James ND. Lancet Oncol. 2012;doi:10.1016/S1470-2045(12)70088-8.
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.”