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dc.contributor.authorSydes, MRen_US
dc.contributor.authorSpears, MRen_US
dc.contributor.authorMason, MDen_US
dc.contributor.authorClarke, NWen_US
dc.contributor.authorDearnaley, DPen_US
dc.contributor.authorde Bono, JSen_US
dc.contributor.authorAttard, Gen_US
dc.contributor.authorChowdhury, Sen_US
dc.contributor.authorCross, Wen_US
dc.contributor.authorGillessen, Sen_US
dc.contributor.authorMalik, ZIen_US
dc.contributor.authorJones, Ren_US
dc.contributor.authorParker, CCen_US
dc.contributor.authorRitchie, AWSen_US
dc.contributor.authorRussell, JMen_US
dc.contributor.authorMillman, Ren_US
dc.contributor.authorMatheson, Den_US
dc.contributor.authorAmos, Cen_US
dc.contributor.authorGilson, Cen_US
dc.contributor.authorBirtle, Aen_US
dc.contributor.authorBrock, Sen_US
dc.contributor.authorCapaldi, Len_US
dc.contributor.authorChakraborti, Pen_US
dc.contributor.authorChoudhury, Aen_US
dc.contributor.authorEvans, Len_US
dc.contributor.authorFord, Den_US
dc.contributor.authorGale, Jen_US
dc.contributor.authorGibbs, Sen_US
dc.contributor.authorGilbert, DCen_US
dc.contributor.authorHughes, Ren_US
dc.contributor.authorMcLaren, Den_US
dc.contributor.authorLester, JFen_US
dc.contributor.authorNikapota, Aen_US
dc.contributor.authorO'Sullivan, Jen_US
dc.contributor.authorParikh, Oen_US
dc.contributor.authorPeedell, Cen_US
dc.contributor.authorProtheroe, Aen_US
dc.contributor.authorRudman, SMen_US
dc.contributor.authorShaffer, Ren_US
dc.contributor.authorSheehan, Den_US
dc.contributor.authorSimms, Men_US
dc.contributor.authorSrihari, Nen_US
dc.contributor.authorStrebel, Ren_US
dc.contributor.authorSundar, Sen_US
dc.contributor.authorTolan, Sen_US
dc.contributor.authorTsang, Den_US
dc.contributor.authorVarughese, Men_US
dc.contributor.authorWagstaff, Jen_US
dc.contributor.authorParmar, MKBen_US
dc.contributor.authorJames, NDen_US
dc.contributor.authorSTAMPEDE Investigatorsen_US
dc.identifier.citationAnnals of oncology : official journal of the European Society for Medical Oncology, 2018, 29 (5), pp. 1235 - 1248en_US
dc.description.abstract<h4>Background</h4>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.<h4>Method</h4>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/m2 3-weekly×6 + prednisolone 10 mg daily; or SOC + abiraterone acetate 1000 mg + prednisolone 5 mg 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.<h4>Results</h4>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; prevalence 11% at 1 and 2 years on both arms. Relapse treatment patterns varied by arm.<h4>Conclusions</h4>This direct, randomised comparative analysis of two new treatment standards for hormone-naïve prostate cancer showed no evidence of a difference in overall or prostate cancer-specific survival, nor in other important outcomes such as symptomatic skeletal events. Worst toxicity grade over entire time on trial was similar but comprised different toxicities in line with the known properties of the drugs.<h4>Trial registration</h4> NCT00268476.en_US
dc.format.extent1235 - 1248en_US
dc.subjectSTAMPEDE Investigatorsen_US
dc.subjectProstatic Neoplasmsen_US
dc.subjectAndrogen Antagonistsen_US
dc.subjectProstate-Specific Antigenen_US
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen_US
dc.subjectDisease-Free Survivalen_US
dc.subjectFollow-Up Studiesen_US
dc.subjectKaplan-Meier Estimateen_US
dc.subjectStandard of Careen_US
dc.subjectAbiraterone Acetateen_US
dc.subjectNetwork Meta-Analysisen_US
dc.subjectProgression-Free Survivalen_US
dc.titleAdding abiraterone or docetaxel to long-term hormone therapy for prostate cancer: directly randomised data from the STAMPEDE multi-arm, multi-stage platform protocol.en_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfAnnals of oncology : official journal of the European Society for Medical Oncologyen_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Prostate Cancer Targeted Therapy Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams/Clinical Academic Radiotherapy (Dearnaley)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Treatment Resistance
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.embargo.termsNot knownen_US
icr.researchteamProstate Cancer Targeted Therapy Groupen_US
icr.researchteamClinical Academic Radiotherapy (Dearnaley)en_US
icr.researchteamTreatment Resistanceen_US
icr.researchteamProstate and Bladder Cancer Researchen_US
dc.contributor.icrauthorDearnaley, Daviden_US
dc.contributor.icrauthorDe Bono, Johannen_US
dc.contributor.icrauthorParker, Chrisen_US
dc.contributor.icrauthorAttard, Gerhardten_US
dc.contributor.icrauthorJames, Nicholasen_US

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