Celecoxib or Celecoxib/Zoledronic Acid in Men Initiating Hormone Therapy for Prostate Cancer
As reported by Mason et al in the Journal of Clinical Oncology, long-term survival results of the UK-based, multiarm, multistage platform–design STAMPEDE trial showed no survival benefit with the addition of celecoxib or celecoxib plus zoledronic acid in men initiating long-term hormone therapy for high-risk locally advanced or metastatic prostate cancer. Accrual to the two celecoxib-containing arms was stopped early after interim analysis showed insufficient effect on failure-free survival.
Study Details
In the trial, 1,245 men were randomized 2:1:1 between October 2005 and April 2011 to receive standard of care consisting of hormone therapy given continuously for metastatic disease or for at least 2 years for nonmetastatic disease (n = 622), standard of care plus celecoxib at 400 mg twice a day for 1 year (n = 312), or standard of care plus celecoxib and zoledronic acid at 4 mg for six 3-weekly cycles and then every 4 weeks for 2 years (n = 311). Overall, 61% of patients had metastatic disease.
Survival Outcomes
Median follow-up was 69 months. Median overall survival was 66 months in the standard of care group, 70 months in the standard of care plus celecoxib group (adjusted hazard ratio [HR] vs standard of care = 0.98, P = .847), and 76 months in the standard of care plus celecoxib plus zoledronic acid group (adjusted HR vs standard of care = 0.86, P =.130).
A preplanned subgroup analysis in patients with metastatic disease showed a hazard ratio of 0.78 (P = .033) for standard of care plus celecoxib and zoledronic acid vs standard of care.
Grade ≥ 3 adverse events occurred in 36% of the standard of care group, 33% of the standard of care plus celecoxib group, and 32% of the standard of care plus celecoxib and zoledronic acid group.
The investigators concluded: “Our data show no evidence of a survival advantage in adding [celecoxib] alone for all men starting long-term [hormone therapy] for the first time. We previously also showed no evidence of a survival advantage in adding [zoledronic acid] alone for the same patient group. Overall, the combination of [celecoxib] and [zoledronic acid] had no effect. Preplanned subgroup analyses may provide a hypothesis for future studies to investigate adding [celecoxib] in settings in which [zoledronic acid] is already part of the [standard of care].”
The study was supported by Cancer Research UK, the Medical Research Council, Novartis, Sanofi, Pfizer, Janssen Pharmaceuticals, Astellas Pharma, the National Institute of Health Research Clinical Research Network (formerly the National Cancer Research Network), and the Swiss Group for Clinical Cancer Research.
Matthew R. Sydes, MSc, of the MRC Clinical Trials Unit at University College London, is the corresponding author of the Journal of Clinical Oncology article.
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