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    Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5-year follow-up results from the STAMPEDE randomised trial (NCT00268476)

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    Authors
    James, N. D.
    Clarke, Noel W
    Cook, A.
    Ali, Adnan
    Hoyle, A. P.
    Attard, G.
    Brawley, C. D.
    Chowdhury, S.
    Cross, W. R.
    Dearnaley, D. P.
    de Bono, J. S.
    Montana, C. D.
    Gilbert, D.
    Gillessen, S.
    Gilson, C.
    Jones, R. J.
    Langley, R. E.
    Malik, Z. I.
    Matheson, D. J.
    Millman, R.
    Parker, C. C.
    Pugh, C.
    Rush, H.
    Russell, J. M.
    Berthold, D. R.
    Buckner, M. L.
    Mason, M. D.
    Ritchie, A. W.
    Birtle, A. J.
    Brock, S. J.
    Das, P.
    Ford, D.
    Gale, J.
    Grant, W.
    Gray, E. K.
    Hoskin, P.
    Khan, M. M.
    Manetta, C.
    McPhail, N. J.
    O'Sullivan, J. M.
    Parikh, O.
    Perna, C.
    Pezaro, C. J.
    Protheroe, A. S.
    Robinson, A. J.
    Rudman, S. M.
    Sheehan, D. J.
    Srihari, N. N.
    Syndikus, I.
    Tanguay, J.
    Thomas, C. W.
    Vengalil, S.
    Wagstaff, J.
    Wylie, James P
    Parmar, M. K.
    Sydes, M. R.
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    Affiliation
    Institute of Cancer Research, London, UK
    Issue Date
    2022
    
    Metadata
    Show full item record
    Abstract
    Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multi-arm, multi-stage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis in metastatic patients was planned for 3 yrs after the first results. Standard-of-care (SOC) was androgen deprivation therapy. The comparison randomized patients 1:1 to SOC-alone with or without daily abiraterone acetate 1000 mg + prednisolone 5 mg (SOC + AAP), continued until disease progression. The primary outcome measure was overall survival. Metastatic disease risk group was classified retrospectively using baseline CT and bone scans by central radiological review and pathology reports. Analyses used Cox proportional hazards & flexible parametric models, adjusted for baseline stratification factors. 1003 patients were contemporaneously randomized (Nov-2011--Jan-2014): median age 67 yr; 94% newly-diagnosed; metastatic disease risk group: 48% high, 44% low, 8% un-assessable; median PSA 97 ng/mL. At 6.1 yr median follow-up, 329 SOC-alone deaths (118 low-risk, 178 high-risk) and 244 SOC + AAP deaths (75 low-risk, 145 high-risk) were reported. Adjusted HR = 0·60 (95%CI:0·50-0·71; P = 0.31x10-9 ) favoured SOC + AAP, with 5-yr survival improved from 41% SOC-alone to 60% SOC + AAP. This was similar in low-risk (HR = 0·55; 95%CI:0·41-0·76) and high-risk (HR = 0·54; 95%CI:0·43-0·69) patients. Median and current maximum time on SOC + AAP was 2.4 yr and 8.1 yr. Toxicity at 4 yr post-randomisation was similar, with 16% patients in each group reporting grade 3 or higher toxicity. A sustained and substantial improvement in overall survival of all metastatic prostate cancer patients was achieved with SOC + abiraterone acetate + prednisolone, irrespective of metastatic disease risk group.
    Citation
    James ND, Clarke NW, Cook A, Ali A, Hoyle AP, Attard G, et al. Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5‐year follow‐up results from the STAMPEDE randomised trial (NCT00268476). International Journal of Cancer. Wiley; 2022.
    Journal
    International Journal of Cancer
    URI
    http://hdl.handle.net/10541/625260
    DOI
    10.1002/ijc.34018
    PubMed ID
    35411939
    Additional Links
    https://dx.doi.org/10.1002/ijc.34018
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1002/ijc.34018
    Scopus Count
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