{"id":4427,"date":"2017-06-13T09:32:42","date_gmt":"2017-06-13T09:32:42","guid":{"rendered":"http:\/\/www.library.sath.nhs.uk\/research\/?p=4427"},"modified":"2017-06-30T09:37:09","modified_gmt":"2017-06-30T09:37:09","slug":"adding-celecoxib-with-or-without-zoledronic-acid-for-hormone-naive-prostate-cancer-long-term-survival-results-from-an-adaptive-multiarm-multistage-platform-randomized-controlled-trial-2017","status":"publish","type":"post","link":"https:\/\/www.library.sath.nhs.uk\/research\/2017\/06\/13\/adding-celecoxib-with-or-without-zoledronic-acid-for-hormone-naive-prostate-cancer-long-term-survival-results-from-an-adaptive-multiarm-multistage-platform-randomized-controlled-trial-2017\/","title":{"rendered":"Adding Celecoxib With or Without Zoledronic Acid for Hormone-Na\u00efve Prostate Cancer: Long-Term Survival Results From an Adaptive, Multiarm, Multistage, Platform, Randomized Controlled Trial (2017)"},"content":{"rendered":"

Type of publication:<\/strong>
\nRandomised controlled trial<\/p>\n

Author(s):<\/strong>
\nMason, Malcolm D; Clarke, Noel W; James, Nicholas D; Dearnaley, David P; Spears, Melissa R; Ritchie, Alastair W S; Attard, Gerhardt; Cross, William; Jones, Rob J; Parker, Christopher C; Russell, J Martin; Thalmann, George N; Schiavone, Francesca; Cassoly, Estelle; Matheson, David; Millman, Robin; Rentsch, Cyrill A; Barber, Jim; Gilson, Clare; Ibrahim, Azman; Logue, John; Lydon, Anna; Nikapota, Ashok D; O'Sullivan, Joe M; Porfiri, Emilio; Protheroe, Andrew; *Srihari, Narayanan Nair; Tsang, David; Wagstaff, John; Wallace, Jan; Walmsley, Catherine; Parmar, Mahesh K B; Sydes, Matthew R; STAMPEDE Investigators<\/p>\n

Citation:<\/strong>
\nJournal of clinical oncology : official journal of the American Society of Clinical Oncology; 35, no. 14 (May 2017) p. 1530-1541.<\/p>\n

Abstract:<\/strong>
\nPurpose 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 \u2265 2 years (nonmetastatic); prostate (\u00b1 pelvic node) radiotherapy was encouraged for men\u00a0without 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\u00a0were 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\u00a0to 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.<\/p>\n

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