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dc.contributor.authorMason, M
dc.contributor.authorClarke, Noel W
dc.contributor.authorJames, N
dc.contributor.authorDearnaley, D
dc.contributor.authorSpears, M
dc.contributor.authorRitchie, A
dc.contributor.authorAttard, G
dc.contributor.authorCross, W
dc.contributor.authorJones, R
dc.contributor.authorParker, C
dc.contributor.authorRussell, J
dc.contributor.authorThalmann, G
dc.contributor.authorSchiavone, F
dc.contributor.authorCassoly, E
dc.contributor.authorMatheson, D
dc.contributor.authorMillman, R
dc.contributor.authorRentsch, C
dc.contributor.authorBarber, J
dc.contributor.authorGilson, C
dc.contributor.authorIbrahim, A
dc.contributor.authorLogue, John P
dc.contributor.authorLydon, A
dc.contributor.authorNikapota, A
dc.contributor.authorO'Sullivan, J
dc.contributor.authorPorfiri, E
dc.contributor.authorProtheroe, A
dc.contributor.authorSrihari, N
dc.contributor.authorTsang, D
dc.contributor.authorWagstaff, J
dc.contributor.authorWallace, J
dc.contributor.authorWalmsley, C
dc.contributor.authorParmar, M
dc.contributor.authorSydes, M
dc.date.accessioned2017-05-02T20:29:41Z
dc.date.available2017-05-02T20:29:41Z
dc.date.issued2017-03-13
dc.identifier.citationAdding celecoxib with or without zoledronic acid for hormone-naïve prostate cancer: long-term survival results from an adaptive, multiarm, multistage, platform, randomized controlled trial. 2017, J Clin Oncolen
dc.identifier.issn1527-7755
dc.identifier.pmid28300506
dc.identifier.doi10.1200/JCO.2016.69.0677
dc.identifier.urihttp://hdl.handle.net/10541/620323
dc.description.abstractPurpose 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.language.isoenen
dc.rightsArchived with thanks to Journal of clinical oncology : official journal of the American Society of Clinical Oncologyen
dc.titleAdding celecoxib with or without zoledronic acid for hormone-naïve prostate cancer: long-term survival results from an adaptive, multiarm, multistage, platform, randomized controlled trial.en
dc.typeArticleen
dc.contributor.departmentCardiff University School of Medicine, Velindre Hospital, Cardiffen
dc.identifier.journalJournal of Clinical Oncologyen
refterms.dateFOA2018-12-17T14:54:44Z
html.description.abstractPurpose 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.


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