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Nicholas James University of Warwick and Queen Elizabeth Hospital Birmingham on behalf of

Docetaxel +/- zoledronic acid for hormone-naïve prostate cancer: First overall survival results from STAMPEDE & treatment effects within subgroups (NCT00268476). Nicholas James University of Warwick and Queen Elizabeth Hospital Birmingham on behalf of

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Nicholas James University of Warwick and Queen Elizabeth Hospital Birmingham on behalf of

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  1. Docetaxel +/- zoledronic acid for hormone-naïve prostate cancer: First overall survival results from STAMPEDE & treatment effects within subgroups (NCT00268476) Nicholas JamesUniversity of Warwick and Queen Elizabeth Hospital Birminghamon behalf of Matthew Sydes, Malcolm Mason, Noel Clarke, David Dearnaley, Melissa Spears, Robin Millman, Chris Parker, Alastair Ritchie, J. Martin Russell, John Staffurth, Robert Jones, Richard Cathomas, Angus Robinson, Simon Chowdhury, David Tsang, Susannah Brock, Omi Parikh, John Graham, Mahesh Parmarand the STAMPEDE Investigators

  2. “Docetaxel comparison”: Metastatic at presentation SOC 350 deaths SOC+Doc 144 deaths HR (95%CI) 0.76 (0.62, 0.92) SOC+Doc SOC

  3. What is the current evidence for docetaxel or bisphosphonates in men with hormone sensitive prostate cancer? A systematic review and meta-analyses Claire Vale MRC Clinical Trials Unit at UCL Systemic Treatment Options for Cancer of the Prostate Working Group: Rydzewska LH, Tierney JF, Albiges L, Clarke NW, Fisher D, Fizazi K, James ND, Mason MD, Parmar MKB, Sweeney CJ, Sydes MR, Tombal B and Burdett S Vale, C et al. Lancet Oncology 2015 in press

  4. Trial name CHAARTED GETUG15 STAMPEDE (SOC +/- Doc) STAMPEDE (SOC+ZA +/- Doc) Overall HR=0.77 (0.68, 0.87) p<0.0001 .5 1 2 M1 docetaxel: Survival • Results based on 2993 men / 1254 deaths Favours SOC + docetaxel Favours SOC Heterogeneity:2=4.80, df=3, p=0.187, I2 = 37.5% 10% absolute improvement in survival (from 40% to 50%) at 4 years Vale, C et al. Lancet Oncology 2015 in press

  5. Trials showing survival advantage in metastatic patients *BSC: best supportive care; HR: hazard ratio; mCRPC: metastatic CRPC 1James, N et al. Eur J Cancer 2015;51(S3): abstract 19LBA (presented at ECC 2015; 2Tannock IF et al. NEJM 2004;351:1502-12; 3Kantoff PW et al. NEJM 2010;363:411–22; 4de Bono JS et al. Lancet 2010;376:1147-54;5 Fizazi K et al. Lancet Oncol 2012;13:983-92; 6Scher HI et al. NEJM 2012;367:1187-97; 7Parker C et al. NEJM 2013;369:213-23; 8Beer et al. NEJM 2014;371:424-33; 9Ryan C et al. Lancet Oncol 2015;16:152–60

  6. Conclusions • Survival data from STAMPEDE show a clinically & statistically significant improvement in survival from adding docetaxel in men starting long-term HT for the first time. • Docetaxel also significantly prolonged time to first reported SSE. • There is no evidence supporting the introduction of zoledronic acid. • Multi-arm, multi-stage trials are practicable and efficient.

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