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Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial / Nicholas D James; Matthew R Sydes; Noel W Clarke; Malcolm D Mason; David P Dearnaley; Melissa R Spears; Alastair W S Ritchie; Christopher C Parker; J Martin Russell; Gerhardt Attard; Johann de Bono; William Cross; Rob J Jones; George Thalmann; Claire Amos; David Matheson; Robin Millman; Mymoona Alzouebi; Sharon Beesley; Alison J Birtle; Susannah Brock; Richard Cathomas; Prabir Chakraborti; Simon Chowdhury; Audrey Cook; Tony Elliott; Joanna Gale; Stephanie Gibbs; John D Graham; John Hetherington; Robert Hughes; Robert Laing; Fiona McKinna; Duncan B McLaren; Joe M O'Sullivan; Omi Parikh; Clive Peedell; Andrew Protheroe; Angus J Robinson; Narayanan Srihari; Rajaguru Srinivasan; John Staffurth; Santhanam Sundar; Shaun Tolan; David Tsang; John Wagstaff; Mahesh K B Parmar
Swansea University Author: John, Wagstaff
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DOI (Published version): 10.1016/S0140-6736(15)01037-5
In this multi arm multi stage designed trial 2962 men with hormone sensitive prostate cancer were randomised to one of four arms. The control arm consisted of either surgical or chemical castration alone (standard of care (SOC)). In all other arms patients received either surgical or chemical castra...
|Published in:||The Lancet|
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In this multi arm multi stage designed trial 2962 men with hormone sensitive prostate cancer were randomised to one of four arms. The control arm consisted of either surgical or chemical castration alone (standard of care (SOC)). In all other arms patients received either surgical or chemical castration plus docetaxel (Doc) alone, zoledronic acid (ZA) alone or Doc plus ZA. 1817 (61%) men had metastatic (M)+ disease, 448 (15%) had nodal (N)+/X M0, and 697 (24%) had N0M0. Median overall survival was 71 months for SOC alone, not reached for SOC+ZA (p=0.45), 81 months for SOC+Doc (p=0.006) & 76 months for SOC+Doc+ZA (0.022). Grade 3–5 adverse events were reported for 399 (32%) patients receiving SOC, 197 (32%) receiving SOC+ZA, 288 (52%) receiving SOC+Doc, and 269 (52%) receiving SOC + ZA + Doc. ZA showed no evidence of survival benefit and should not be part of SOC. Doc showed a significant improvement in overall survival and should become SOC for suitably fit men with prostate cancer starting long term hormone therapy.
prostate cancer, docetaxel, zoledronic acid, hormone therapy
Swansea University Medical School