Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Proffered Paper - GU, prostate

611O - Abiraterone acetate plus prednisolone for hormone-naïve prostate cancer (PCa): Long-term results from metastatic (M1) patients in the STAMPEDE randomised trial (NCT00268476)

Date

21 Sep 2020

Session

Proffered Paper - GU, prostate

Presenters

Nicholas James

Citation

Annals of Oncology (2020) 31 (suppl_4): S507-S549. 10.1016/annonc/annonc275

Authors

N.D. James1, H. Rush2, N. Clarke3, G. Attard4, A. Cook2, D. Dearnaley1, S. Gillessen5, A. Hoyle6, R. Jones7, R. Millman8, A. Birtle9, S. Chowdhury10, J. Gale11, Z. Malik12, J. O'Sullivan13, C. Pezaro14, D. Sheehan15, J. Tanguay16, M.K. Parmar2, M.R. Sydes2

Author affiliations

  • 1 Institute Of Cancer Research, Institute of Cancer Research, SW3 6JB - London/GB
  • 2 Mrc Clinical Trials Unit At Ucl, Ucl Institute Of Clinical Trials And Methodology, UCL, WC1V 6LJ - London/GB
  • 3 Deptartment Of Urology, The Christie and Salford Royal NHS Foundation Trusts, M20 4BX - Manchester/GB
  • 4 Research Department Of Oncology, University College London Cancer Institute, WC1E6BT - London/GB
  • 5 Department Of Oncology/hematology  , The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 6 Department Of Urology, The Christie and Salford Royal Hospitals, Manchester/GB
  • 7 Research Department Of Oncology, Beatson West of Scotland Cancer Centre, G61 1BD - Glasgow/GB
  • 8 Medical Oncology, University College London NHS Foundation Trust, NW1 2PG - London/GB
  • 9 Medical Oncology, Royal Preston Hospital-Lancashire Teaching Hospitals NHS Foundation Trust, PR2 9HT - Preston/GB
  • 10 Department Of Medical Oncology, Guy's and St. Thomas' Hospital NHS Trust, SE1 9RT - London/GB
  • 11 Medical Oncology, Princess Alexandra Hospital, PO6 3L - Portsmouth/GB
  • 12 Medical Oncology, The Clatterbridge Cancer Centre NHS Foundation Trust, CH63 4JY - Wirral/GB
  • 13 Oncology, The Northern Ireland Cancer Centre, BT9 7AB - Belfast/GB
  • 14 Research Department Of Oncology, Sheffield teaching hospital, S10 2JF - Sheffield/GB
  • 15 Exeter Oncology Centre, RD&E Hospital, EX2 5DW - Devon/GB
  • 16 Department Of Urology, Velindre Cancer Centre, CF14 2TL - Cardiff/GB
More

Resources

Login to access the resources on OncologyPRO.

Abstract 611O

Background

Abiraterone acetate plus prednisolone previously showed a clear survival advantage in men starting long-term hormone therapy for prostate cancer in STAMPEDE, a randomized controlled trial using a multi-arm multi-stage platform design. STAMPEDE included a wide range of men with M1 or M0 disease. The LATITUDE trial, in patients with high-burden M1 disease only, reported a similar magnitude of effect to the comparable subset of STAMPEDE pts. We report long-term outcomes in the M1 subset of pts in STAMPEDE.

Methods

All patients received androgen deprivation therapy (ADT). Stratified randomization allocated pts 1:1 to ADT alone or adding daily abiraterone acetate 1000mg + prednisolone 5mg (SOC+AAP) continued until PSA, radiological & clinical progression. The primary outcome measure was death from any cause. The data freeze for this long-term analysis was planned for 3yr after the primary survival results when a meaningful increase in data was anticipated. Analyses used Cox proportional hazards & flexible parametric models, adjusted for baseline stratification factors.

Results

Of 1,917 pts contemporaneously randomized to these groups (Nov-2011 to Jan-2014), 1,003 (52%) had M1 disease. The M1 groups were balanced: median age 67yr; 48% high-burden, 44% low-burden, 8% burden not assessable; 94% newly-diagnosed; median PSA 97ng/ml. Median follow-up had increased from 3.5yr to 6.1yr & number of ADT-only deaths increased by 50%, from 218 previously to 329. With 244 ADT+AAP deaths, the adjusted HR=0·60 (95%CI 0·50—0·71; p=0.31x10-9) favouring ADT+AAP, with 5-yr survival improved from 41% ADT-only to 60% ADT+AAP. The relative effect of abiraterone was similar in low-burden (HR=0·55; 95%CI 0·41—0·76) and high-burden (HR=0·54; 95%CI 0·43—0·69) patients. Median time on ADT+AAP was 2.4yr, with a current maximum of 8.1yr. Toxicity at 4yr post-randomisation was similar, with 16% of patients in each group reporting grade 3 or higher toxicity.

Conclusions

A sustained and substantial improvement in overall survival of M1 prostate cancer patients was achieved with ADT + abiraterone acetate + prednisolone, irrespective of burden of disease.

Clinical trial identification

NCT00268476.

Editorial acknowledgement

Legal entity responsible for the study

UCL and the STAMPEDE investigators.

Funding

Janssen; Astellas, Clovis, Novartis, Pfizer, Sanofi Aventis.

Disclosure

N. James: Advisory/Consultancy, Advisory Board: Sanofi; Advisory/Consultancy, Advisory Board: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Advisory Board, speaker fees, assistance with travel: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Advisory Board, speaker fees, assistance with travel: Astellas; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Advisory Board, speaker fees, assistance with travel: Merck; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Advisory Board, speaker fees, assistance with travel: Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Advisory Board, speaker fees, assistance with travel: AstraZeneca. N. Clarke: Advisory/Consultancy, Consultation and advisory fees: Janssen; Advisory/Consultancy, Consultation/ Lecture fees: Astellas; Advisory/Consultancy, Consultation / Advisory fees: Bayer. G. Attard: Speaker Bureau/Expert testimony, Speakers' bureaus: Sanofi Aventis. D. Dearnaley: Research grant/Funding (institution), C46/A3976, C46/A10588 and C33589/A19727. : Cancer Research UK; Research grant/Funding (self), Consultant and Advisory Board Honoraria: Takeda; Research grant/Funding (self), Consultant and Advisory Board Honoraria: Amgen; Research grant/Funding (self), Consultant and Advisory Board Honoraria: Astellas; Advisory/Consultancy, Travel/Accommodation/Expenses, Advisory Board, Travel, Accommodation: Sandoz; Advisory/Consultancy, Travel/Accommodation/Expenses, Financial support for trial recruitment, Advisory Board, Speakers Bureau, Travel and Accommodation: Janssen. S. Gillessen: Honoraria (institution), Honorarium payments to hospital: Bayer; Honoraria (institution), Honorarium payments to hospital: Curevac; Honoraria (self), Honoraria (institution), Honorarium payments to hospital: Janssen; Honoraria (institution), Honorarium payments to hospital: Astellas; Honoraria (self), Honoraria (institution), Honorarium payments to hospital: Orion; Honoraria (institution), Honorarium payments to hospital: Max/Vax SA; Honoraria (institution), Honorarium payments to hospital: Ferring; Honoraria (institution), Honorarium payments to hospital: Roche; Honoraria (institution), Honorarium payments to hospital: Innocrin Pharmaceuticals; Honoraria (self), Honorarium payments to hospital: Sanofi; Honoraria (institution), Honorarium payments to hospital: Novartis; Non-remunerated activity/ies, Uncompensated advisory role: Nectar Therapeutics; Non-remunerated activity/ies, Uncompensated advisory role: ProteoMedix; Honoraria (institution), Honorarium payments to hospital: Cell Search; Honoraria (institution), Honorarium payments to hospital: Clovis; Honoraria (institution), Honorarium payments to hospital: Bristol-Myers Squibb; Honoraria (institution), Honorarium payments to hospital: MSD Merck Sharp & Dome. A. Birtle: Honoraria (self), Advisory/Consultancy, Advisory Board Honoraria: Astellas; Advisory/Consultancy, Speaker Bureau/Expert testimony, Speaker Fee + Advisory Board Honoraria: Sanofi; Honoraria (self), Advisory/Consultancy, Advisory Board Honoraria: Janssen; Advisory/Consultancy, Advisory Board Honoraria: Bayer; Advisory/Consultancy, Advisory Board Honoraria: Astra Zeneca. S. Chowdhury: Honoraria (self), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses, Honoraria, Speakers fee, Travel Grant: Janssen. Z. Malik: Advisory/Consultancy, Advisory boards: Sanofi; Advisory/Consultancy, Advisory boards: Janssen; Advisory/Consultancy, Advisory boards: Pfizer; Travel/Accommodation/Expenses, Assisted travel to Congress: Bayer. J. O'Sullivan: Advisory/Consultancy, Speaker Bureau/Expert testimony, Ad boards + Speakers fees: Janssen; Advisory/Consultancy, Speaker Bureau/Expert testimony, Ad boards + Speakers fees: Atellas; Advisory/Consultancy, Speaker Bureau/Expert testimony, Ad boards + Speakers fees: Bayer. C. Pezaro: Honoraria (self), Honoraria (institution): Astellas; Honoraria (self), Honoraria (institution): AstraZeneca; Honoraria (self), Honoraria (institution): Janssen; Honoraria (self), Honoraria (institution): Mundipharma; Honoraria (self), Honoraria (institution): Pfizer; Travel/Accommodation/Expenses: Bayer; Travel/Accommodation/Expenses: Janssen. D. Sheehan: Travel/Accommodation/Expenses, Sponsorship for meeting attendance: Astellas; Travel/Accommodation/Expenses, Sponsorship for meeting attendance: Ipsen. J. Tanguay: Travel/Accommodation/Expenses, Conference attendance: Roche; Travel/Accommodation/Expenses, Conference attendance: Janssen; Advisory/Consultancy, Advisory board: Astellas; Advisory/Consultancy, Travel/Accommodation/Expenses, Advisory board & conference attendance: Bayer; Advisory/Consultancy, Advisory board: AstraZeneca. M.K. Parmar: Research grant/Funding (institution), Unrestricted grant to contribute to another comparison of STAMPEDE which supports the protocol overall, plus relevant drug and distribution.: Astellas; Research grant/Funding (institution), Unrestricted grant to contribute to another comparison of STAMPEDE which supports the protocol overall, plus relevant drug and distribution.: Clovis; Research grant/Funding (institution), Unrestricted grant to contribute to another comparison of STAMPEDE which supports the protocol overall, plus relevant drug and distribution.: Novartis; Research grant/Funding (institution), Unrestricted grant to contribute to another comparison of STAMPEDE which supports the protocol overall, plus relevant drug and distribution.: Pfizer; Research grant/Funding (institution), Unrestricted grant to contribute to another comparison of STAMPEDE which supports the protocol overall, plus relevant drug and distribution.: Sanofi. M.R. Sydes: Research grant/Funding (institution): Astellas; Research grant/Funding (institution): Clovis; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Janssen; Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Pfizer; Research grant/Funding (institution): Sanofi-Aventis; Honoraria (self): Eli-Lilly. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.