Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5‐year follow‐up results from the STAMPEDE randomised trial (NCT00268476)
Authors
James, Nicholas DClarke, Noel W
Cook, Adrian
Ali, Adnan
Hoyle, Alex P
Attard, Gerhardt
Brawley, Chris D
Chowdhury, Simon
Cross, William R
Dearnaley, David P
Bono, Johann S
Montana, Carlos Diaz
Gilbert, Duncan
Gillessen, Silke
Gilson, Clare
Jones, Rob J
Langley, Ruth E
Malik, Zafar I
Matheson, David
Millman, Robin
Parker, Chris C
Pugh, Cheryl
Rush, Hannah
Russell, J Martin
Berthold, Dominic R
Buckner, Michelle L
Mason, Malcolm D
Ritchie, Alastair WS
Birtle, Alison J
Brock, Susannah J
Das, Prantik
Ford, Dan
Gale, Joanna
Grant, Warren
Gray, Emma K
Hoskin, Peter
Khan, Mohammad M
Manetta, Caroline
McPhail, Neil J
O'Sullivan, Joe M
Parikh, Omi
Perna, Carla
Pezaro, Carmel J
Protheroe, Andrew S
Robinson, Angus J
Rudman, Sarah M
Sheehan, Denise J
Srihari, Narayanan N
Syndikus, Isabel
Tanguay, Jacob
Thomas, Carys W
Vengalil, Salil
Wagstaff, John
Wylie, James P
Parmar, Mahesh KB
Sydes, Matthew R
Issue Date
2022-04-12
Metadata
Show full item recordAbstract
Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multi-arm, multi-stage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis in metastatic patients was planned for 3 yrs after the first results. Standard-of-care (SOC) was androgen deprivation therapy. The comparison randomized 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 & flexible parametric models, adjusted for baseline stratification factors. 1003 patients were contemporaneously randomized (Nov-2011--Jan-2014): median age 67 yr; 94% newly-diagnosed; metastatic disease risk group: 48% high, 44% low, 8% un-assessable; median PSA 97 ng/mL. At 6.1 yr 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 = 0.31x10−9) favoured SOC + AAP, with 5-yr 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 yr and 8.1 yr. Toxicity at 4 yr post-randomisation 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.Citation
James, N.D., Clarke, N.W., Cook, A. et al. (2022) Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5‐year follow‐up results from the STAMPEDE randomised trial (NCT00268476). International Journal of Cancer, 151(3), pp. 422-434. https://doi.org/10.1002/ijc.34018Publisher
WileyJournal
International Journal of CancerAdditional Links
https://onlinelibrary.wiley.com/doi/10.1002/ijc.34018Type
Journal articleLanguage
enDescription
© 2022 The Authors. Published by Wiley. This is an open access article available under a Creative Commons licence. The published version can be accessed at the following link on the publisher’s website: https://doi.org/10.1002/ijc.34018ISSN
0020-7136EISSN
1097-0215Sponsors
Cancer Research UK, (CRUK_A12459), Medical Research Council (MRC_MC_UU_12023/25, MC_UU_00004/01), UK Clinical Research Network, and the Swiss Group for Cancer Clinical Research (SAKK).ae974a485f413a2113503eed53cd6c53
10.1002/ijc.34018
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