dc.contributor.author | Hoyle, AP | |
dc.contributor.author | Ali, A | |
dc.contributor.author | James, ND | |
dc.contributor.author | Cook, A | |
dc.contributor.author | Parker, CC | |
dc.contributor.author | de Bono, JS | |
dc.contributor.author | Attard, G | |
dc.contributor.author | Chowdhury, S | |
dc.contributor.author | Cross, WR | |
dc.contributor.author | Dearnaley, DP | |
dc.contributor.author | Brawley, CD | |
dc.contributor.author | Gilson, C | |
dc.contributor.author | Ingleby, F | |
dc.contributor.author | Gillessen, S | |
dc.contributor.author | Aebersold, DM | |
dc.contributor.author | Jones, RJ | |
dc.contributor.author | Matheson, D | |
dc.contributor.author | Millman, R | |
dc.contributor.author | Mason, MD | |
dc.contributor.author | Ritchie, AWS | |
dc.contributor.author | Russell, M | |
dc.contributor.author | Douis, H | |
dc.contributor.author | Parmar, MKB | |
dc.contributor.author | Sydes, MR | |
dc.contributor.author | Clarke, NW | |
dc.contributor.author | STAMPEDE Investigators, | |
dc.date.accessioned | 2021-03-01T14:42:42Z | |
dc.date.available | 2021-03-01T14:42:42Z | |
dc.date.issued | 2019-12-01 | |
dc.identifier.citation | European urology, 2019, 76 (6), pp. 719 - 728 | |
dc.identifier.issn | 0302-2838 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/4379 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.doi | 10.1016/j.eururo.2019.08.006 | |
dc.description.abstract | BACKGROUND: Abiraterone acetate received licencing for use in only "high-risk" metastatic hormone-naïve prostate cancer (mHNPC) following the LATITUDE trial findings. However, a "risk"-related effect was not seen in the STAMPEDE trial. There remains uncertainty as to whether men with LATITUDE "low-risk" M1 disease benefit from androgen deprivation therapy (ADT) combined with abiraterone acetate and prednisolone (AAP). OBJECTIVE: Evaluation of heterogeneity of effect between LATITUDE high- and low-risk M1 prostate cancer patients receiving ADT + AAP in the STAMPEDE trial. DESIGN, SETTING, AND PARTICIPANTS: A post hoc subgroup analysis of the 2017 STAMPEDE "abiraterone comparison". Staging scans for M1 patients contemporaneously randomised to ADT or ADT + AAP within the STAMPEDE trial were evaluated centrally and blind to treatment assignment. Stratification was by risk according to the criteria set out in the LATITUDE trial. Exploratory subgroup stratification incorporated the CHAARTED criteria. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome measure was overall survival (OS) and the secondary outcome measure was failure-free survival (FFS). Further exploratory analysis evaluated clinical skeletal-related events, progression-free survival (PFS), and prostate cancer-specific death. Standard Cox-regression and Kaplan-Meier survival estimates were employed for analysis. RESULTS AND LIMITATIONS: A total of 901 M1 STAMPEDE patients were evaluated after exclusions. Of the patients, 428 (48%) were identified as having a low risk and 473 (52%) a high risk. Patients receiving ADT + AAP had significantly improved OS (low-risk hazard ratio [HR]: 0.66, 95% confidence interval or CI [0.44-0.98]) and FFS (low-risk HR: 0.24, 95% CI [0.17-0.33]) compared with ADT alone. Heterogeneity of effect was not seen between low- and high-risk groups for OS or FFS. For OS benefit in low risk, the number needed to treat was four times greater than that for high risk. However, this was not observed for the other measured endpoints. CONCLUSIONS: Men with mHNPC gain treatment benefit from ADT + AAP irrespective of risk stratification for "risk" or "volume". PATIENT SUMMARY: Coadministration of abiraterone acetate and prednisolone with androgen deprivation therapy (ADT) is associated with prolonged overall survival and disease control, compared with ADT alone, in all men with metastatic disease starting hormone therapy for the first time. | |
dc.format | Print-Electronic | |
dc.format.extent | 719 - 728 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER | |
dc.rights.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | STAMPEDE Investigators | |
dc.subject | Humans | |
dc.subject | Prostatic Neoplasms | |
dc.subject | Androstenes | |
dc.subject | Prednisone | |
dc.subject | Androgen Antagonists | |
dc.subject | Antineoplastic Agents, Hormonal | |
dc.subject | Drug Combinations | |
dc.subject | Risk Assessment | |
dc.subject | Retrospective Studies | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Male | |
dc.subject | Randomized Controlled Trials as Topic | |
dc.title | Abiraterone in "High-" and "Low-risk" Metastatic Hormone-sensitive Prostate Cancer. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2019-08-07 | |
rioxxterms.version | AM | |
rioxxterms.versionofrecord | 10.1016/j.eururo.2019.08.006 | |
rioxxterms.licenseref.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European urology | |
pubs.issue | 6 | |
pubs.notes | Not known | |
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/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.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/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.publication-status | Published | |
pubs.volume | 76 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Prostate Cancer Targeted Therapy Group | |
icr.researchteam | Clinical Academic Radiotherapy (Dearnaley) | |
icr.researchteam | Treatment Resistance | |
icr.researchteam | Prostate and Bladder Cancer Research | |
icr.researchteam | Prostate Cancer Targeted Therapy Group | |
icr.researchteam | Clinical Academic Radiotherapy (Dearnaley) | |
icr.researchteam | Treatment Resistance | |
icr.researchteam | Prostate and Bladder Cancer Research | |
dc.contributor.icrauthor | James, Nicholas | |
dc.contributor.icrauthor | De Bono, Johann | |
dc.contributor.icrauthor | Dearnaley, David | |