The primary outcome of the trial was disease-free survival (DFS), which was defined as the time from randomization to the date of diagnosis of first local or distant metastasis at any site; second primary BC; or death from any cause after the 2 years of adjuvant therapy with celecoxib. A secondary endpoint was overall survival (OS), which referred to time from randomization to death from any cause; toxic effects from celecoxib with long-term use of celecoxib in patients with primary BC; cardiovascular mortality; and incidence of secondary primary cancers.
A total of 2,639 women were enrolled in the study, of whom 1,763 received celecoxib and 876 received placebo. At the conclusion of the trial, the overall median follow-up was 74.3 months. The median age of the study population was 55.2 years, and 69% were postmenopausal at the time of study initiation. Approximately three-quarters of patients in both the celecoxib and placebo groups were estrogen (ER+) or progesterone-receptor (PR+) positive and ERBB2-receptor negative (ERBB2-). One-half of patients in both the celecoxib and placebo groups had node-positive disease, with 42% of patients in both groups having grade 3 tumors. About two-thirds of patients with ER+ disease in both treatment groups and virtually all (99%) patients with estrogen receptor-negative (ER-) disease received cytotoxic chemotherapy.
The investigators found that 18% of patients in the celecoxib group and 19% of those in the placebo group experienced a DFS event, with a 5-year DFS rate of 84% and 83%, respectively; this was not a statistically significant difference. There were no differences in DFS between the celecoxib and placebo groups when ER status, menopausal status, nodal involvement, and chemotherapy administration were taken into account.
There were also no differences in OS between the two groups, with 5-year OS of 90% in the celecoxib group and 91% in the placebo group. ER status had no effect on this finding.
The researchers did not find any differences between the occurrence of prespecified cardiovascular events (i.e., myocardial infarction, heart failure, coronary heart disease, hypertension, cardiac-rhythm abnormalities, peripheral vascular disease, stroke, or carotid disease) or for any gastrointestinal adverse events. There also was no interaction between cyclooxygenase-2 status (low vs. high expression) and study endpoints.
This paper provides pharmacists with valuable information on the lack of efficacy of celecoxib for BC while at the same time assuring them of the safety of the use of this NSAIA.
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