Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial.

STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients.

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.

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).

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 naïve prostate cancer patients regardless of metastatic burden.

Annals of oncology : official journal of the European Society for Medical Oncology. 2019 Sep 27 [Epub ahead of print]

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

Department of Urology, The Christie and Salford Royal NHS Foundation Trusts, Manchester., Genito-Urinary Cancer Research Group, Division of Cancer Sciences, The University of Manchester, Manchester., MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London., UCL Cancer Institute, London., Guy's and Saint Thomas' NHS Foundation Trust, London., St James University Hospital, Leeds., Institute of Cancer Research, Sutton-London., Department of Radiology, University Hospitals Birmingham NHS Foundation Trust, Birmingham., Division of Cancer Sciences, The University of Manchester, Manchester., Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow., The Clatterbridge Cancer Centre NHS Foundation Trust, Liverpool., Cardiff University, Cardiff., Faculty of Education Health and Wellbeing, University of Wolverhampton, Wolverhampton., Institute of Cancer Sciences, Beatson West of Scotland Cancer Centre, Glasgow., University of Sheffield, Sheffield., Kent Oncology Centre, Maidstone., Lancashire Teaching Hospitals NHS Foundation Trust, Preston., Worcestershire Acute Hospitals NHS Trust, Worcester., Portsmouth Oncology Centre, Queen Alexandra Hospital, Portsmouth., Queen's Hospital, Romford., Torbay and South Devon NHS Foundation Trust, Torbay., Sussex Cancer Centre, Brighton., Department of Oncology and Haematology, Kantonsspital, St Gallen, Switzerland., Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast., East Lancashire Hospitals NHS Trust, Blackburn., Oxford University Hospitals NHS Foundation Trust, Oxford., Shrewsbury and Telford Hospital NHS Trust, Shrewsbury., Hull and East Yorkshire Hospitals NHS Trust, Hull., Velindre Cancer Centre, Cardiff., Swansea University College of Medicine, Swansea., The Christie NHS Foundation Trust, Manchester., Heartlands Hospital, Birmingham., Institute of Cancer and Genomic Sciences, University of Birmingham, Birmingham.

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