Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

2.50
Hdl Handle:
http://hdl.handle.net/2436/620919
Title:
Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy
Authors:
James, Nicholas D.; de Bono, Johann S.; Spears, Melissa R.; Clarke, Noel W.; Mason, Malcolm D.; Dearnaley, David P.; Ritchie, Alastair W.S.; Amos, Claire L.; Gilson, Clare; Jones, Rob J.; Matheson, David ( 0000-0002-3695-3167 ) ; Millman, Robin; Attard, Gerhardt; Chowdhury, Simon; Cross, William R.; Gillessen, Silke; Parker, Christopher C.; Russell, J. Martin; Berthold, Dominik R.; Brawley, Chris; Adab, Fawzi; Aung, San; Birtle, Alison J.; Bowen, Jo; Brock, Susannah; Chakraborti, Prabir; Ferguson, Catherine; Gale, Joanna; Gray, Emma; Hingorani, Mohan; Hoskin, Peter J.; Lester, Jason F.; Malik, Zafar I.; McKinna, Fiona; McPhail, Neil; Money-Kyrle, Julian; O’Sullivan, Joe; Parikh, Omi; Protheroe, Andrew; Robinson, Angus; Srihari, Narayanan N.; Thomas, Carys; Wagstaff, John; Wylie, James; Zarkar, Anjali; Parmar, Mahesh K.B.; Sydes, Matthew R.
Abstract:
BACKGROUND Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design. METHODS We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer). RESULTS A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease. Grade 3 to 5 adverse events occurred in 47% of the patients in the combination group (with nine grade 5 events) and in 33% of the patients in the ADT-alone group (with three grade 5 events). CONCLUSIONS Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than ADT alone. (Funded by Cancer Research U.K. and others; STAMPEDE ClinicalTrials.gov number, NCT00268476, and Current Controlled Trials number, ISRCTN78818544.)
Citation:
Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy 2017, 377 (4):338 New England Journal of Medicine
Publisher:
Massachusetts Medical Society
Journal:
New England Journal of Medicine, volume 377 issue 4 on pages 338 to 351
Issue Date:
27-Jul-2017
URI:
http://hdl.handle.net/2436/620919
DOI:
10.1056/NEJMoa1702900
Additional Links:
http://www.nejm.org/doi/10.1056/NEJMoa1702900
Type:
Article
Language:
en
ISSN:
0028-4793
Sponsors:
The Medical Research Council sponsored the study and was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript. Funding was also provided by Cancer Research UK, Astellas, Janssen, Novartis, Sanofi-Aventis, and Pfizer, none of which were directly involved in the research
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Full metadata record

DC FieldValue Language
dc.contributor.authorJames, Nicholas D.en
dc.contributor.authorde Bono, Johann S.en
dc.contributor.authorSpears, Melissa R.en
dc.contributor.authorClarke, Noel W.en
dc.contributor.authorMason, Malcolm D.en
dc.contributor.authorDearnaley, David P.en
dc.contributor.authorRitchie, Alastair W.S.en
dc.contributor.authorAmos, Claire L.en
dc.contributor.authorGilson, Clareen
dc.contributor.authorJones, Rob J.en
dc.contributor.authorMatheson, Daviden
dc.contributor.authorMillman, Robinen
dc.contributor.authorAttard, Gerhardten
dc.contributor.authorChowdhury, Simonen
dc.contributor.authorCross, William R.en
dc.contributor.authorGillessen, Silkeen
dc.contributor.authorParker, Christopher C.en
dc.contributor.authorRussell, J. Martinen
dc.contributor.authorBerthold, Dominik R.en
dc.contributor.authorBrawley, Chrisen
dc.contributor.authorAdab, Fawzien
dc.contributor.authorAung, Sanen
dc.contributor.authorBirtle, Alison J.en
dc.contributor.authorBowen, Joen
dc.contributor.authorBrock, Susannahen
dc.contributor.authorChakraborti, Prabiren
dc.contributor.authorFerguson, Catherineen
dc.contributor.authorGale, Joannaen
dc.contributor.authorGray, Emmaen
dc.contributor.authorHingorani, Mohanen
dc.contributor.authorHoskin, Peter J.en
dc.contributor.authorLester, Jason F.en
dc.contributor.authorMalik, Zafar I.en
dc.contributor.authorMcKinna, Fionaen
dc.contributor.authorMcPhail, Neilen
dc.contributor.authorMoney-Kyrle, Julianen
dc.contributor.authorO’Sullivan, Joeen
dc.contributor.authorParikh, Omien
dc.contributor.authorProtheroe, Andrewen
dc.contributor.authorRobinson, Angusen
dc.contributor.authorSrihari, Narayanan N.en
dc.contributor.authorThomas, Carysen
dc.contributor.authorWagstaff, Johnen
dc.contributor.authorWylie, Jamesen
dc.contributor.authorZarkar, Anjalien
dc.contributor.authorParmar, Mahesh K.B.en
dc.contributor.authorSydes, Matthew R.en
dc.date.accessioned2017-11-29T10:37:09Z-
dc.date.available2017-11-29T10:37:09Z-
dc.date.issued2017-07-27-
dc.identifier.citationAbiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy 2017, 377 (4):338 New England Journal of Medicineen
dc.identifier.issn0028-4793en
dc.identifier.doi10.1056/NEJMoa1702900-
dc.identifier.urihttp://hdl.handle.net/2436/620919-
dc.description.abstractBACKGROUND Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design. METHODS We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer). RESULTS A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease. Grade 3 to 5 adverse events occurred in 47% of the patients in the combination group (with nine grade 5 events) and in 33% of the patients in the ADT-alone group (with three grade 5 events). CONCLUSIONS Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than ADT alone. (Funded by Cancer Research U.K. and others; STAMPEDE ClinicalTrials.gov number, NCT00268476, and Current Controlled Trials number, ISRCTN78818544.)en
dc.description.sponsorshipThe Medical Research Council sponsored the study and was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript. Funding was also provided by Cancer Research UK, Astellas, Janssen, Novartis, Sanofi-Aventis, and Pfizer, none of which were directly involved in the researchen
dc.language.isoenen
dc.publisherMassachusetts Medical Societyen
dc.relation.urlhttp://www.nejm.org/doi/10.1056/NEJMoa1702900en
dc.rightsArchived with thanks to New England Journal of Medicineen
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectprostate canceren
dc.subjectabirateroneen
dc.subjecthormone-deprivation therapyen
dc.titleAbiraterone for Prostate Cancer Not Previously Treated with Hormone Therapyen
dc.typeArticleen
dc.identifier.journalNew England Journal of Medicine, volume 377 issue 4 on pages 338 to 351en
dc.date.accepted2017-05-
rioxxterms.funderThe Medical Research Council sponsored the study and was involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript. Funding was also provided by Cancer Research UK, Astellas, Janssen, Novartis, Sanofi-Aventis, and Pfizer, none of which were directly involved in the researchen
rioxxterms.identifier.projectUoW291117DMen
rioxxterms.versionVoRen
rioxxterms.licenseref.urihttps://creativecommons.org/CC BY-NC-ND 4.0en
rioxxterms.licenseref.startdate2018-02-01en
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