PMID- 25301760 OWN - NLM STAT- MEDLINE DCOM- 20160407 LR - 20221208 IS - 1873-7560 (Electronic) IS - 0302-2838 (Linking) VI - 67 IP - 6 DP - 2015 Jun TI - Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019). PG - 1028-1038 LID - S0302-2838(14)00969-5 [pii] LID - 10.1016/j.eururo.2014.09.032 [doi] AB - BACKGROUND: Prostate cancer (PCa) is the second most common disease among men worldwide. It is important to know survival outcomes and prognostic factors for this disease. Recruitment for the largest therapeutic randomised controlled trial in PCa--the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial (STAMPEDE)--includes men with newly diagnosed metastatic PCa who are commencing long-term androgen deprivation therapy (ADT); the control arm provides valuable data for a prospective cohort. OBJECTIVE: Describe survival outcomes, along with current treatment standards and factors associated with prognosis, to inform future trial design in this patient group. DESIGN, SETTING, AND PARTICIPANTS: STAMPEDE trial control arm comprising men newly diagnosed with M1 disease who were recruited between October 2005 and January 2014. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Overall survival (OS) and failure-free survival (FFS) were reported by primary disease characteristics using Kaplan-Meier methods. Hazard ratios and 95% confidence intervals (CIs) were derived from multivariate Cox models. RESULTS AND LIMITATIONS: A cohort of 917 men with newly diagnosed M1 disease was recruited to the control arm in the specified interval. Median follow-up was 20 mo. Median age at randomisation was 66 yr (interquartile range [IQR]: 61-71), and median prostate-specific antigen level was 112 ng/ml (IQR: 34-373). Most men (n=574; 62%) had bone-only metastases, whereas 237 (26%) had both bone and soft tissue metastases; soft tissue metastasis was found mainly in distant lymph nodes. There were 238 deaths, 202 (85%) from PCa. Median FFS was 11 mo; 2-yr FFS was 29% (95% CI, 25-33). Median OS was 42 mo; 2-yr OS was 72% (95% CI, 68-76). Survival time was influenced by performance status, age, Gleason score, and metastases distribution. Median survival after FFS event was 22 mo. Trial eligibility criteria meant men were younger and fitter than general PCa population. CONCLUSIONS: Survival remains disappointing in men presenting with M1 disease who are started on only long-term ADT, despite active treatments being available at first failure of ADT. Importantly, men with M1 disease now spend the majority of their remaining life in a state of castration-resistant relapse. PATIENT SUMMARY: Results from this control arm cohort found survival is relatively short and highly influenced by patient age, fitness, and where prostate cancer has spread in the body. CI - Copyright (c) 2014 The Authors. Published by Elsevier B.V. All rights reserved. FAU - James, Nicholas David AU - James ND AD - University of Warwick, Coventry, UK. Electronic address: N.D.James@warwick.ac.uk. FAU - Spears, Melissa R AU - Spears MR AD - Medical Research Council Clinical Trials Unit at University College London, London, UK. FAU - Clarke, Noel W AU - Clarke NW AD - Department of Urology, The Christie NHS Foundation Trust, Manchester, UK. FAU - Dearnaley, David P AU - Dearnaley DP AD - Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London and Sutton, UK. FAU - De Bono, Johann S AU - De Bono JS AD - Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London and Sutton, UK. FAU - Gale, Joanna AU - Gale J AD - Queen Alexandra Hospital, Portsmouth, UK. FAU - Hetherington, John AU - Hetherington J AD - Hull & East Yorkshire Hospitals NHS Trust, Hull, UK. FAU - Hoskin, Peter J AU - Hoskin PJ AD - Mount Vernon Hospital, Northwood, Middlesex, UK. FAU - Jones, Robert J AU - Jones RJ AD - University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK. FAU - Laing, Robert AU - Laing R AD - Royal Surrey County Hospital, Guildford, UK. FAU - Lester, Jason F AU - Lester JF AD - Velindre Hospital, Cardiff, UK. FAU - McLaren, Duncan AU - McLaren D AD - Western General Hospital, Edinburgh, UK. FAU - Parker, Christopher C AU - Parker CC AD - Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London and Sutton, UK. FAU - Parmar, Mahesh K B AU - Parmar MKB AD - Medical Research Council Clinical Trials Unit at University College London, London, UK. FAU - Ritchie, Alastair W S AU - Ritchie AWS AD - Medical Research Council Clinical Trials Unit at University College London, London, UK. FAU - Russell, J Martin AU - Russell JM AD - Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. FAU - Strebel, Rato T AU - Strebel RT AD - Kantonsspital Graubunden, Chur, Switzerland. FAU - Thalmann, George N AU - Thalmann GN AD - Department of Urology, University Hospital, Bern, Switzerland. FAU - Mason, Malcolm D AU - Mason MD AD - Velindre Hospital, Cardiff, UK. FAU - Sydes, Matthew R AU - Sydes MR AD - Medical Research Council Clinical Trials Unit at University College London, London, UK. LA - eng GR - MC_U122861330/MRC_/Medical Research Council/United Kingdom GR - 12459/CRUK_/Cancer Research UK/United Kingdom GR - MC_UU_12023/25/MRC_/Medical Research Council/United Kingdom GR - MC_UU_12023/6/MRC_/Medical Research Council/United Kingdom GR - 3804/CRUK_/Cancer Research UK/United Kingdom PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20141006 PL - Switzerland TA - Eur Urol JT - European urology JID - 7512719 RN - 0 (Androgen Antagonists) RN - 0 (Taxoids) RN - 15H5577CQD (Docetaxel) RN - EC 3.4.21.77 (Prostate-Specific Antigen) SB - IM CIN - Eur Urol. 2015 Jun;67(6):1039-41. PMID: 25544634 CIN - J Urol. 2016 Feb;195(2):350. PMID: 26852973 MH - Adult MH - Age Factors MH - Aged MH - Aged, 80 and over MH - Androgen Antagonists/*therapeutic use MH - Cohort Studies MH - Disease-Free Survival MH - Docetaxel MH - Early Detection of Cancer/mortality MH - Follow-Up Studies MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Neoplasm Grading MH - Neoplasm Metastasis/diagnosis/pathology/*therapy MH - Physical Fitness MH - Prognosis MH - Proportional Hazards Models MH - Prostate-Specific Antigen/blood MH - Prostatic Neoplasms/diagnosis/*drug therapy/mortality/pathology MH - Risk Factors MH - Taxoids/*therapeutic use MH - Treatment Outcome OTO - NOTNLM OT - Control arm cohort OT - Hormone-naive OT - Metastatic OT - Natural history OT - Prognostic factors OT - Prospective data OT - Prostate cancer OT - Survival OT - Time to progression EDAT- 2014/10/11 06:00 MHDA- 2016/04/08 06:00 CRDT- 2014/10/11 06:00 PHST- 2014/07/23 00:00 [received] PHST- 2014/09/19 00:00 [accepted] PHST- 2014/10/11 06:00 [entrez] PHST- 2014/10/11 06:00 [pubmed] PHST- 2016/04/08 06:00 [medline] AID - S0302-2838(14)00969-5 [pii] AID - 10.1016/j.eururo.2014.09.032 [doi] PST - ppublish SO - Eur Urol. 2015 Jun;67(6):1028-1038. doi: 10.1016/j.eururo.2014.09.032. Epub 2014 Oct 6.