="Ryan, Charlesj" sort="Ryan, Charlesj" uniqKey="Ryan C" first="Charlesj." last="Ryan">Charlesj. Ryan</name>
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<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>
</affiliation>
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<name sortKey="Sternberg, Cora N" sort="Sternberg, Cora N" uniqKey="Sternberg C" first="Cora N." last="Sternberg">Cora N. Sternberg</name>
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<inist:fA14 i1="21">
<s1>San Camillo and Forlanini Hospitals</s1>
<s2>Rome</s2>
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</inist:fA14>
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</author>
<author>
<name sortKey="Ellard, Susan L" sort="Ellard, Susan L" uniqKey="Ellard S" first="Susan L." last="Ellard">Susan L. Ellard</name>
<affiliation>
<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>
</affiliation>
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<author>
<name sortKey="Flechon, Aude" sort="Flechon, Aude" uniqKey="Flechon A" first="Aude" last="Flechon">Aude Flechon</name>
<affiliation>
<inist:fA14 i1="07">
<s1>Centre Léon Bérard</s1>
<s2>Lyon</s2>
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<sZ>22 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author>
<name sortKey="Saleh, Mansoor" sort="Saleh, Mansoor" uniqKey="Saleh M" first="Mansoor" last="Saleh">Mansoor Saleh</name>
<affiliation>
<inist:fA14 i1="22">
<s1>Georgia Cancer Specialists</s1>
<s2>Atlanta</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
</inist:fA14>
</affiliation>
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<name sortKey="Scholz, Mark" sort="Scholz, Mark" uniqKey="Scholz M" first="Mark" last="Scholz">Mark Scholz</name>
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<inist:fA14 i1="23">
<s1>Prostate Oncology Specialists</s1>
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<s3>USA</s3>
<sZ>24 aut.</sZ>
</inist:fA14>
</affiliation>
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<name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name>
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<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>
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<name sortKey="Zivi, Andrea" sort="Zivi, Andrea" uniqKey="Zivi A" first="Andrea" last="Zivi">Andrea Zivi</name>
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<inist:fA14 i1="01">
<s1>Institute of Cancer Research and Royal Marsden Hospital</s1>
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<sZ>1 aut.</sZ>
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<name sortKey="Bianchini, Diletta" sort="Bianchini, Diletta" uniqKey="Bianchini D" first="Diletta" last="Bianchini">Diletta Bianchini</name>
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<inist:fA14 i1="01">
<s1>Institute of Cancer Research and Royal Marsden Hospital</s1>
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<s3>GBR</s3>
<sZ>1 aut.</sZ>
<sZ>26 aut.</sZ>
<sZ>27 aut.</sZ>
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<name sortKey="Loriot, Yohann" sort="Loriot, Yohann" uniqKey="Loriot Y" first="Yohann" last="Loriot">Yohann Loriot</name>
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<inist:fA14 i1="06">
<s1>Institut Gustave Roussy</s1>
<s2>Villejuif</s2>
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<sZ>4 aut.</sZ>
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</inist:fA14>
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<name sortKey="Chieffo, Nicole" sort="Chieffo, Nicole" uniqKey="Chieffo N" first="Nicole" last="Chieffo">Nicole Chieffo</name>
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<inist:fA14 i1="05">
<s1>Ortho Biotech Oncology Research and Development</s1>
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<name sortKey="Kheoh, Thian" sort="Kheoh, Thian" uniqKey="Kheoh T" first="Thian" last="Kheoh">Thian Kheoh</name>
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<s1>Ortho Biotech Oncology Research and Development</s1>
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<name sortKey="Haqq, Christopher M" sort="Haqq, Christopher M" uniqKey="Haqq C" first="Christopher M." last="Haqq">Christopher M. Haqq</name>
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<s1>Ortho Biotech Oncology Research and Development</s1>
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<sZ>30 aut.</sZ>
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<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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<s1>Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College</s1>
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<title level="j" type="main">The New England journal of medicine</title>
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<title level="j" type="main">The New England journal of medicine</title>
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<term>Abiraterone</term>
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<term>Prostate cancer</term>
<term>Survival</term>
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<term>Abiratérone</term>
<term>Survie</term>
<term>Métastase</term>
<term>Cancer de la prostate</term>
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</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>
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<s1>HAQQ (Christopher M.)</s1>
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<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>
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<s1>Institute of Cancer Sciences, Glasgow , Cardiff University</s1>
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<sZ>8 aut.</sZ>
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<s1>Velindre Hospital</s1>
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<s3>GBR</s3>
<sZ>11 aut.</sZ>
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<fA14 i1="04">
<s1>Anderson Cancer Center</s1>
<s2>Houston</s2>
<s3>USA</s3>
<sZ>2 aut.</sZ>
<sZ>25 aut.</sZ>
</fA14>
<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>
</fA14>
<fA14 i1="06">
<s1>Institut Gustave Roussy</s1>
<s2>Villejuif</s2>
<s3>FRA</s3>
<sZ>4 aut.</sZ>
<sZ>28 aut.</sZ>
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<fA14 i1="07">
<s1>Centre Léon Bérard</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>22 aut.</sZ>
</fA14>
<fA14 i1="08">
<s1>Cross Cancer Institute</s1>
<s2>Edmonton, AB</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
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<fA14 i1="09">
<s1>BC Cancer Agency, Vancouver Cancer Centre</s1>
<s2>Vancouver</s2>
<s3>USA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="10">
<s1>University of Calgary</s1>
<s2>Calgary, AB</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
</fA14>
<fA14 i1="11">
<s1>BC Cancer Agency, Centre for the Southern Interior</s1>
<s2>Kelowna</s2>
<s3>CAN</s3>
<sZ>21 aut.</sZ>
</fA14>
<fA14 i1="12">
<s1>Oncology Hematology Consultants</s1>
<s2>Sarasota, FL</s2>
<s3>USA</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="13">
<s1>Nevada Cancer Institute</s1>
<s2>Las Vegas</s2>
<s3>USA</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA14 i1="14">
<s1>University of Montreal</s1>
<s2>Montreal</s2>
<s3>CAN</s3>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="15">
<s1>Haematology and Oncology Clinics of Australasia</s1>
<s2>Milton</s2>
<s3>AUS</s3>
<sZ>12 aut.</sZ>
</fA14>
<fA14 i1="16">
<s1>UCL Cancer Institute</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="17">
<s1>University of Colorado Cancer Center</s1>
<s2>Aurora</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
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<s1>Texas Oncology-Baylor Charles A. Sammons Cancer Center</s1>
<s2>Dallas</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
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<fA14 i1="19">
<s1>Sarah Cannon Research Institute</s1>
<s2>Nashville</s2>
<s3>USA</s3>
<sZ>18 aut.</sZ>
</fA14>
<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>
</fA14>
<fA14 i1="21">
<s1>San Camillo and Forlanini Hospitals</s1>
<s2>Rome</s2>
<s3>ITA</s3>
<sZ>20 aut.</sZ>
</fA14>
<fA14 i1="22">
<s1>Georgia Cancer Specialists</s1>
<s2>Atlanta</s2>
<s3>USA</s3>
<sZ>23 aut.</sZ>
</fA14>
<fA14 i1="23">
<s1>Prostate Oncology Specialists</s1>
<s2>Marina del Rey, CA</s2>
<s3>USA</s3>
<sZ>24 aut.</sZ>
</fA14>
<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>
</fA14>
<fA17 i1="01" i2="1">
<s1>COU-AA-301 Investigators</s1>
<s3>INC</s3>
</fA17>
<fA20>
<s1>1995-2005</s1>
</fA20>
<fA21>
<s1>2011</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>6013</s2>
<s5>354000192119870040</s5>
</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2011 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>46 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>11-0256944</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>The New England journal of medicine</s0>
</fA64>
<fA66 i1="01">
<s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>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.).</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B01</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B14D02</s0>
</fC02>
<fC02 i1="03" i2="X">
<s0>002B20B02</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Abiratérone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Abiraterone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Abiraterona</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Survie</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Survival</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Sobrevivencia</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Métastase</s0>
<s5>03</s5>
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<fC03 i1="03" i2="X" l="ENG">
<s0>Metastasis</s0>
<s5>03</s5>
</fC03>
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<s0>Metástasis</s0>
<s5>03</s5>
</fC03>
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<s0>Cancer de la prostate</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Prostate cancer</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Cáncer de la próstata</s0>
<s2>NM</s2>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Stade avancé</s0>
<s5>05</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Advanced stage</s0>
<s5>05</s5>
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<s0>Estadio avanzado</s0>
<s5>05</s5>
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<s0>Métastatique</s0>
<s5>06</s5>
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<s5>06</s5>
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<s5>06</s5>
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<s5>08</s5>
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<s5>08</s5>
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<s0>Medicina</s0>
<s5>08</s5>
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<s0>Antiandrogène</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Antiandrogen</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Antiandrógeno</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Antihormone</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Antihormone</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Antihormona</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Tumeur maligne</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Malignant tumor</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Tumor maligno</s0>
<s2>NM</s2>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Cancer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Cáncer</s0>
<s2>NM</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Pathologie de l'appareil génital mâle</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Male genital diseases</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Aparato genital macho patología</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Pathologie de l'appareil urinaire</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Urinary system disease</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Aparato urinario patología</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE">
<s0>Pathologie de la prostate</s0>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG">
<s0>Prostate disease</s0>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA">
<s0>Prostata patología</s0>
<s5>42</s5>
</fC07>
<fN21>
<s1>171</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
<server>
<NO>PASCAL 11-0256944 INIST</NO>
<ET>Abiraterone and Increased Survival in Metastatic Prostate Cancer</ET>
<AU>DE BONO (Johann S.); LOGOTHETIS (Christopher J.); MOLINA (Arturo); FIZAZI (Karim); NORTH (Scott); CHU (Luis); CHI (Kim N.); JONES (RobertJ.); GOODMAN (Oscar B. JR); SAAD (Fred); STAFFURTH (John N.); MAINWARING (Paul); HARLAND (Stephen); FLAIG (Thomas W.); HUTSON (Thomas E.); CHENG (Tina); PATTERSON (Helen); HAINSWORTH (John D.); RYAN (CharlesJ.); STERNBERG (Cora N.); ELLARD (Susan L.); FLECHON (Aude); SALEH (Mansoor); SCHOLZ (Mark); EFSTATHIOU (Eleni); ZIVI (Andrea); BIANCHINI (Diletta); LORIOT (Yohann); CHIEFFO (Nicole); KHEOH (Thian); HAQQ (Christopher M.); SCHER (Howard I.)</AU>
<AF>Institute of Cancer Research and Royal Marsden Hospital/Sutton/Royaume-Uni (1 aut., 26 aut., 27 aut.); Institute of Cancer Sciences, Glasgow , Cardiff University/Royaume-Uni (8 aut.); Velindre Hospital/Cardiff/Royaume-Uni (11 aut.); Anderson Cancer Center/Houston/Etats-Unis (2 aut., 25 aut.); Ortho Biotech Oncology Research and Development/Los Angeles/Etats-Unis (3 aut., 29 aut., 30 aut., 31 aut.); Institut Gustave Roussy/Villejuif/France (4 aut., 28 aut.); Centre Léon Bérard/Lyon/France (22 aut.); Cross Cancer Institute/Edmonton, AB/Etats-Unis (5 aut.); BC Cancer Agency, Vancouver Cancer Centre/Vancouver/Etats-Unis (7 aut.); University of Calgary/Calgary, AB/Etats-Unis (16 aut.); BC Cancer Agency, Centre for the Southern Interior/Kelowna/Canada (21 aut.); Oncology Hematology Consultants/Sarasota, FL/Etats-Unis (6 aut.); Nevada Cancer Institute/Las Vegas/Etats-Unis (9 aut.); University of Montreal/Montreal/Canada (10 aut.); Haematology and Oncology Clinics of Australasia/Milton/Australie (12 aut.); UCL Cancer Institute/London/Royaume-Uni (13 aut.); University of Colorado Cancer Center/Aurora/Etats-Unis (14 aut.); Texas Oncology-Baylor Charles A. Sammons Cancer Center/Dallas/Etats-Unis (15 aut.); Sarah Cannon Research Institute/Nashville/Etats-Unis (18 aut.); Helen Diller Family Comprehensive Cancer Center, University of California-San Francisco/San Francisco/Etats-Unis (19 aut.); San Camillo and Forlanini Hospitals/Rome/Italie (20 aut.); Georgia Cancer Specialists/Atlanta/Etats-Unis (23 aut.); Prostate Oncology Specialists/Marina del Rey, CA/Etats-Unis (24 aut.); Memorial Sloan-Kettering Cancer Center, and Weill Cornell Medical College/New York/Etats-Unis (32 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>The New England journal of medicine; ISSN 0028-4793; Coden NEJMAG; Etats-Unis; Da. 2011; Vol. 364; No. 21; Pp. 1995-2005; Bibl. 46 ref.</SO>
<LA>Anglais</LA>
<EA>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.).</EA>
<CC>002B01; 002B14D02; 002B20B02</CC>
<FD>Abiratérone; Survie; Métastase; Cancer de la prostate; Stade avancé; Métastatique; Médecine</FD>
<FG>Antiandrogène; Antihormone; Tumeur maligne; Cancer; Pathologie de l'appareil génital mâle; Pathologie de l'appareil urinaire; Pathologie de la prostate</FG>
<ED>Abiraterone; Survival; Metastasis; Prostate cancer; Advanced stage; Metastatic; Medicine</ED>
<EG>Antiandrogen; Antihormone; Malignant tumor; Cancer; Male genital diseases; Urinary system disease; Prostate disease</EG>
<SD>Abiraterona; Sobrevivencia; Metástasis; Cáncer de la próstata; Estadio avanzado; Metastásico; Medicina</SD>
<LO>INIST-6013.354000192119870040</LO>
<ID>11-0256944</ID>
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