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dc.contributor.authorJames, ND
dc.contributor.authorIngleby, FC
dc.contributor.authorClarke, NW
dc.contributor.authorAmos, CL
dc.contributor.authorAttard, G
dc.contributor.authorBrawley, CD
dc.contributor.authorChowdhury, S
dc.contributor.authorCross, W
dc.contributor.authorDearnaley, DP
dc.contributor.authorGilbert, DC
dc.contributor.authorGillessen, S
dc.contributor.authorJones, RJ
dc.contributor.authorLangley, RE
dc.contributor.authorMacnair, A
dc.contributor.authorMalik, ZI
dc.contributor.authorMason, MD
dc.contributor.authorMatheson, DJ
dc.contributor.authorMillman, R
dc.contributor.authorParker, CC
dc.contributor.authorRush, HL
dc.contributor.authorRussell, JM
dc.contributor.authorAu, C
dc.contributor.authorRitchie, AWS
dc.contributor.authorMestre, RP
dc.contributor.authorAhmed, I
dc.contributor.authorBirtle, AJ
dc.contributor.authorBrock, SJ
dc.contributor.authorDas, P
dc.contributor.authorFord, VA
dc.contributor.authorGray, EK
dc.contributor.authorHughes, RJ
dc.contributor.authorManetta, CB
dc.contributor.authorMcLaren, DB
dc.contributor.authorNikapota, AD
dc.contributor.authorO'Sullivan, JM
dc.contributor.authorPerna, C
dc.contributor.authorPeedell, C
dc.contributor.authorProtheroe, AS
dc.contributor.authorSundar, S
dc.contributor.authorTanguay, JS
dc.contributor.authorTolan, SP
dc.contributor.authorWagstaff, J
dc.contributor.authorWallace, JB
dc.contributor.authorWylie, JP
dc.contributor.authorZarkar, A
dc.contributor.authorParmar, MKB
dc.contributor.authorSydes, MR
dc.identifierARTN pkac043
dc.identifier.citationJNCI Cancer Spectrum, 2022, 6 (4), pp. pkac043 -en_US
dc.description.abstractBACKGROUND: STAMPEDE previously reported adding upfront docetaxel improved overall survival for prostate cancer patients starting long-term androgen deprivation therapy. We report long-term results for non-metastatic patients using, as primary outcome, metastatic progression-free survival (mPFS), an externally demonstrated surrogate for overall survival. METHODS: Standard of care (SOC) was androgen deprivation therapy with or without radical prostate radiotherapy. A total of 460 SOC and 230 SOC plus docetaxel were randomly assigned 2:1. Standard survival methods and intention to treat were used. Treatment effect estimates were summarized from adjusted Cox regression models, switching to restricted mean survival time if non-proportional hazards. mPFS (new metastases, skeletal-related events, or prostate cancer death) had 70% power (α = 0.05) for a hazard ratio (HR) of 0.70. Secondary outcome measures included overall survival, failure-free survival (FFS), and progression-free survival (PFS: mPFS, locoregional progression). RESULTS: Median follow-up was 6.5 years with 142 mPFS events on SOC (3 year and 54% increases over previous report). There was no good evidence of an advantage to SOC plus docetaxel on mPFS (HR = 0.89, 95% confidence interval [CI] = 0.66 to 1.19; P = .43); with 5-year mPFS 82% (95% CI = 78% to 87%) SOC plus docetaxel vs 77% (95% CI = 73% to 81%) SOC. Secondary outcomes showed evidence SOC plus docetaxel improved FFS (HR = 0.70, 95% CI = 0.55 to 0.88; P = .002) and PFS (nonproportional P = .03, restricted mean survival time difference = 5.8 months, 95% CI = 0.5 to 11.2; P = .03) but no good evidence of overall survival benefit (125 SOC deaths; HR = 0.88, 95% CI = 0.64 to 1.21; P = .44). There was no evidence SOC plus docetaxel increased late toxicity: post 1 year, 29% SOC and 30% SOC plus docetaxel grade 3-5 toxicity. CONCLUSIONS: There is robust evidence that SOC plus docetaxel improved FFS and PFS (previously shown to increase quality-adjusted life-years), without excess late toxicity, which did not translate into benefit for longer-term outcomes. This may influence patient management in individual cases.
dc.format.extentpkac043 -
dc.publisherOXFORD UNIV PRESSen_US
dc.relation.ispartofJNCI Cancer Spectrum
dc.subjectAndrogen Antagonists
dc.subjectProstate-Specific Antigen
dc.subjectProstatic Neoplasms
dc.titleDocetaxel for Nonmetastatic Prostate Cancer: Long-Term Survival Outcomes in the STAMPEDE Randomized Controlled Trial.en_US
dc.typeJournal Article
rioxxterms.typeJournal Article/Reviewen_US
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Prostate and Bladder Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Closed research teams/Clinical Academic Radiotherapy (Dearnaley)
icr.researchteamProstate & Bladder Canceren_US
icr.researchteamClinic Acad RT Dearnaleyen_US
dc.contributor.icrauthorJames, Nicholas
dc.contributor.icrauthorDearnaley, David
dc.contributor.icrauthorParker, Chris
icr.provenanceDeposited by Mr Arek Surman (impersonating Dr Amit Sud) on 2022-09-20. Deposit type is initial. No. of files: 1. Files: Docetaxel for Nonmetastatic Prostate Cancer Long-Term Survival Outcomes in the STAMPEDE Randomized Controlled Trial.pdf

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