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Published on 11 December 2008

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First aromatase inhibitor to indicate survival after breast cancer surgery

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Femara® first aromatase inhibitor to indicate survival benefit versus tamoxifen when taken for five years after breast cancer surgery.

New long term data from a major international breast cancer study reports that postmenopausal woman with hormone receptor positive early stage breast cancer who took Femara (letrozole) for five years following surgery, had a 13% reduced risk of death, when compared with tamoxifen.

These results are from a protocol defined intent to treat (ITT) analysis (median follow-up of 76 months) of the Femara and tamoxifen monotherapy arms in the Breast International Group (BIG) 1-98 study.

The International Breast Cancer Study Group (IBCSG) presented these results from the BIG 1-98 trial 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.

“Femara has consistently demonstrated remarkable results and these data reaffirm the benefit of Femara for postmenopausal women with early-stage breast cancer,” said Alessandro Riva, MD, Executive Vice President, Head of Global Development at Novartis Oncology. “The survival data shown may offer new promise for breast cancer patients.”

Also presented at the meeting were results from the Sequential Treatment Analysis (STA) of BIG 1-98 that support the benefit of starting adjuvant treatment with five years of Femara after surgery. This analysis (from randomization) revealed that sequencing hormone therapy following surgery is not superior to five years of Femara alone.



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