Pfizer announced results from a first planned analysis of the TEAM (Tamoxifen, Exemestane, Adjuvant, Multicenter) trial. TEAM was originally designed in 2001 as a comparison of five years of upfront Aromasin (exemestane tablets) vs. tamoxifen. In 2004, based on results of Intergroup Exemestane Study (IES) the TEAM trial design was revised; the tamoxifen arm was converted into a tamoxifen/Aromasin sequencing arm. This analysis presented at SABCS 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 (DFS: disease progression or death) at 2.75 years in 9,775 patients randomized to initial therapy with either tamoxifen or Aromasin.
The analysis of DFS at 2.75 years demonstrated an 11 percent reduction in the risk of DFS events in favour 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. Results from TEAM trial sub-studies were also presented at SABCS.
"The TEAM data contribute to the growing knowledge of the role of aromatase inhibitors in the treatment of early breast cancer," said Dr Steve Jones, medical director, US Oncology Research, Houston and Texas Oncology, Dallas, TX. "Clinicians take into account patient profile, clinical evidence and guidelines when determining the optimal treatment regimen for patients, and should consider these new data as treatment strategies are evaluated."
Aromasin is the only aromatase inhibitor indicated for sequential therapy in postmenopausal women with HR positive early breast cancer after two to three years of tamoxifen for a total of five years of adjuvant therapy. The use of Aromasin in this setting is supported by the landmark IES trial. Aromasin is also indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.