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Abiraterone acetate plus prednisolone for hormone-naive prostate cancer (PCa): Long-term results from metastatic (M1) patients in the STAMPEDE randomised trial (NCT00268476)
James, N. Rush, H. Attard, G. Cook, A. Dearnaley, D Gillessen, Silke Hoyle, Alex P Jones, R. Millman, R.
James, N.
Rush, H.
Attard, G.
Cook, A.
Dearnaley, D
Gillessen, Silke
Hoyle, Alex P
Jones, R.
Millman, R.
Citations
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Abstract
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% newlydiagnosed;
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 HR¼0$60 (95%CI 0$50d0$71; p¼0.31x10-9) 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 (HR¼0$55; 95%CI
0$41d0$76) and high-burden (HR¼0$54; 95%CI 0$43d0$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.
Description
Date
2020
Publisher
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Keywords
Type
Meetings and Proceedings
Citation
James N, Rush H, Clarke N, Attard G, Cook A, Dearnaley D, et al. 611O Abiraterone acetate plus prednisolone for hormone-naïve prostate cancer (PCa): Long-term results from metastatic (M1) patients in the STAMPEDE randomised trial (NCT00268476). Annals of Oncology. 2020;31:S509-S.