{"id":5666,"date":"2019-10-30T14:56:22","date_gmt":"2019-10-30T14:56:22","guid":{"rendered":"http:\/\/www.library.sath.nhs.uk\/research\/?p=5666"},"modified":"2022-05-19T09:40:37","modified_gmt":"2022-05-19T08:40:37","slug":"addition-of-docetaxel-to-hormonal-therapy-in-low-and-high-burden-metastatic-hormone-sensitive-prostate-cancer-long-term-survival-results-from-the-stampede-trial-2019","status":"publish","type":"post","link":"https:\/\/www.library.sath.nhs.uk\/research\/2019\/10\/30\/addition-of-docetaxel-to-hormonal-therapy-in-low-and-high-burden-metastatic-hormone-sensitive-prostate-cancer-long-term-survival-results-from-the-stampede-trial-2019\/","title":{"rendered":"Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial (2019)"},"content":{"rendered":"

Type of publication:<\/strong>
\nJournal article<\/p>\n

Author(s):<\/strong>
\nClarke, N W; Ali, A; Ingleby, F C; Hoyle, A; Amos, C L; Attard, G; Brawley, C D; Calvert, J; Chowdhury, S; Cook, A; Cross, W; Dearnaley, D P; Douis, H; Gilbert, D; Gillessen, S; Jones, R J; Langley, R E; MacNair, A; Malik, Z; Mason, M D; Matheson, D; Millman, R; Parker, C C; Ritchie, A W S; Rush, H; Russell, J M; Brown, J; Beesley, S; Birtle, A; Capaldi, L; Gale, J; Gibbs, S; Lydon, A; Nikapota, A; Omlin, A; O'Sullivan, J M; Parikh, O; Protheroe, A; Rudman, S; *Srihari, N N; Simms, M; Tanguay, J S; Tolan, S; Wagstaff, J; Wallace, J; Wylie, J; Zarkar, A; Sydes, M R; Parmar, M K B; James, N D<\/p>\n

Citation:<\/strong>
\nAnnals of Oncology; Dec 2019 30(12) p. 1992-2003<\/p>\n

Abstract:<\/strong>
\nBACKGROUND STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone na\u00efve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients.
\nMETHODS We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden was categorised using retrospectively-collected baseline staging scans where available. Analysis used Cox regression models, adjusted for stratification factors, with emphasis on restricted mean survival time where hazards were non-proportional.
\nRESULTS Between 05 October 2005 and 31 March 2013, 1086 M1 patients were randomised to receive SOC (n = 724) or SOC + docetaxel (n = 362). Metastatic burden was assessable for 830\/1086 (76%) patients; 362 (44%) had low and 468 (56%) high metastatic burden. Median follow-up was 78.2 months. There were 494 deaths on SOC (41% more than the previous report). There was good evidence of benefit of docetaxel over SOC on OS (HR = 0.81, 95% CI 0.69-0.95, P = 0.009) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P = 0.827). Analysis of other outcomes found evidence of benefit for docetaxel over SOC in failure-free survival (HR = 0.66, 95% CI 0.57-0.76, P < 0.001) and progression-free survival (HR = 0.69, 95% CI 0.59-0.81, P < 0.001) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P > 0.5 in each case). There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression).
\nCONCLUSIONS The clinically significant benefit in survival for upfront docetaxel persists at longer follow-up, with no evidence that benefit differed by metastatic burden. We advocate that upfront docetaxel is considered for metastatic hormone na\u00efve prostate cancer patients regardless of metastatic burden.<\/p>\n

Link to full-text<\/a> [open access - no password required]<\/p>\n

See Erratum<\/a> - The authors regret that Fig.2F has been incorrectly titled. The correct title is \u201cFailure-free survival high burden M1\u201d.<\/p>\n

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