In 2004, based on results of Intergroup Exemestane Study the Team trial design was revised; the tamoxifen arm was converted into a tamoxifen/Aromasin sequencing arm. This analysis represents the first of two co-primary endpoints that will be reported from this trial.
The first co-primary endpoint compares early events by measuring disease-free survival at 2.75 years in 9,775 patients randomized to initial therapy with either tamoxifen or Aromasin.
According to the company, the analysis of disease-free survival (DFS) at 2.75 years demonstrated an 11% reduction in the risk of DFS events in favor of Aromasin (HR=0.89; 95% CI, 0.77-1.03). This difference was not statistically significant (p=0.118). A second planned analysis of DFS after five years of therapy is expected in late 2009.
Additional secondary analyses demonstrated a 15% reduction in the risk of recurrence-free survival events in favor of Aromasin (HR=0.85; 95% CI, 0.72-1.00; p=0.049) and 19% improvement in the time-to-distant metastasis in favor of Aromasin (HR=0.81; 95% CI, 0.67-0.98; p=0.026), the company said.
Ray Urbanski, senior medical director/oncology group lead at Pfizer, said: “Aromasin has had an important impact on the treatment of women with breast cancer since its approval. We are proud of our heritage in breast cancer, and continued commitment to develop new treatment options to meet the unmet needs of these patients.”