1: Celecoxib does not improve survival for men with advanced or metastatic prostate cancer
The STAMPEDE trial is a large multiarm, multistage, randomised controlled trial that is testing if combining hormone therapy with drugs or radiotherapy improves survival for men with advanced or metastatic prostate cancer. We previously described exciting results from this trial, that showed that adding docetaxel to hormone therapy (standard of care (SOC)) increased survival by an average of 10 months over SOC alone. Two additional arms have now published in the Journal of Clinical Oncology: SOC + Celecoxib (Cel) with or without Zoledronic Acid (ZA). Due to lack of evidence of improved survival within the trial, Cel use was discontinued early, although patient follow up continued as planned. Men were followed for a median of 5.8 years and there was no evidence that 5 year survival was improved by the addition of Cel or Cel + ZA to SOC (5 year survival 54%, 59% and 53% respectively). Previous analysis also failed to show any survival benefit of adding ZA alone to SOC. Interestingly, subgroup analyses for patients with metastatic disease (M1) suggested that men who received Cel + ZA + SOC had a decreased risk of death (HR, 0.78; p=0.03) compared to men on SOC alone, as well as improved 5 year survival (47% vs 37%). These data were not sufficiently powered to provide conclusive evidence, however they indicate that it may be worthwhile studying hormone therapy in combination with Celecoxib and Zoledronic Acid in a future clinical trial.