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Genitourinary tumours, prostate

3262 - Adding abiraterone acetate plus prednisolone (AAP) or docetaxel for patients (pts) with high-risk prostate cancer (PCa) starting long-term androgen deprivation therapy (ADT): directly randomised data from STAMPEDE (NCT00268476)

Date

08 Sep 2017

Session

Genitourinary tumours, prostate

Topics

Cytotoxic Therapy;  Prostate Cancer

Presenters

Matthew Sydes

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

M.R. Sydes1, M.D. Mason2, M.R. Spears3, N.W. Clarke4, D. Dearnaley5, A.W..S. Ritchie6, M. Russell7, C. Gilson1, R. Jones7, J. de Bono8, S. Gillessen9, R. Millman10, S. Tolan11, J. Wagstaff12, S. Chowdhury13, J. Lester14, D. Sheehan15, J. Gale16, M.K. Parmar3, N.D. James17

Author affiliations

  • 1 Institute Of Clinical Trials And Methodology, MRC Clinical Trials Unit at UCL, WC2B6NH - London/GB
  • 2 School Of Medicine, Cardiff University, Cardiff - Cardiff/GB
  • 3 Mrc Clinical Trials Unit At Ucl, Institute of Clinical Trials and Methodology, WC2B 6NH - London/GB
  • 4 Oncology, Royal Salford NHS Foundation Trust, Salford - M HD/GB
  • 5 Oncology, Institute of Cancer Research Royal Marsden Hospital, SM2 5PT - Sutton/GB
  • 6 Mrc Clinical Trials Unit, University College London, London/GB
  • 7 Oncology, University of Glasgow, Glasgow/GB
  • 8 Section Of Medicine, Institute of Cancer Research Royal Marsden Hospital, SM2 5PT - Sutton/GB
  • 9 Dept Of Medical Oncology, Kantonsspital, Switzerland/CH
  • 10 Clinical Trials Unit, MRC, London - WCB NH/GB
  • 11 Oncology, Clatterbridge Oncology Centre, Wirral/GB
  • 12 Medical Oncology, South West Wales Cancer Institute, Singleton Hospital, Swansea/GB
  • 13 Medical Oncology, Guy's and St. Thomas' Hospital NHS Trust, SE1 9RT - London/GB
  • 14 Oncology, Velindre, Wales/GB
  • 15 Urology, Royal Devon & Exeter Hospital NHS Foundation Trust, Exeter/GB
  • 16 Oncology, Queen Alexandra Hospital, Portsmouth/GB
  • 17 Oncology, Queen Elizabeth-University Hospital Birmingham NHS Foundation Trust, B15 2TT - Birmingham/GB
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Abstract 3262

Background

Adding abiraterone acetate + prednisone (AAP) & adding docetaxel + prednisone (DocP) to standard of care (SOC) each improved survival vs SOC in STAMPEDE: a multi-arm multi-stage platform randomised controlled protocol recruiting pts with high risk locally advanced or metastatic PCa starting long-term ADT. We share the first direct, randomised data of SOC+AAP or SOC+DocP using a STAMPEDE subset.

Methods

Recruitment to the “DocP comparison” & “AAP comparison” overlapped Nov2011 - Jan2014. SOC was long term ADT or 2+yr ADT with RT (for some M0). Stratified randomisation allocated pts 2:1:2 to SOC: or SOC + Doc 75mg/m2 3-weekly x6 + P 5mg twice daily: or SOC + AA 1000mg + P 5mg daily. AAP duration depended on stage & intent for radical RT. Primary outcome measure was death from any cause. Analyses used Cox proportional hazards & flexible parametric models, adjusted for stratification factors. This was not a formally powered comparison; power is limited, but is indicative of the likely magnitude of difference: HR  1 favours SOC+DocP. All confidence intervals (CI) are 95%.

Results

566 pts were contemporaneously randomised: 189 SOC+DocP (the last of 592 SOC+DocP pts) & 377 SOC+AAP (the first of 960 SOC+AAP pts). Groups were well balanced with 342 (60%) M1; 429 (76%) Gleason 8-10; 449 (79%) WHO PS 0; median age 66yr & PSA 56ng/ml. At median follow up 4 yr, there were 149 deaths (45 SOC+Doc, 111 SOC+AAP): survival HR 1.16 (0.82-1.65); failure free survival HR = 0.51 (0.39-0.67); progression free survival HR 0.65 (0.48-0.88); metastases free survival HR 0.77 (0.57-1.03); & SRE HR 0.83 (0.55-1.25). There was no heterogeneity by baseline M0/M1. Grade 3, 4, 5 toxicity was 36%, 13%, 1% SOC+DocP, & 40%, 7%, 1% SOC+AAP. Subsequent treatments varied by arm, with much crossing after progression.

Conclusions

In this direct, randomised, comparative analysis of 2 new standards for HNPC, FFS & PFS clearly favoured SOC+AAP &, with less certainty, MFS & SRE favoured SOC+AAP & survival SOC+Doc. Worst toxicity grade was similar. Drug availability may drive treatment choice. Published STAMPEDE data also contribute to a network MA (#2871).

Clinical trial identification

NCT00268476

Legal entity responsible for the study

Medical Research Council

Funding

Cancer Research UK, Medical Research Council, Janssen; Astellas, Clovis Oncology, Novartis, Pfizer, Sanofi-Aventis

Disclosure

M.R. Sydes: Grants and non-financial support from Janssen, Astellas, Clovis Oncology, Novartis, Pfizer, Sanofi-Aventis M.D. Mason: Personal fees and other from Sanofi, personal fees from Bayer, other from Janssen, outside the submitted work N.W. Clarke: Personal fees from Janssen Pharmaceuticals, during the conduct of the study; personal fees from Janssen Pharmaceuticals, outside the submitted work; . D. Dearnaley: Financial Support for Trial Recruitment M. Russell: Dr. Russell reports from Jannsen-Cilag, outside the submitted work. R. Jones: Personal fees and non-financial support from Janssen, grants, personal fees and other from Astellas, outside the submitted work. J. de Bono: Employee of the ICR which has a commercial interest in abiraterone. Has served on Janssen Advisory Board as a consultant. S. Gillessen: Bayer, CureVac, Janssen Cilag, Dendreon Corp, Astellas, Millennium Pharmaceuticals, Orion, Sanofi, MaxiVax SA, AAA, Bristol-Myers Squibb, Ferring, Roche, Innocrin Pharmaceuticals, Nektar Therapeutics, ProteoMedix. S. Chowdhury: Personal fees from Janssen Paharmaceutical, outside the submitted work; . J. Lester: Personal fees, non-financial support and other from Janssen, personal fees, non-financial support and other from Astellas, outside the submitted work. M.K. Parmar: Jansenn: Unrestricted grant to contribute to this comparison of STAMPEDE which supports the protocol overall, plus abiraterone and distribution. N.D. James: Grants, personal fees and non-financial support from Janssen, Astellas, Sanofi, Novartis during the conduct of the study; grants and non-financial support from Clovis Oncology, Pfizer All other authors have declared no conflicts of interest.

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