Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5-year follow-up results from the STAMPEDE randomised trial (NCT00268476).

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_A1169D8AF655
Type
Article: article from journal or magazin.
Publication sub-type
Minutes: analyse of a published work.
Collection
Publications
Institution
Title
Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5-year follow-up results from the STAMPEDE randomised trial (NCT00268476).
Journal
International journal of cancer
Author(s)
James N.D., Clarke N.W., Cook A., Ali A., Hoyle A.P., Attard G., Brawley C.D., Chowdhury S., Cross W.R., Dearnaley D.P., de Bono J.S., Diaz-Montana C., Gilbert D., Gillessen S., Gilson C., Jones R.J., Langley R.E., Malik Z.I., Matheson D.J., Millman R., Parker C.C., Pugh C., Rush H., Russell J.M., Berthold D.R., Buckner M.L., Mason M.D., Ritchie AWS, Birtle A.J., Brock S.J., Das P., Ford D., Gale J., Grant W., Gray E.K., Hoskin P., Khan M.M., Manetta C., McPhail N.J., O'Sullivan J.M., Parikh O., Perna C., Pezaro C.J., Protheroe A.S., Robinson A.J., Rudman S.M., Sheehan D.J., Srihari N.N., Syndikus I., Tanguay J.S., Thomas C.W., Vengalil S., Wagstaff J., Wylie J.P., Parmar MKB, Sydes M.R.
Working group(s)
STAMPEDE Trials Collaborative Group
ISSN
1097-0215 (Electronic)
ISSN-L
0020-7136
Publication state
Published
Issued date
01/08/2022
Peer-reviewed
Oui
Volume
151
Number
3
Pages
422-434
Language
english
Notes
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multiarm, multistage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis in metastatic patients was planned for 3 years after the first results. Standard-of-care (SOC) was androgen deprivation therapy. The comparison randomised patients 1:1 to SOC-alone with or without daily abiraterone acetate 1000 mg + prednisolone 5 mg (SOC + AAP), continued until disease progression. The primary outcome measure was overall survival. Metastatic disease risk group was classified retrospectively using baseline CT and bone scans by central radiological review and pathology reports. Analyses used Cox proportional hazards and flexible parametric models, accounting for baseline stratification factors. One thousand and three patients were contemporaneously randomised (November 2011 to January 2014): median age 67 years; 94% newly-diagnosed; metastatic disease risk group: 48% high, 44% low, 8% unassessable; median PSA 97 ng/mL. At 6.1 years median follow-up, 329 SOC-alone deaths (118 low-risk, 178 high-risk) and 244 SOC + AAP deaths (75 low-risk, 145 high-risk) were reported. Adjusted HR = 0.60 (95% CI: 0.50-0.71; P = 0.31 × 10 <sup>-9</sup> ) favoured SOC + AAP, with 5-years survival improved from 41% SOC-alone to 60% SOC + AAP. This was similar in low-risk (HR = 0.55; 95% CI: 0.41-0.76) and high-risk (HR = 0.54; 95% CI: 0.43-0.69) patients. Median and current maximum time on SOC + AAP was 2.4 and 8.1 years. Toxicity at 4 years postrandomisation was similar, with 16% patients in each group reporting grade 3 or higher toxicity. A sustained and substantial improvement in overall survival of all metastatic prostate cancer patients was achieved with SOC + abiraterone acetate + prednisolone, irrespective of metastatic disease risk group.
Keywords
Abiraterone Acetate/therapeutic use, Aged, Androgen Antagonists/therapeutic use, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Follow-Up Studies, Hormones, Humans, Male, Prednisolone/therapeutic use, Prednisone/therapeutic use, Prostatic Neoplasms/pathology, Prostatic Neoplasms, Castration-Resistant/drug therapy, Retrospective Studies, Treatment Outcome, abiraterone, clinical trial, hormone therapy, phase III, prostate cancer, randomised controlled trial, survival
Pubmed
Web of science
Open Access
Yes
Create date
16/03/2023 15:17
Last modification date
26/09/2023 6:14
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