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Video: Femara(R) First Aromatase Inhibitor to Indicate Survival Benefit Versus Tamoxifen When Taken for Five Years After Breast Cancer Surgery
Date:12/11/2008

sented these results from the BIG 1-98 trial today at the 31st Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), an international scientific symposium for scientists and clinicians in breast cancer.

"These data represent an important milestone in the treatment of women with breast cancer. For the first time, we are seeing suggested survival benefit with aromatase inhibitor therapy for five years compared with tamoxifen for the same time period," said Henning T. Mouridsen, MD, PhD, Professor of Oncology, Copenhagen University Hospital and one of the investigators of the BIG 1-98 trial. "The potential reduction in the risk of death that we are seeing with letrozole in the adjuvant setting may be a positive result of letrozole's early and sustained reduction in the risk of recurrence and distant metastases."

BIG 1-98 is the only clinical trial designed to explore both a head-to-head comparison of an aromatase inhibitor with tamoxifen during the first five years following breast cancer surgery and the sequencing of both agents to determine the most effective approach to minimizing the risk of recurrence. In the initial adjuvant setting, Femara is the only aromatase inhibitor to have demonstrated an early significant reduction in distant metastases versus tamoxifen, at a median duration of follow-up of 26 months.

Beyond the potential survival benefit of 13% (P=0.08, HR=0.87, 95% CI: 0.75-1.02) reduction in risk of death for Femara patients seen in the ITT analysis, Femara demonstrated significant long-term benefit in reducing the risk of disease-free survival events by 12% (P=0.03, HR=0.88, 95% CI: 0.78-0.99) and reducing the risk of distant metastases by 15% (P=0.05, HR=0.85, 95% CI: 0.72-1.00) compared with tamoxifen.

"Femara has consistently demonstrated remarkable results and these data reaffirm the benefit of Femara for postmenopausal women with early-stage bre
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SOURCE Novartis Pharmaceuticals Corporation
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