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dc.contributor.authorJames, N.
dc.contributor.authorRush, H.
dc.contributor.authorClarke, Noel W
dc.contributor.authorAttard, G.
dc.contributor.authorCook, A.
dc.contributor.authorDearnaley, D
dc.contributor.authorGillessen, Silke
dc.contributor.authorHoyle, Alex P
dc.contributor.authorJones, R.
dc.contributor.authorMillman, R.
dc.contributor.authorBirtle, A.
dc.contributor.authorChowdhury, S.
dc.contributor.authorGale, J.
dc.contributor.authorMalik, Z.
dc.contributor.authorO'Sullivan, J.
dc.contributor.authorPezaro, C.
dc.contributor.authorSheehan, D.
dc.contributor.authorTanguay, J.
dc.contributor.authorParmar, M. K.
dc.contributor.authorSydes, M. R.
dc.date.accessioned2020-12-08T05:36:25Z
dc.date.available2020-12-08T05:36:25Z
dc.date.issued2020en
dc.identifier.citationJames 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.en
dc.identifier.doi10.1016/j.annonc.2020.08.871en
dc.identifier.urihttp://hdl.handle.net/10541/623457
dc.description.abstractBackground: 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.en
dc.language.isoenen
dc.relation.urlhttps://dx.doi.org/10.1016/j.annonc.2020.08.871en
dc.titleAbiraterone acetate plus prednisolone for hormone-naive prostate cancer (PCa): Long-term results from metastatic (M1) patients in the STAMPEDE randomised trial (NCT00268476)en
dc.typeMeetings and Proceedingsen
dc.contributor.departmentInstitute of Cancer Research, Institute of Cancer Research, London, UKen
dc.identifier.journalAnnals of Oncologyen
dc.description.noteen]
refterms.dateFOA2020-12-08T13:27:24Z


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