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Abiraterone for prostate cancer not previously treated with hormone therapy

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.
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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
 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.
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Other contributors
Affiliation
Epub Date
Issue Date
2017-06-03
Submitted date
Subjects
prostate cancer
 abiraterone
 hormone-deprivation therapy
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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
James, N., de Bono, J., Spears, M., Clarke, N. W., Mason, M., Dearnaley, D., Ritchie, A., Amos, C., Gilson, C., Jones, R., Matheson, D. J., Millman, R., Attard, G., Chowdhury, S., Cross, W., Gillessen, S., Parker, C., Russell, M., Berthold, D., Brawley, C., Adab, F., Aung, S., Birtle, A. J., Bowen, J., Brock, S., Chakraborti, P., Ferguson, C., Gale, J., Gray, E, Hingorani, M., Hoskin, P., Lester, J., Malik, Z., McKinna, F., McPhail, N., Money-Kyrle, J., O'Sullivan, J., Parikh, O., Protheroe, A., Robinson, A.., Srihari, N., Thomas, C., Wagstaff, J., Wylie, J., Zarkar, A., Parmar, M. and Sydes, M. (2017) Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. The New England journal of medicine, 377 (4). pp. 338-351.
Publisher
Massachusetts Medical Society
Journal
New England Journal of Medicine
Research Unit
URI
http://hdl.handle.net/2436/620919
DOI
10.1056/NEJMoa1702900
PubMed ID
PubMed Central ID
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http://www.nejm.org/doi/10.1056/NEJMoa1702900
Type
Journal article
Language
en
Description
© 2017 The Authors. Published by Massachusetts Medical Society. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher’s website: https://doi.org/10.1056/NEJMoa1702900
Series/Report no.
ISSN
0028-4793
EISSN
ISBN
ISMN
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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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