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Addition of celecoxib to HT did not benefit patients with high-risk prostate cancer
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The addition of celecoxib to hormone therapy in treatment of patients with high-risk prostate cancer offered no greater benefit than the use of hormone therapy alone, according to interim analysis results of the STAMPEDE trial.
The trial included 2,043 men who had newly diagnosed or rapidly relapsing prostate cancer and were about to start their first long-term hormone therapy treatment.
Patients were randomly assigned to one of six arms. One arm evaluated hormone therapy alone. The others tested the addition of zoledronic acid, docetaxel, celecoxib, docetaxel plus zoledronic acid, and celecoxib plus zoledronic acid.
The interim analysis compared men who were assigned hormone therapy alone (arm A; n=584) and those who received 400 mg celecoxib twice daily until 1 year or disease progression (arm D; n=291).
At the time of the interim analysis, 305 failure-free survival events had occurred (209 among patients assigned to hormone therapy alone, and 96 among patients assigned to celecoxib). The 2-year failure-free survival was 51% in both arms, indicating there was no advantage to adding celecoxib to hormone therapy alone.
The rate of adverse events was similar between the two arms. The most common grade-3 to grade-5 adverse events were endocrine disorders (11% of patients assigned to hormone therapy alone vs. 7% among those assigned to celecoxib) and musculoskeletal disorders (6% in both groups).
“Other trials in prostate cancer (and other cancer types) have not supported the use of COX-2 inhibitors unequivocally in any setting, and our trial adds further evidence of the limited clinical utility of these drugs in established, advanced cancer,” the researchers wrote. “We do not recommend their use in these patients.”
Perspective
Back to TopDonald L. Trump, MD
James and colleagues report a preplanned analysis of the second intermediate activity stage of the STAMPEDE trial, an innovative and complex trial that seeks to define whether there is benefit to adding other agents to standard androgen deprivation (AD) in men with metastatic or high-risk prostate cancer who are beginning long-term AD. This design allows the sequential evaluation of AD alone vs. the addition of celecoxib, zoledronic acid, docetaxel, docetaxel plus zoledronic acid, or celecoxib plus zoledronic acid. This preplanned analysis indicates that, although celecoxib did not add risk or toxicity to the use of AD alone, there was no indication of any benefit. The signal for added benefit — as defined in the protocol — was prolongation failure-free survival, which the authors acknowledge is a surrogate for OS. In the two celecoxib arms, treatment with celecoxib was discontinued and follow-up will continue to examine OS. Based on this well-designed, complex and rigorous trial, the preliminary suggestion that COX-2 inhibitors such as celecoxib plus AD may improve survival in men with advanced prostate cancer is not borne out and such therapy cannot be recommended.
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James ND. Lancet Oncol. 2012;doi:10.1016/S1470-2045(12)70088-8.
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