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    Docetaxel for nonmetastatic prostate cancer: long-term survival outcomes in the STAMPEDE randomized controlled trial

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    Authors
    James, N. D.
    Ingleby, F. C.
    Clarke, Noel W
    Amos, C.
    Attard, G.
    Brawley, C. D.
    Chowdhury, S.
    Cross, W.
    Dearnaley, D. P.
    Gilbert, D. C.
    Gillessen, S.
    Jones, R. J.
    Langley, R. E.
    Macnair, A.
    Malik, Z. I.
    Mason, M. D.
    Matheson, D. J.
    Millman, R.
    Parker, C. C.
    Rush, H. L.
    Russell, J. M.
    Au, C.
    Ritchie, A. W. S.
    Mestre, R. P.
    Ahmed, I.
    Birtle, A. J.
    Brock, S. J.
    Das, P.
    Ford, V. A.
    Gray, E. K.
    Hughes, R. J.
    Manetta, C. B.
    McLaren, D. B.
    Nikapota, A. D.
    O'Sullivan, J. M.
    Perna, C.
    Peedell, C.
    Protheroe, A. S.
    Sundar, S.
    Tanguay, J. S.
    Tolan, S. P.
    Wagstaff, J.
    Wallace, J. B.
    Wylie, James P
    Zarkar, A.
    Parmar, M. K. B.
    Sydes, M. R.
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    Affiliation
    The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, UK
    Issue Date
    2022
    
    Metadata
    Show full item record
    Abstract
    Background: STAMPEDE previously reported adding upfront docetaxel improved overall survival for prostate cancer patients starting long-term androgen deprivation therapy. We report long-term results for non-metastatic patients using, as primary outcome, metastatic progression-free survival (mPFS), an externally demonstrated surrogate for overall survival. Methods: Standard of care (SOC) was androgen deprivation therapy with or without radical prostate radiotherapy. A total of 460 SOC and 230 SOC plus docetaxel were randomly assigned 2:1. Standard survival methods and intention to treat were used. Treatment effect estimates were summarized from adjusted Cox regression models, switching to restricted mean survival time if non-proportional hazards. mPFS (new metastases, skeletal-related events, or prostate cancer death) had 70% power (α = 0.05) for a hazard ratio (HR) of 0.70. Secondary outcome measures included overall survival, failure-free survival (FFS), and progression-free survival (PFS: mPFS, locoregional progression). Results: Median follow-up was 6.5 years with 142 mPFS events on SOC (3 year and 54% increases over previous report). There was no good evidence of an advantage to SOC plus docetaxel on mPFS (HR = 0.89, 95% confidence interval [CI] = 0.66 to 1.19; P = .43); with 5-year mPFS 82% (95% CI = 78% to 87%) SOC plus docetaxel vs 77% (95% CI = 73% to 81%) SOC. Secondary outcomes showed evidence SOC plus docetaxel improved FFS (HR = 0.70, 95% CI = 0.55 to 0.88; P = .002) and PFS (nonproportional P = .03, restricted mean survival time difference = 5.8 months, 95% CI = 0.5 to 11.2; P = .03) but no good evidence of overall survival benefit (125 SOC deaths; HR = 0.88, 95% CI = 0.64 to 1.21; P = .44). There was no evidence SOC plus docetaxel increased late toxicity: post 1 year, 29% SOC and 30% SOC plus docetaxel grade 3-5 toxicity. Conclusions: There is robust evidence that SOC plus docetaxel improved FFS and PFS (previously shown to increase quality-adjusted life-years), without excess late toxicity, which did not translate into benefit for longer-term outcomes. This may influence patient management in individual cases.
    Citation
    James ND, Ingleby FC, Clarke NW, Amos C, Attard G, Brawley CD, et al. Docetaxel for nonmetastatic prostate cancer: long-term survival outcomes in the STAMPEDE randomized controlled trial. JNCI cancer spectrum. 2022 Jul 25;6(4). PubMed PMID: 35877084. Epub 2022/07/26. eng.
    Journal
    JNCI Cancer Spectrum
    URI
    http://hdl.handle.net/10541/625446
    DOI
    10.1093/jncics/pkac043
    PubMed ID
    35877084
    Additional Links
    https://dx.doi.org/10.1093/jncics/pkac043
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1093/jncics/pkac043
    Scopus Count
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