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dc.contributor.authorJames, N. D.
dc.contributor.authorIngleby, F. C.
dc.contributor.authorClarke, Noel W
dc.contributor.authorAmos, C.
dc.contributor.authorAttard, G.
dc.contributor.authorBrawley, C. D.
dc.contributor.authorChowdhury, S.
dc.contributor.authorCross, W.
dc.contributor.authorDearnaley, D. P.
dc.contributor.authorGilbert, D. C.
dc.contributor.authorGillessen, S.
dc.contributor.authorJones, R. J.
dc.contributor.authorLangley, R. E.
dc.contributor.authorMacnair, A.
dc.contributor.authorMalik, Z. I.
dc.contributor.authorMason, M. D.
dc.contributor.authorMatheson, D. J.
dc.contributor.authorMillman, R.
dc.contributor.authorParker, C. C.
dc.contributor.authorRush, H. L.
dc.contributor.authorRussell, J. M.
dc.contributor.authorAu, C.
dc.contributor.authorRitchie, A. W. S.
dc.contributor.authorMestre, R. P.
dc.contributor.authorAhmed, I.
dc.contributor.authorBirtle, A. J.
dc.contributor.authorBrock, S. J.
dc.contributor.authorDas, P.
dc.contributor.authorFord, V. A.
dc.contributor.authorGray, E. K.
dc.contributor.authorHughes, R. J.
dc.contributor.authorManetta, C. B.
dc.contributor.authorMcLaren, D. B.
dc.contributor.authorNikapota, A. D.
dc.contributor.authorO'Sullivan, J. M.
dc.contributor.authorPerna, C.
dc.contributor.authorPeedell, C.
dc.contributor.authorProtheroe, A. S.
dc.contributor.authorSundar, S.
dc.contributor.authorTanguay, J. S.
dc.contributor.authorTolan, S. P.
dc.contributor.authorWagstaff, J.
dc.contributor.authorWallace, J. B.
dc.contributor.authorWylie, James P
dc.contributor.authorZarkar, A.
dc.contributor.authorParmar, M. K. B.
dc.contributor.authorSydes, M. R.
dc.date.accessioned2022-08-17T09:45:40Z
dc.date.available2022-08-17T09:45:40Z
dc.date.issued2022en
dc.identifier.citationJames 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.en
dc.identifier.pmid35877084en
dc.identifier.doi10.1093/jncics/pkac043en
dc.identifier.urihttp://hdl.handle.net/10541/625446
dc.description.abstractBackground: 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.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1093/jncics/pkac043en
dc.titleDocetaxel for nonmetastatic prostate cancer: long-term survival outcomes in the STAMPEDE randomized controlled trialen
dc.typeArticleen
dc.contributor.departmentThe Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, UKen
dc.identifier.journalJNCI Cancer Spectrumen
dc.description.noteen]
refterms.dateFOA2022-08-22T12:30:31Z


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