Hoyle AP 1 1 The Christie and Royal Salford Hospitals, Manchester, UK; Genito Urinary Cancer Research Group and the FASTMAN Centre of Excellence, Division of Cancer Sciences, The University of Manchester, Manchester, UK , Ali A 2 2 The Christie and Royal Salford Hospitals, Manchester, UK , James ND 3 3 Institute of Cancer and Genomic Sciences, University of Birmingham, Edgbaston, Birmingham, UK , Cook A 4 4 MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK , Parker CC 5 5 Royal Marsden Hospital, Sutton, UK , de Bono JS 5 5 Royal Marsden Hospital, Sutton, UK , et al.
COMMENT
Two randomised trials has established the use of Abiraterone (AA) as an alternative standard of care to Docetaxel treatment in men with metastatic Hormone Naïve Prostate Cancer (mHNPC) with “high risk” or high volume disease (11. Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017;377:352-60., 22. James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, et al. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017;377:338-51.). Uncertainty exists in the benefit of AA in “low risk” M1 disease.
This trail uses the STAMPEDE platform (33. Royston P, Barthel FM, Parmar MK, Choodari-Oskooei B, Isham V. Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit. Trials. 2011;12:81.) design, randomizing 1:1 for use of AA + androgen deprivation therapy (ADT) vs ADT alone.
There were a 34% survival benefit in the AA group also in the “low risk” mHNPC although the number needed to treat to prevent one death was 4 times higher in “low risk” group compared with the “high risk”.
This trial results support the use of abiraterone in mHNPC irrespective of “risk” or “volume.
REFERENCES
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1Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, et al. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017;377:352-60.
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2James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, et al. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017;377:338-51.
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3Royston P, Barthel FM, Parmar MK, Choodari-Oskooei B, Isham V. Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit. Trials. 2011;12:81.
Publication Dates
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Publication in this collection
18 Nov 2020 -
Date of issue
Jan-Feb 2021
