schliessen

Filtern

 

Bibliotheken

Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study

Summary Background Abiraterone acetate improved overall survival in metastatic castration-resistant prostate cancer at a preplanned interim analysis of the COU-AA-301 double-blind, placebo-controlled phase 3 study. Here, we present the final analysis of the study before crossover from placebo to abi... Full description

Journal Title: The lancet oncology 2012, Vol.13 (10), p.983-992
Main Author: Fizazi, Karim, Prof Dr
Other Authors: Scher, Howard I, Prof , Molina, Arturo, MD , Logothetis, Christopher J, Prof , Chi, Kim N, MD , Jones, Robert J, PhD , Staffurth, John N, MD , North, Scott, MD , Vogelzang, Nicholas J, MD , Saad, Fred, Prof , Mainwaring, Paul, MD , Harland, Stephen, MD , Goodman, Oscar B, MD , Sternberg, Cora N, MD , Li, Jin Hui, PhD , Kheoh, Thian, PhD , Haqq, Christopher M, MD , de Bono, Johann S, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
Link: https://www.ncbi.nlm.nih.gov/pubmed/22995653
Zum Text:
SendSend as email Add to Book BagAdd to Book Bag
Staff View
recordid: cdi_proquest_miscellaneous_1751215096
title: Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study
format: Article
creator:
  • Fizazi, Karim, Prof Dr
  • Scher, Howard I, Prof
  • Molina, Arturo, MD
  • Logothetis, Christopher J, Prof
  • Chi, Kim N, MD
  • Jones, Robert J, PhD
  • Staffurth, John N, MD
  • North, Scott, MD
  • Vogelzang, Nicholas J, MD
  • Saad, Fred, Prof
  • Mainwaring, Paul, MD
  • Harland, Stephen, MD
  • Goodman, Oscar B, MD
  • Sternberg, Cora N, MD
  • Li, Jin Hui, PhD
  • Kheoh, Thian, PhD
  • Haqq, Christopher M, MD
  • de Bono, Johann S, Prof
subjects:
  • Abiraterone Acetate
  • Adult
  • Aged
  • Aged, 80 and over
  • Androstadienes - therapeutic use
  • Cancer
  • Care and treatment
  • Castration
  • Double-Blind Method
  • Hematology, Oncology and Palliative Medicine
  • Humans
  • Male
  • Metastasis
  • Middle Aged
  • Neoplasm Metastasis
  • Oncology, Experimental
  • Orchiectomy
  • Patient outcomes
  • Prostate cancer
  • Prostatic Neoplasms - drug therapy
  • Prostatic Neoplasms - mortality
  • Prostatic Neoplasms - pathology
ispartof: The lancet oncology, 2012, Vol.13 (10), p.983-992
description: Summary Background Abiraterone acetate improved overall survival in metastatic castration-resistant prostate cancer at a preplanned interim analysis of the COU-AA-301 double-blind, placebo-controlled phase 3 study. Here, we present the final analysis of the study before crossover from placebo to abiraterone acetate (after 775 of the prespecified 797 death events). Methods Between May 8, 2008, and July 28, 2009, this study enrolled 1195 patients at 147 sites in 13 countries. Patients were eligible if they had metastatic castration-resistant prostate cancer progressing after docetaxel. Patients were stratified according to baseline Eastern Cooperative Oncology Group (ECOG) performance status, worst pain over the past 24 h on the Brief Pain Inventory-Short Form, number of previous chemotherapy regimens, and type of progression. Patients were randomly assigned (ratio 2:1) to receive either abiraterone acetate (1000 mg, once daily and orally) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone with a permuted block method via an interactive web response system. The primary endpoint was overall survival, analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov , number NCT00638690. Findings Of the 1195 eligible patients, 797 were randomly assigned to receive abiraterone acetate plus prednisone (abiraterone group) and 398 to receive placebo plus prednisone (placebo group). At median follow-up of 20·2 months (IQR 18·4–22·1), median overall survival for the abiraterone group was longer than in the placebo group (15·8 months [95% CI 14·8–17·0] vs 11·2 months [10·4–13·1]; hazard ratio [HR] 0·74, 95% CI 0·64–0·86; p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
url: Link


@attributes
NO1
SEARCH_ENGINEprimo_central_multiple_fe
SEARCH_ENGINE_TYPEPrimo Central Search Engine
RANK2.810156
LOCALfalse
PrimoNMBib
record
control
sourceidgale_proqu
recordidTN_cdi_proquest_miscellaneous_1751215096
sourceformatXML
sourcesystemPC
galeidA303790929
sourcerecordidA303790929
originalsourceidFETCH-LOGICAL-1680t-c0da6f6082ec6feb46b763257f0aff97b0ccdd969bac9388f763626067e6839f3
addsrcrecordideNqNUl1v1DAQjBCIlsJPAFnipUikrJ2Lk4AEOp34kir1AfpsOc6auvjiw05Our_HL2NzV1pxomqVh6zXM-Oxd7LsOYcTDly--cZnFeQCZuUxF68qKKomhwfZIbVneTmr64fbegc5yJ6kdAnAKw7l4-xAiKYpZVkcZr_nrYt6wBh6ZNrgQDWzIbIhoh6W2A8sWLakfqItZ5ihgggu9HnE5KhLkFUMacs0ujcY3zLreu1ZWGPU3rM0xrVbU0NTd0OkSXO4QLY4O8_n87wAzqLuu7B0CbvXrAtj6zFvvetptfLkqw25Cf0Qg_fYsdWFTsgKloax2zzNHlntEz67-h9l558-fl98yU_PPn9dzE9zLmsYcgOdllZCLdBIi-1MtpUsRFlZ0NY2VQvGdF0jm1abpqhrS7tSSJAVyrpobHGUHe906ba_RkyDIrsGvdc9hjEpXpVc8BIaeT8o8LJu7oYKwfmMxlsT9OUe9DKMkZ6UUHStAgAauEH90B6V622geZlJVM2LKSbQiOnYk_-g6Otw6eil0Trq_0ModwRDs04RrVpFt9RxQ2erKZFqm0g1xY1Mq20i1WTnxZXpsV1id836G0ECvNsTNm7YBowcOX8tn26Rvx_7NnMfdmyk3KwdRpWMQ4pw5yKaQXXB3anwfk_BUGqd0f4nbjDdDEgloWAnMmlwsVWA4g8KAioy
sourcetypeAggregation Database
isCDItrue
recordtypearticle
pqid1082300090
display
typearticle
titleAbiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study
sourceAlma/SFX Local Collection
creatorFizazi, Karim, Prof Dr ; Scher, Howard I, Prof ; Molina, Arturo, MD ; Logothetis, Christopher J, Prof ; Chi, Kim N, MD ; Jones, Robert J, PhD ; Staffurth, John N, MD ; North, Scott, MD ; Vogelzang, Nicholas J, MD ; Saad, Fred, Prof ; Mainwaring, Paul, MD ; Harland, Stephen, MD ; Goodman, Oscar B, MD ; Sternberg, Cora N, MD ; Li, Jin Hui, PhD ; Kheoh, Thian, PhD ; Haqq, Christopher M, MD ; de Bono, Johann S, Prof
creatorcontribFizazi, Karim, Prof Dr ; Scher, Howard I, Prof ; Molina, Arturo, MD ; Logothetis, Christopher J, Prof ; Chi, Kim N, MD ; Jones, Robert J, PhD ; Staffurth, John N, MD ; North, Scott, MD ; Vogelzang, Nicholas J, MD ; Saad, Fred, Prof ; Mainwaring, Paul, MD ; Harland, Stephen, MD ; Goodman, Oscar B, MD ; Sternberg, Cora N, MD ; Li, Jin Hui, PhD ; Kheoh, Thian, PhD ; Haqq, Christopher M, MD ; de Bono, Johann S, Prof ; for the COU-AA-301 Investigators ; COU-AA-301 Investigators
descriptionSummary Background Abiraterone acetate improved overall survival in metastatic castration-resistant prostate cancer at a preplanned interim analysis of the COU-AA-301 double-blind, placebo-controlled phase 3 study. Here, we present the final analysis of the study before crossover from placebo to abiraterone acetate (after 775 of the prespecified 797 death events). Methods Between May 8, 2008, and July 28, 2009, this study enrolled 1195 patients at 147 sites in 13 countries. Patients were eligible if they had metastatic castration-resistant prostate cancer progressing after docetaxel. Patients were stratified according to baseline Eastern Cooperative Oncology Group (ECOG) performance status, worst pain over the past 24 h on the Brief Pain Inventory-Short Form, number of previous chemotherapy regimens, and type of progression. Patients were randomly assigned (ratio 2:1) to receive either abiraterone acetate (1000 mg, once daily and orally) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone with a permuted block method via an interactive web response system. The primary endpoint was overall survival, analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov , number NCT00638690. Findings Of the 1195 eligible patients, 797 were randomly assigned to receive abiraterone acetate plus prednisone (abiraterone group) and 398 to receive placebo plus prednisone (placebo group). At median follow-up of 20·2 months (IQR 18·4–22·1), median overall survival for the abiraterone group was longer than in the placebo group (15·8 months [95% CI 14·8–17·0] vs 11·2 months [10·4–13·1]; hazard ratio [HR] 0·74, 95% CI 0·64–0·86; p<0·0001). Median time to PSA progression (8·5 months, 95% CI 8·3–11·1, in the abiraterone group vs 6·6 months, 5·6–8·3, in the placebo group; HR 0·63, 0·52–0·78; p<0·0001), median radiologic progression-free survival (5·6 months, 5·6–6·5, vs 3·6 months, 2·9–5·5; HR 0·66, 0·58–0·76; p<0·0001), and proportion of patients who had a PSA response (235 [29·5%] of 797 patients vs 22 [5·5%] of 398; p<0·0001) were all improved in the abiraterone group compared with the placebo group. The most common grade 3–4 adverse events were fatigue (72 [9%] of 791 patients in the abiraterone group vs 41 [10%] of 394 in the placebo group), anaemia (62 [8%] vs 32 [8%]), back pain (56 [7%] vs 40 [10%]), and bone pain (51 [6%] vs 31 [8%]). Interpretation This final analysis confirms that abiraterone acetate significantly prolongs overall survival in patients with metastatic castration-resistant prostate cancer who have progressed after docetaxel treatment. No new safety signals were identified with increased follow-up. Funding Janssen Research & Development.
identifier
0ISSN: 1470-2045
1EISSN: 1474-5488
2DOI: 10.1016/S1470-2045(12)70379-0
3PMID: 22995653
4CODEN: LANCAO
languageeng
publisherEngland: Elsevier Ltd
subjectAbiraterone Acetate ; Adult ; Aged ; Aged, 80 and over ; Androstadienes - therapeutic use ; Cancer ; Care and treatment ; Castration ; Double-Blind Method ; Hematology, Oncology and Palliative Medicine ; Humans ; Male ; Metastasis ; Middle Aged ; Neoplasm Metastasis ; Oncology, Experimental ; Orchiectomy ; Patient outcomes ; Prostate cancer ; Prostatic Neoplasms - drug therapy ; Prostatic Neoplasms - mortality ; Prostatic Neoplasms - pathology
ispartofThe lancet oncology, 2012, Vol.13 (10), p.983-992
rights
0Elsevier Ltd
12012 Elsevier Ltd
2Copyright © 2012 Elsevier Ltd. All rights reserved.
3COPYRIGHT 2012 Elsevier B.V.
lds50peer_reviewed
oafree_for_read
citedbyFETCH-LOGICAL-1680t-c0da6f6082ec6feb46b763257f0aff97b0ccdd969bac9388f763626067e6839f3
citesFETCH-LOGICAL-1680t-c0da6f6082ec6feb46b763257f0aff97b0ccdd969bac9388f763626067e6839f3
links
openurl$$Topenurl_article
openurlfulltext$$Topenurlfull_article
thumbnail$$Usyndetics_thumb_exl
backlink$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22995653$$D View this record in MEDLINE/PubMed
search
creatorcontrib
0Fizazi, Karim, Prof Dr
1Scher, Howard I, Prof
2Molina, Arturo, MD
3Logothetis, Christopher J, Prof
4Chi, Kim N, MD
5Jones, Robert J, PhD
6Staffurth, John N, MD
7North, Scott, MD
8Vogelzang, Nicholas J, MD
9Saad, Fred, Prof
10Mainwaring, Paul, MD
11Harland, Stephen, MD
12Goodman, Oscar B, MD
13Sternberg, Cora N, MD
14Li, Jin Hui, PhD
15Kheoh, Thian, PhD
16Haqq, Christopher M, MD
17de Bono, Johann S, Prof
18for the COU-AA-301 Investigators
19COU-AA-301 Investigators
title
0Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study
1The lancet oncology
addtitleLancet Oncol
descriptionSummary Background Abiraterone acetate improved overall survival in metastatic castration-resistant prostate cancer at a preplanned interim analysis of the COU-AA-301 double-blind, placebo-controlled phase 3 study. Here, we present the final analysis of the study before crossover from placebo to abiraterone acetate (after 775 of the prespecified 797 death events). Methods Between May 8, 2008, and July 28, 2009, this study enrolled 1195 patients at 147 sites in 13 countries. Patients were eligible if they had metastatic castration-resistant prostate cancer progressing after docetaxel. Patients were stratified according to baseline Eastern Cooperative Oncology Group (ECOG) performance status, worst pain over the past 24 h on the Brief Pain Inventory-Short Form, number of previous chemotherapy regimens, and type of progression. Patients were randomly assigned (ratio 2:1) to receive either abiraterone acetate (1000 mg, once daily and orally) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone with a permuted block method via an interactive web response system. The primary endpoint was overall survival, analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov , number NCT00638690. Findings Of the 1195 eligible patients, 797 were randomly assigned to receive abiraterone acetate plus prednisone (abiraterone group) and 398 to receive placebo plus prednisone (placebo group). At median follow-up of 20·2 months (IQR 18·4–22·1), median overall survival for the abiraterone group was longer than in the placebo group (15·8 months [95% CI 14·8–17·0] vs 11·2 months [10·4–13·1]; hazard ratio [HR] 0·74, 95% CI 0·64–0·86; p<0·0001). Median time to PSA progression (8·5 months, 95% CI 8·3–11·1, in the abiraterone group vs 6·6 months, 5·6–8·3, in the placebo group; HR 0·63, 0·52–0·78; p<0·0001), median radiologic progression-free survival (5·6 months, 5·6–6·5, vs 3·6 months, 2·9–5·5; HR 0·66, 0·58–0·76; p<0·0001), and proportion of patients who had a PSA response (235 [29·5%] of 797 patients vs 22 [5·5%] of 398; p<0·0001) were all improved in the abiraterone group compared with the placebo group. The most common grade 3–4 adverse events were fatigue (72 [9%] of 791 patients in the abiraterone group vs 41 [10%] of 394 in the placebo group), anaemia (62 [8%] vs 32 [8%]), back pain (56 [7%] vs 40 [10%]), and bone pain (51 [6%] vs 31 [8%]). Interpretation This final analysis confirms that abiraterone acetate significantly prolongs overall survival in patients with metastatic castration-resistant prostate cancer who have progressed after docetaxel treatment. No new safety signals were identified with increased follow-up. Funding Janssen Research & Development.
subject
0Abiraterone Acetate
1Adult
2Aged
3Aged, 80 and over
4Androstadienes - therapeutic use
5Cancer
6Care and treatment
7Castration
8Double-Blind Method
9Hematology, Oncology and Palliative Medicine
10Humans
11Male
12Metastasis
13Middle Aged
14Neoplasm Metastasis
15Oncology, Experimental
16Orchiectomy
17Patient outcomes
18Prostate cancer
19Prostatic Neoplasms - drug therapy
20Prostatic Neoplasms - mortality
21Prostatic Neoplasms - pathology
issn
01470-2045
11474-5488
fulltexttrue
rsrctypearticle
creationdate2012
recordtypearticle
recordideNqNUl1v1DAQjBCIlsJPAFnipUikrJ2Lk4AEOp34kir1AfpsOc6auvjiw05Our_HL2NzV1pxomqVh6zXM-Oxd7LsOYcTDly--cZnFeQCZuUxF68qKKomhwfZIbVneTmr64fbegc5yJ6kdAnAKw7l4-xAiKYpZVkcZr_nrYt6wBh6ZNrgQDWzIbIhoh6W2A8sWLakfqItZ5ihgggu9HnE5KhLkFUMacs0ujcY3zLreu1ZWGPU3rM0xrVbU0NTd0OkSXO4QLY4O8_n87wAzqLuu7B0CbvXrAtj6zFvvetptfLkqw25Cf0Qg_fYsdWFTsgKloax2zzNHlntEz67-h9l558-fl98yU_PPn9dzE9zLmsYcgOdllZCLdBIi-1MtpUsRFlZ0NY2VQvGdF0jm1abpqhrS7tSSJAVyrpobHGUHe906ba_RkyDIrsGvdc9hjEpXpVc8BIaeT8o8LJu7oYKwfmMxlsT9OUe9DKMkZ6UUHStAgAauEH90B6V622geZlJVM2LKSbQiOnYk_-g6Otw6eil0Trq_0ModwRDs04RrVpFt9RxQ2erKZFqm0g1xY1Mq20i1WTnxZXpsV1id836G0ECvNsTNm7YBowcOX8tn26Rvx_7NnMfdmyk3KwdRpWMQ4pw5yKaQXXB3anwfk_BUGqd0f4nbjDdDEgloWAnMmlwsVWA4g8KAioy
startdate2012
enddate2012
creator
0Fizazi, Karim, Prof Dr
1Scher, Howard I, Prof
2Molina, Arturo, MD
3Logothetis, Christopher J, Prof
4Chi, Kim N, MD
5Jones, Robert J, PhD
6Staffurth, John N, MD
7North, Scott, MD
8Vogelzang, Nicholas J, MD
9Saad, Fred, Prof
10Mainwaring, Paul, MD
11Harland, Stephen, MD
12Goodman, Oscar B, MD
13Sternberg, Cora N, MD
14Li, Jin Hui, PhD
15Kheoh, Thian, PhD
16Haqq, Christopher M, MD
17de Bono, Johann S, Prof
general
0Elsevier Ltd
1Elsevier B.V
2Elsevier Limited
scope
0CGR
1CUY
2CVF
3ECM
4EIF
5NPM
6AAYXX
7CITATION
8BSHEE
90TZ
103V.
117RV
127TO
137X7
147XB
1588E
168AO
178C1
188C2
198FI
208FJ
218FK
22ABUWG
23BENPR
24FYUFA
25GHDGH
26H94
27K9.
28KB0
29M0S
30M1P
31NAPCQ
32PQEST
33PQQKQ
34PQUKI
35PRINS
367X8
sort
creationdate2012
titleAbiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study
authorFizazi, Karim, Prof Dr ; Scher, Howard I, Prof ; Molina, Arturo, MD ; Logothetis, Christopher J, Prof ; Chi, Kim N, MD ; Jones, Robert J, PhD ; Staffurth, John N, MD ; North, Scott, MD ; Vogelzang, Nicholas J, MD ; Saad, Fred, Prof ; Mainwaring, Paul, MD ; Harland, Stephen, MD ; Goodman, Oscar B, MD ; Sternberg, Cora N, MD ; Li, Jin Hui, PhD ; Kheoh, Thian, PhD ; Haqq, Christopher M, MD ; de Bono, Johann S, Prof
facets
frbrtype5
frbrgroupidcdi_FETCH-LOGICAL-1680t-c0da6f6082ec6feb46b763257f0aff97b0ccdd969bac9388f763626067e6839f3
rsrctypearticles
prefilterarticles
languageeng
creationdate2012
topic
0Abiraterone Acetate
1Adult
2Aged
3Aged, 80 and over
4Androstadienes - therapeutic use
5Cancer
6Care and treatment
7Castration
8Double-Blind Method
9Hematology, Oncology and Palliative Medicine
10Humans
11Male
12Metastasis
13Middle Aged
14Neoplasm Metastasis
15Oncology, Experimental
16Orchiectomy
17Patient outcomes
18Prostate cancer
19Prostatic Neoplasms - drug therapy
20Prostatic Neoplasms - mortality
21Prostatic Neoplasms - pathology
toplevel
0peer_reviewed
1online_resources
creatorcontrib
0Fizazi, Karim, Prof Dr
1Scher, Howard I, Prof
2Molina, Arturo, MD
3Logothetis, Christopher J, Prof
4Chi, Kim N, MD
5Jones, Robert J, PhD
6Staffurth, John N, MD
7North, Scott, MD
8Vogelzang, Nicholas J, MD
9Saad, Fred, Prof
10Mainwaring, Paul, MD
11Harland, Stephen, MD
12Goodman, Oscar B, MD
13Sternberg, Cora N, MD
14Li, Jin Hui, PhD
15Kheoh, Thian, PhD
16Haqq, Christopher M, MD
17de Bono, Johann S, Prof
18for the COU-AA-301 Investigators
19COU-AA-301 Investigators
collection
0Medline
1MEDLINE
2MEDLINE (Ovid)
3MEDLINE
4MEDLINE
5PubMed
6CrossRef
7Academic OneFile (A&I only)
8Pharma and Biotech Premium PRO
9ProQuest Central (Corporate)
10Nursing & Allied Health Database
11Oncogenes and Growth Factors Abstracts
12Health & Medical Collection
13ProQuest Central (purchase pre-March 2016)
14Medical Database (Alumni Edition)
15ProQuest Pharma Collection
16Public Health Database
17Lancet Titles
18Hospital Premium Collection
19Hospital Premium Collection (Alumni Edition)
20ProQuest Central (Alumni) (purchase pre-March 2016)
21ProQuest Central (Alumni Edition)
22ProQuest Central
23Health Research Premium Collection
24Health Research Premium Collection (Alumni)
25AIDS and Cancer Research Abstracts
26ProQuest Health & Medical Complete (Alumni)
27Nursing & Allied Health Database (Alumni Edition)
28Health & Medical Collection (Alumni Edition)
29Medical Database
30Nursing & Allied Health Premium
31ProQuest One Academic Eastern Edition
32ProQuest One Academic
33ProQuest One Academic UKI Edition
34ProQuest Central China
35MEDLINE - Academic
jtitleThe lancet oncology
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Fizazi, Karim, Prof Dr
1Scher, Howard I, Prof
2Molina, Arturo, MD
3Logothetis, Christopher J, Prof
4Chi, Kim N, MD
5Jones, Robert J, PhD
6Staffurth, John N, MD
7North, Scott, MD
8Vogelzang, Nicholas J, MD
9Saad, Fred, Prof
10Mainwaring, Paul, MD
11Harland, Stephen, MD
12Goodman, Oscar B, MD
13Sternberg, Cora N, MD
14Li, Jin Hui, PhD
15Kheoh, Thian, PhD
16Haqq, Christopher M, MD
17de Bono, Johann S, Prof
aucorp
0for the COU-AA-301 Investigators
1COU-AA-301 Investigators
formatjournal
genrearticle
ristypeJOUR
atitleAbiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study
jtitleThe lancet oncology
addtitleLancet Oncol
date2012
risdate2012
volume13
issue10
spage983
epage992
pages983-992
issn1470-2045
eissn1474-5488
codenLANCAO
abstractSummary Background Abiraterone acetate improved overall survival in metastatic castration-resistant prostate cancer at a preplanned interim analysis of the COU-AA-301 double-blind, placebo-controlled phase 3 study. Here, we present the final analysis of the study before crossover from placebo to abiraterone acetate (after 775 of the prespecified 797 death events). Methods Between May 8, 2008, and July 28, 2009, this study enrolled 1195 patients at 147 sites in 13 countries. Patients were eligible if they had metastatic castration-resistant prostate cancer progressing after docetaxel. Patients were stratified according to baseline Eastern Cooperative Oncology Group (ECOG) performance status, worst pain over the past 24 h on the Brief Pain Inventory-Short Form, number of previous chemotherapy regimens, and type of progression. Patients were randomly assigned (ratio 2:1) to receive either abiraterone acetate (1000 mg, once daily and orally) plus prednisone (5 mg, orally twice daily) or placebo plus prednisone with a permuted block method via an interactive web response system. The primary endpoint was overall survival, analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov , number NCT00638690. Findings Of the 1195 eligible patients, 797 were randomly assigned to receive abiraterone acetate plus prednisone (abiraterone group) and 398 to receive placebo plus prednisone (placebo group). At median follow-up of 20·2 months (IQR 18·4–22·1), median overall survival for the abiraterone group was longer than in the placebo group (15·8 months [95% CI 14·8–17·0] vs 11·2 months [10·4–13·1]; hazard ratio [HR] 0·74, 95% CI 0·64–0·86; p<0·0001). Median time to PSA progression (8·5 months, 95% CI 8·3–11·1, in the abiraterone group vs 6·6 months, 5·6–8·3, in the placebo group; HR 0·63, 0·52–0·78; p<0·0001), median radiologic progression-free survival (5·6 months, 5·6–6·5, vs 3·6 months, 2·9–5·5; HR 0·66, 0·58–0·76; p<0·0001), and proportion of patients who had a PSA response (235 [29·5%] of 797 patients vs 22 [5·5%] of 398; p<0·0001) were all improved in the abiraterone group compared with the placebo group. The most common grade 3–4 adverse events were fatigue (72 [9%] of 791 patients in the abiraterone group vs 41 [10%] of 394 in the placebo group), anaemia (62 [8%] vs 32 [8%]), back pain (56 [7%] vs 40 [10%]), and bone pain (51 [6%] vs 31 [8%]). Interpretation This final analysis confirms that abiraterone acetate significantly prolongs overall survival in patients with metastatic castration-resistant prostate cancer who have progressed after docetaxel treatment. No new safety signals were identified with increased follow-up. Funding Janssen Research & Development.
copEngland
pubElsevier Ltd
pmid22995653
doi10.1016/S1470-2045(12)70379-0
oafree_for_read