Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer:directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol
| Title: | Adding abiraterone or docetaxel to long-term hormone therapy for prostate cancer:directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol |
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| Authors: | Sydes, Matthew R; Spears, Melissa; Mason, Malcolm; Clarke, Noel; Dearnaley, David P.; de Bono, Johann; Attard, Gerhardt; Chowdhury, Simon; Cross, William; Gillessen Sommer, Silke; Malik, Zaf; Jones, Rob; Parker, Chris; Ritchie, Alastair W.S; Russell, J Martin; Millman, Robin; Matheson, David; Amos, C; Gilson, Clare; Birtle, Alison; Brock, Samantha; Capaldi, Lisa; Chakraborti, P; Choudhury, Ananya; Evans, L.; Ford, D; Gale, Joanna; Gibbs, Stephanie; Gilbert, Duncan C.; Hughes, Robert; McLaren, Duncan; Lester, Jason; Nikapota, Ashok; O'Sullivan, Joe; Parikh, Omi; Peedell, C; Protheroe, Andrew; Rudman, S.; Shaffer, Richard; Sheehan, Denise; Simms, Matthew; Srihari, Narayanan; Strebel, R; Sundar, Santhanam; Tolan, Shaun; Tsang, David; Varughese, Mohini; Wagstaff, John; Parmar, Mahesh K B; James, Nicholas |
| Source: | Sydes, M R, Spears, M, Mason, M, Clarke, N, Dearnaley, D P, de Bono, J, Attard, G, Chowdhury, S, Cross, W, Gillessen Sommer, S, Malik, Z, Jones, R, Parker, C, Ritchie, A W S, Russell, J M, Millman, R, Matheson, D, Amos, C, Gilson, C, Birtle, A, Brock, S, Capaldi, L, Chakraborti, P, Choudhury, A, Evans, L, Ford, D, Gale, J, Gibbs, S, Gilbert, D C, Hughes, R, McLaren, D, Lester, J, Nikapota, A, O'Sullivan, J, Parikh, O, Peedell, C, Protheroe, A, Rudman, S, Shaffer, R, Sheehan, D, Simms, M, Srihari, N, Strebel, R, Sundar, S, Tolan, S, Tsang, .... |
| Publication Year: | 2018 |
| Collection: | The University of Manchester: Research Explorer - Publications |
| Subject Terms: | Abiraterone; Docetaxel; Head-to-head; Prostate cancer; Randomised; Treatment; ResearchInstitutes_Networks_Beacons/mcrc; name=Manchester Cancer Research Centre |
| Description: | Background: Adding abiraterone acetate with prednisolone (AAP) or docetaxel with prednisolone (DocP) to standard-of-care (SOC) each improved survival in systemic therapy for advanced or metastatic prostate cancer: evaluation of drug efficacy: a multi-arm multi-stage platform randomised controlled protocol recruiting patients with high-risk locally advanced or metastatic PCa starting long-term androgen deprivation therapy (ADT). The protocol provides the only direct, randomised comparative data of SOC+AAP versus SOC+DocP. Method: Recruitment to SOC+DocP and SOC+AAP overlapped November 2011 to March 2013. SOC was long-term ADT or, for most non-metastatic cases, ADT for≥2 years and RT to the primary tumour. Stratified randomisation allocated pts 2: 1: 2 to SOC; SOC+docetaxel 75 mg/m 2 3-weekly×6+prednisolone 10mg daily; or SOC+abiraterone acetate 1000mg+prednisolone 5mg daily. AAP duration depended on stage and intent to give radical RT. The primary outcome measure was death from any cause. Analyses used Cox proportional hazards and flexible parametric models, adjusted for stratification factors. This was not a formally powered comparison. A hazard ratio (HR) < 1 favours SOC+AAP, and HR > 1 favours SOC+DocP. Results: A total of 566 consenting patients were contemporaneously randomised: 189 SOC+DocP and 377 SOC+AAP. The patients, balanced by allocated treatment were: 342 (60%) M1; 429 (76%) Gleason 8-10; 449 (79%) WHO performance status 0; median age 66 years and median PSA 56 ng/ml. With median follow-up 4 years, 149 deaths were reported. For overall survival, HR=1.16 (95% CI 0.82-1.65); failure-free survival HR=0.51 (95% CI 0.39-0.67); progression-free survival HR=0.65 (95% CI 0.48- 0.88); metastasis-free survival HR=0.77 (95% CI 0.57-1.03); prostate cancer-specific survival HR=1.02 (0.70-1.49); and symptomatic skeletal events HR=0.83 (95% CI 0.55-1.25). In the safety population, the proportion reporting≥1 grade 3, 4 or 5 adverse events ever was 36%, 13% and 1% SOC+DocP, and 40%, 7% and 1% SOC+AAP; ... |
| Document Type: | article in journal/newspaper |
| Language: | English |
| ISSN: | 0923-7534; 1569-8041 |
| Relation: | info:eu-repo/semantics/altIdentifier/pmid/29529169; info:eu-repo/semantics/altIdentifier/wos/000432668100024; info:eu-repo/semantics/altIdentifier/pissn/0923-7534; info:eu-repo/semantics/altIdentifier/eissn/1569-8041; info:eu-repo/semantics/reference/pmid/40865526 |
| DOI: | 10.1093/annonc/mdy072 |
| Availability: | https://research.manchester.ac.uk/en/publications/99a1dfb5-9bbe-4e66-beb1-a06a22d408f7; https://doi.org/10.1093/annonc/mdy072; https://www.scopus.com/pages/publications/85045001847 |
| Rights: | info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: | edsbas.9D627245 |
| Database: | BASE |