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

International Journal of Cancer2022Vol. 151(3), pp. 422–434

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Nicholas D. James, Noel W. Clarke, Adrian Cook, Adnan Ali, Alex Hoyle, Gerhardt Attard, Chris Brawley, Simon Chowdhury, William Cross, David P. Dearnaley, Johann S. de Bono, Carlos Díaz-Montaña, Duncan C. Gilbert, Silke Gillessen, Clare Gilson, Robert J. Jones, Ruth E. Langley, Zafar Malik, David Matheson, Robin Millman, Chris Parker, Cheryl Pugh, Hannah Rush, John M. Russell, Dominik Berthold, Michelle Buckner, Malcolm D. Mason, A.W.S. Ritchie, Alison Birtle, Susannah Brock, Prantik Das, Dan Ford, Joanna Gale, Warren Grant, Emma Gray, Peter Hoskin, Mohammad Muneeb Khan, Caroline Manetta, Neil McPhail, Joe M. O’Sullivan, Omi Parikh, Carla Perna, Carmel Pezaro, Andrew Protheroe, Angus Robinson, Sarah Maria Rudman, D.J. Sheehan, Narayanan Srihari, Isabel Syndikus, Jacob Tanguay, Carys Thomas, Salil Vengalil, John Wagstaff, James Wylie, Mahesh Parmar, Matthew R. Sydes, for the STAMPEDE Trials Collaborative Group

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 × 10-9 ) 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.

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Abstract

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