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Celecoxib policy brief.indd

Briefing Paper
March 2012
Issue 4
Celecoxib does not improve
failure-free survival for hormone-
sensitive prostate cancer

measurable tissue levels. A study by Smith tested Celecoxib
Prostate cancer is a major health problem. inflammatory drug (NSAID), and a selective Cyclooxygenase-2 (Cox-2) inhibitor. There The STAMPEDE trial is the biggest trial of therapy is the current standard treatment are several reasons why it was thought that for locally-advanced or metastatic prostate results to date. There is more information cancer, usually using drugs. 95% of patients survival for men with metastatic or high-risk respond to hormone therapy, but it is not non-metastatic prostate cancer. Cox-2 is a cure. The disease recurs in nearly every associated with carcinogenesis. Pathological Key points
prostate carcinoma. Case-control studies There has been a lot of attention for years, and particularly recently, on the cancer prostate cancer. There is also some evidence prevention role of aspirin and other non- steroidal anti-inflammatory drugs (NSAIDs). from sub-clinical to clinical prostate cancer. This, together with the evidence of aspirin’s the risk of various cancers, when taken as effectiveness at preventing various cancers, prophylaxis. Aspirin may also reduce the provided a rationale for testing an NSAID risk of distant metastases. The STAMPEDE Cox-2 inhibitor for treating prostate cancer. trial set out to test the hypothesis that Celecoxib was chosen as it was likely to targeting COX-2 (see below) may underpin the observed effects seen both with aspirin Does celecoxib improve
outcomes of men with
timely given the important further data on metastatic or high-risk non-
the role of aspirin in cancer prevention. metastatic prostate cancer?
This briefing paper looks at the results Clinical trials of Cox-2 inhibitors have had of part of the STAMPEDE trial, assessing mixed results in many established cancers, whether the addition of celecoxib (another Antonarakis et al. of 64 men with localised outcomes for men with prostate cancer.
prostate carcinogenesis, despite achieving MRC CTU Briefing Paper, March 2012, Issue 4 | pg. 1
Failure-free survival is
The STAMPEDE trial aims to try to prevent prostate cancer tumour re- growth by adding additional treatment to standard hormone therapy. It has an innovative multi-arm, multi-stage design. This allows many promising drugs (or other treatments) to be simultaneously compared against a common control arm. The activity of each research arm is periodically assessed. Arms that fail to meet pre-specified activity of the trial was halted after the planned second intermediate targets, or are excessively toxic, are closed to new accrual.
analysis (about 5 years into the trial), as there was no evidence of the addition of celecoxib to hormone therapy leading to The STAMPEDE trial started late in 2005, testing the addition of zoledronic any benefit. The 24 month estimate of failure-free survival acid, docetaxel, celecoxib or combinations of these drugs to hormone was 51% in both arms. There was no evidence of differences therapy. The celecoxib arm stopped recruitment because of lack of benefit. in toxicity or adverse events with or without celecoxib.
The celecoxib + zoledronic acid arm also stopped accrual at the same time. These results are very timely, given the recent publication Coincidentally, a new arm, testing abiraterone, started recruiting of (and press interest in) several papers on the role of aspirin late in 2011. Further new arms may be added in the future.
in secondary prevention of cancer. These interim results indicate that celecoxib does not seem to be a good way Accrual + follow-up
of tapping in to this secondary prevention mechanism. Accrual + follow-up
It is expected that any benefit in overall survival would be preceded by a benefit in failure-free survival, but that a benefit Accrual + follow-up
in failure-free survival would not necessarily lead to a benefit in Follow-up (Apr-2011)
overall survival. Not enough time has passed to tell if celecoxib will lead to overall survival benefits. Celecoxib is not linked Accrual + follow-up
to androgens and so may not affect PSA-based measures of failure-free survival. The STAMPEDE trial will continue Follow-up only (Apr-2011)
long-term follow-up of patients to see if an overall survival benefit does emerge, but the researchers do not expect this.
Accrual + follow-up (Nov-2011)
Celecoxib at 400mg twice a day
The multi-arm, multi-stage method
The STAMPEDE trial is an innovative,
These are interim results based
Recommended reading
James, N. D., M. R. Sydes, et al. (2012). “Celecoxib plus hormone Sydes, M. R., N. D. James, et al. (2011). “Flexible trial design in therapy vs hormone therapy alone for hormone-sensitive practice - dropping and adding arms in STAMPEDE: a multi-arm prostate cancer: first results from STAMPEDE (NCT00268476) multi-stage randomised controlled trial.” Trials 12 Suppl 1: A3.
a multi-arm multi-stage randomised controlled trial” Lancet Oncology 13(4) doi:10.1016/S1470-2045(12)70088-8.
James, N. D., M. R. Sydes, et al. (2008). “STAMPEDE: Systemic Therapy for Advancing or Metastatic Prostate Cancer- a multi-arm multi-stage randomised controlled trial.” Clin Oncol (R Coll Radiol) 20(8): 577-581.
This briefing paper was written by Annabelle South, Matthew Sydes and Nicholas James, for the STAMPEDE investigators.
This document is an output from the STAMPEDE trial, which is funded by Cancer Research UK, Janssen, Novartis, Sanofi-Aventis, Pfizer and the Medical Research Council.
MRC CTU Briefing Paper, March 2012, Issue 4 | pg. 2


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