{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T23:27:06Z","timestamp":1782170826086,"version":"3.54.5"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"4","license":[{"start":{"date-parts":[[2022,7,25]],"date-time":"2022-07-25T00:00:00Z","timestamp":1658707200000},"content-version":"vor","delay-in-days":24,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000289","name":"Cancer Research UK","doi-asserted-by":"publisher","award":["CRUK_A12459"],"award-info":[{"award-number":["CRUK_A12459"]}],"id":[{"id":"10.13039\/501100000289","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MRC_MC_UU_12023\/25"],"award-info":[{"award-number":["MRC_MC_UU_12023\/25"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MC_UU_00004\/01"],"award-info":[{"award-number":["MC_UU_00004\/01"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Clovis"},{"DOI":"10.13039\/100005565","name":"Janssen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005565","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004336","name":"Novartis","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004336","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100014461","name":"Biomedical Research Centre","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014461","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,7,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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 (\u03b1\u2009=\u20090.05) 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).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Median follow-up was 6.5\u2009years with 142 mPFS events on SOC (3\u2009year and 54% increases over previous report). There was no good evidence of an advantage to SOC plus docetaxel on mPFS (HR\u2009=\u20090.89, 95% confidence interval [CI] = 0.66 to 1.19; P\u2009=\u2009.43); 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\u2009=\u20090.70, 95% CI = 0.55 to 0.88; P\u2009=\u2009.002) and PFS (nonproportional P\u2009=\u2009.03, restricted mean survival time difference\u2009=\u20095.8\u2009months, 95% CI = 0.5 to 11.2; P\u2009=\u2009.03) but no good evidence of overall survival benefit (125 SOC deaths; HR\u2009=\u20090.88, 95% CI = 0.64 to 1.21; P\u2009=\u2009.44). There was no evidence SOC plus docetaxel increased late toxicity: post 1 year, 29% SOC and 30% SOC plus docetaxel grade 3-5 toxicity.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jncics\/pkac043","type":"journal-article","created":{"date-parts":[[2022,7,25]],"date-time":"2022-07-25T15:13:59Z","timestamp":1658762039000},"source":"Crossref","is-referenced-by-count":23,"title":["Docetaxel for Nonmetastatic Prostate Cancer: Long-Term Survival Outcomes in the STAMPEDE Randomized Controlled Trial"],"prefix":"10.1093","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7314-8204","authenticated-orcid":false,"given":"Nicholas D","family":"James","sequence":"first","affiliation":[{"name":"Division of Radiotherapy and Imaging, The Institute of Cancer Research and Royal Marsden NHS Foundation Trust , London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1800-2015","authenticated-orcid":false,"given":"Fiona C","family":"Ingleby","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, UCL , London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7776-8059","authenticated-orcid":false,"given":"Noel W","family":"Clarke","sequence":"additional","affiliation":[{"name":"The Christie and Salford Royal Hospitals , Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire L","family":"Amos","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, UCL , London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4811-7983","authenticated-orcid":false,"given":"Gerhardt","family":"Attard","sequence":"additional","affiliation":[{"name":"UCL Cancer Institute , London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3641-278X","authenticated-orcid":false,"given":"Christopher D","family":"Brawley","sequence":"additional","affiliation":[{"name":"MRC Clinical Trials Unit at University College London (UCL), Institute of Clinical Trials and Methodology, UCL , London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Chowdhury","sequence":"additional","affiliation":[{"name":"Guy\u2019s and St. Thomas\u2019 NHS Foundation Trust , London, UK"},{"name":"Sarah Cannon Research Institute , London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9276-3053","authenticated-orcid":false,"given":"William","family":"Cross","sequence":"additional","affiliation":[{"name":"St James\u2019s University Hospital , Leeds, 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