Docetaxel for nonmetastatic prostate cancer: long-term survival outcomes in the STAMPEDE randomized controlled trial
dc.contributor.author | James, N. D. | |
dc.contributor.author | Ingleby, F. C. | |
dc.contributor.author | Clarke, Noel W | |
dc.contributor.author | Amos, C. | |
dc.contributor.author | Attard, G. | |
dc.contributor.author | Brawley, C. D. | |
dc.contributor.author | Chowdhury, S. | |
dc.contributor.author | Cross, W. | |
dc.contributor.author | Dearnaley, D. P. | |
dc.contributor.author | Gilbert, D. C. | |
dc.contributor.author | Gillessen, S. | |
dc.contributor.author | Jones, R. J. | |
dc.contributor.author | Langley, R. E. | |
dc.contributor.author | Macnair, A. | |
dc.contributor.author | Malik, Z. I. | |
dc.contributor.author | Mason, M. D. | |
dc.contributor.author | Matheson, D. J. | |
dc.contributor.author | Millman, R. | |
dc.contributor.author | Parker, C. C. | |
dc.contributor.author | Rush, H. L. | |
dc.contributor.author | Russell, J. M. | |
dc.contributor.author | Au, C. | |
dc.contributor.author | Ritchie, A. W. S. | |
dc.contributor.author | Mestre, R. P. | |
dc.contributor.author | Ahmed, I. | |
dc.contributor.author | Birtle, A. J. | |
dc.contributor.author | Brock, S. J. | |
dc.contributor.author | Das, P. | |
dc.contributor.author | Ford, V. A. | |
dc.contributor.author | Gray, E. K. | |
dc.contributor.author | Hughes, R. J. | |
dc.contributor.author | Manetta, C. B. | |
dc.contributor.author | McLaren, D. B. | |
dc.contributor.author | Nikapota, A. D. | |
dc.contributor.author | O'Sullivan, J. M. | |
dc.contributor.author | Perna, C. | |
dc.contributor.author | Peedell, C. | |
dc.contributor.author | Protheroe, A. S. | |
dc.contributor.author | Sundar, S. | |
dc.contributor.author | Tanguay, J. S. | |
dc.contributor.author | Tolan, S. P. | |
dc.contributor.author | Wagstaff, J. | |
dc.contributor.author | Wallace, J. B. | |
dc.contributor.author | Wylie, James P | |
dc.contributor.author | Zarkar, A. | |
dc.contributor.author | Parmar, M. K. B. | |
dc.contributor.author | Sydes, M. R. | |
dc.date.accessioned | 2022-08-17T09:45:40Z | |
dc.date.available | 2022-08-17T09:45:40Z | |
dc.date.issued | 2022 | en |
dc.identifier.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. | en |
dc.identifier.pmid | 35877084 | en |
dc.identifier.doi | 10.1093/jncics/pkac043 | en |
dc.identifier.uri | http://hdl.handle.net/10541/625446 | |
dc.description.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. | en |
dc.language.iso | en | en |
dc.relation.url | https://dx.doi.org/10.1093/jncics/pkac043 | en |
dc.title | Docetaxel for nonmetastatic prostate cancer: long-term survival outcomes in the STAMPEDE randomized controlled trial | en |
dc.type | Article | en |
dc.contributor.department | The Institute of Cancer Research and Royal Marsden NHS Foundation Trust, London, UK | en |
dc.identifier.journal | JNCI Cancer Spectrum | en |
dc.description.note | en] | |
refterms.dateFOA | 2022-08-22T12:30:31Z |