dc.contributor.author | James, ND | |
dc.contributor.author | Ingleby, FC | |
dc.contributor.author | Clarke, NW | |
dc.contributor.author | Amos, CL | |
dc.contributor.author | Attard, G | |
dc.contributor.author | Brawley, CD | |
dc.contributor.author | Chowdhury, S | |
dc.contributor.author | Cross, W | |
dc.contributor.author | Dearnaley, DP | |
dc.contributor.author | Gilbert, DC | |
dc.contributor.author | Gillessen, S | |
dc.contributor.author | Jones, RJ | |
dc.contributor.author | Langley, RE | |
dc.contributor.author | Macnair, A | |
dc.contributor.author | Malik, ZI | |
dc.contributor.author | Mason, MD | |
dc.contributor.author | Matheson, DJ | |
dc.contributor.author | Millman, R | |
dc.contributor.author | Parker, CC | |
dc.contributor.author | Rush, HL | |
dc.contributor.author | Russell, JM | |
dc.contributor.author | Au, C | |
dc.contributor.author | Ritchie, AWS | |
dc.contributor.author | Mestre, RP | |
dc.contributor.author | Ahmed, I | |
dc.contributor.author | Birtle, AJ | |
dc.contributor.author | Brock, SJ | |
dc.contributor.author | Das, P | |
dc.contributor.author | Ford, VA | |
dc.contributor.author | Gray, EK | |
dc.contributor.author | Hughes, RJ | |
dc.contributor.author | Manetta, CB | |
dc.contributor.author | McLaren, DB | |
dc.contributor.author | Nikapota, AD | |
dc.contributor.author | O'Sullivan, JM | |
dc.contributor.author | Perna, C | |
dc.contributor.author | Peedell, C | |
dc.contributor.author | Protheroe, AS | |
dc.contributor.author | Sundar, S | |
dc.contributor.author | Tanguay, JS | |
dc.contributor.author | Tolan, SP | |
dc.contributor.author | Wagstaff, J | |
dc.contributor.author | Wallace, JB | |
dc.contributor.author | Wylie, JP | |
dc.contributor.author | Zarkar, A | |
dc.contributor.author | Parmar, MKB | |
dc.contributor.author | Sydes, MR | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2022-09-20T09:31:35Z | |
dc.date.available | 2022-09-20T09:31:35Z | |
dc.date.issued | 2022-07-01 | |
dc.identifier | ARTN pkac043 | |
dc.identifier | 6649740 | |
dc.identifier.citation | JNCI Cancer Spectrum, 2022, 6 (4), pp. pkac043 - | |
dc.identifier.issn | 2515-5091 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5498 | |
dc.identifier.eissn | 2515-5091 | |
dc.identifier.eissn | 2515-5091 | |
dc.identifier.doi | 10.1093/jncics/pkac043 | |
dc.description.abstract | BACKGROUND: 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 | Print | |
dc.format.extent | pkac043 - | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | OXFORD UNIV PRESS | |
dc.relation.ispartof | JNCI Cancer Spectrum | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | |
dc.subject | Androgen Antagonists | |
dc.subject | Androgens | |
dc.subject | Docetaxel | |
dc.subject | Humans | |
dc.subject | Male | |
dc.subject | Prostate-Specific Antigen | |
dc.subject | Prostatic Neoplasms | |
dc.title | Docetaxel for Nonmetastatic Prostate Cancer: Long-Term Survival Outcomes in the STAMPEDE Randomized Controlled Trial. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-02-24 | |
dc.date.updated | 2022-09-20T09:30:57Z | |
rioxxterms.version | VoR | |
rioxxterms.versionofrecord | 10.1093/jncics/pkac043 | |
rioxxterms.licenseref.startdate | 2022-07-01 | |
rioxxterms.type | Journal Article/Review | |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/35877084 | |
pubs.issue | 4 | |
pubs.organisational-group | /ICR | |
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) | |
pubs.organisational-group | /ICR/ImmNet | |
pubs.publication-status | Published | |
pubs.publisher-url | http://dx.doi.org/10.1093/jncics/pkac043 | |
pubs.volume | 6 | |
icr.researchteam | Prostate & Bladder Cancer | |
icr.researchteam | Clinic Acad RT Dearnaley | |
dc.contributor.icrauthor | James, Nicholas | |
dc.contributor.icrauthor | Dearnaley, David | |
icr.provenance | Deposited 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 | |