dc.contributor.author | Mason, MD | |
dc.contributor.author | Clarke, NW | |
dc.contributor.author | James, ND | |
dc.contributor.author | Dearnaley, DP | |
dc.contributor.author | Spears, MR | |
dc.contributor.author | Ritchie, AWS | |
dc.contributor.author | Attard, G | |
dc.contributor.author | Cross, W | |
dc.contributor.author | Jones, RJ | |
dc.contributor.author | Parker, CC | |
dc.contributor.author | Russell, JM | |
dc.contributor.author | Thalmann, GN | |
dc.contributor.author | Schiavone, F | |
dc.contributor.author | Cassoly, E | |
dc.contributor.author | Matheson, D | |
dc.contributor.author | Millman, R | |
dc.contributor.author | Rentsch, CA | |
dc.contributor.author | Barber, J | |
dc.contributor.author | Gilson, C | |
dc.contributor.author | Ibrahim, A | |
dc.contributor.author | Logue, J | |
dc.contributor.author | Lydon, A | |
dc.contributor.author | Nikapota, AD | |
dc.contributor.author | O'Sullivan, JM | |
dc.contributor.author | Porfiri, E | |
dc.contributor.author | Protheroe, A | |
dc.contributor.author | Srihari, NN | |
dc.contributor.author | Tsang, D | |
dc.contributor.author | Wagstaff, J | |
dc.contributor.author | Wallace, J | |
dc.contributor.author | Walmsley, C | |
dc.contributor.author | Parmar, MKB | |
dc.contributor.author | Sydes, MR | |
dc.contributor.author | STAMPEDE Investigators, | |
dc.date.accessioned | 2017-04-03T09:57:27Z | |
dc.date.issued | 2017-05-10 | |
dc.identifier.citation | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017, 35 (14), pp. 1530 - 1541 | |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/545 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/jco.2016.69.0677 | |
dc.description.abstract | Purpose Systemic Therapy for Advanced or Metastatic Prostate Cancer: Evaluation of Drug Efficacy is a randomized controlled trial using a multiarm, multistage, platform design. It recruits men with high-risk, locally advanced or metastatic prostate cancer who were initiating long-term hormone therapy. We report survival data for two celecoxib (Cel)-containing comparisons, which stopped accrual early at interim analysis on the basis of failure-free survival. Patients and Methods Standard of care (SOC) was hormone therapy continuously (metastatic) or for ≥ 2 years (nonmetastatic); prostate (± pelvic node) radiotherapy was encouraged for men without metastases. Cel 400 mg was administered twice a day for 1 year. Zoledronic acid (ZA) 4 mg was administered for six 3-weekly cycles, then 4-weekly for 2 years. Stratified random assignment allocated patients 2:1:1 to SOC (control), SOC + Cel, or SOC + ZA + Cel. The primary outcome measure was all-cause mortality. Results were analyzed with Cox proportional hazards and flexible parametric models adjusted for stratification factors. Results A total of 1,245 men were randomly assigned (Oct 2005 to April 2011). Groups were balanced: median age, 65 years; 61% metastatic, 14% N+/X M0, 25% N0M0; 94% newly diagnosed; median prostate-specific antigen, 66 ng/mL. Median follow-up was 69 months. Grade 3 to 5 adverse events were seen in 36% SOC-only, 33% SOC + Cel, and 32% SOC + ZA + Cel patients. There were 303 control arm deaths (83% prostate cancer), and median survival was 66 months. Compared with SOC, the adjusted hazard ratio was 0.98 (95% CI, 0.80 to 1.20; P = .847; median survival, 70 months) for SOC + Cel and 0.86 (95% CI, 0.70 to 1.05; P =.130; median survival, 76 months) for SOC + ZA + Cel. Preplanned subgroup analyses in men with metastatic disease showed a hazard ratio of 0.78 (95% CI, 0.62 to 0.98; P = .033) for SOC + ZA + Cel. Conclusion These data show no overall evidence of improved survival with Cel. Preplanned subgroup analyses provide hypotheses for future studies. | |
dc.format | Print-Electronic | |
dc.format.extent | 1530 - 1541 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | AMER SOC CLINICAL ONCOLOGY | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | STAMPEDE Investigators | |
dc.subject | Humans | |
dc.subject | Prostatic Neoplasms | |
dc.subject | Lymphatic Metastasis | |
dc.subject | Diphosphonates | |
dc.subject | Imidazoles | |
dc.subject | Prostate-Specific Antigen | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Disease-Free Survival | |
dc.subject | Orchiectomy | |
dc.subject | Cause of Death | |
dc.subject | Survival Rate | |
dc.subject | Proportional Hazards Models | |
dc.subject | Follow-Up Studies | |
dc.subject | Time Factors | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Male | |
dc.subject | Gonadotropin-Releasing Hormone | |
dc.subject | Early Termination of Clinical Trials | |
dc.subject | Celecoxib | |
dc.subject | Zoledronic Acid | |
dc.title | Adding Celecoxib With or Without Zoledronic Acid for Hormone-Naïve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2017-03-13 | |
rioxxterms.versionofrecord | 10.1200/jco.2016.69.0677 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2017-05 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Journal of clinical oncology : official journal of the American Society of Clinical Oncology | |
pubs.issue | 14 | |
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/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/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 | 35 | |
pubs.embargo.terms | Not known | |
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 | Dearnaley, David | |