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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

- Femara showed reduced risk of death by 13% (P=0.08), despite inclusion of patients crossing over from tamoxifen to Femara therapy

- In a separate censored analysis excluding patients after they crossed over to Femara, reduction in risk of death was 19%

- Long-term follow-up from major independent BIG 1-98 trial reinforces starting with Femara as the optimal treatment strategy versus tamoxifen

EAST HANOVER, N.J., Dec. 11 /PRNewswire/ -- 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(R) (letrozole tablets) for five years following surgery had a 13% (P=0.08) reduced risk of death, when compared with tamoxifen(1).

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/novartis/36379/

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 suggested survival benefit from the ITT analysis is important considering that approximately 25% of patients in the tamoxifen arm selectively crossed over to Femara therapy after the tamoxifen arm was unblinded in 2005. While not statistically significant, these are the first data to suggest a survival benefit for an aromatase inhibitor versus tamoxifen in the monotherapy setting immediately following surgery.

To explore the impact of the selective crossover, an additional analysis was conducted censoring follow-up times at the date of crossover to letrozole. In this analysis, a 19% reduction in risk of death (HR=0.81, 95% CI: 0.69-0.94) was observed in favor of Femara.

The International Breast Cancer Study Group (IBCSG) pre
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SOURCE Novartis Pharmaceuticals Corporation
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