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Results In 'The New England Journal Of Medicine' Confirm Novartis Drug Femara(R) Is Superior To Tamoxifen After Breast Cancer Surgery
Date:8/19/2009

with a corresponding reduction in risk of disease-free survival events (12%, P=0.03) compared with patients treated with tamoxifen alone for the same duration.

The analysis also revealed a non-significant trend towards an overall survival benefit with five years of Femara therapy following surgery (13% reduced risk of death, P=0.08) versus tamoxifen for five years following surgery. This occurred even though approximately 25% of patients in the tamoxifen arm selectively crossed over to Femara therapy after the tamoxifen arm was unblinded in 2005 due to the superiority of Femara over tamoxifen[1]. This crossover confounds the evaluation of the true differences between letrozole and tamoxifen. The study group therefore, conducted a retrospective censored analysis that was not protocol-defined and in which observation times were censored at the date of crossover. Time and events beyond the crossover were ignored in patients who selectively crossed over to Femara. In this censored analysis, there was an improved survival benefit for patients receiving five years of Femara versus tamoxifen (19%; HR 0.81; 95% CI: 0.68, 0.96). According to the authors, these censored results may be an overestimate of the Femara benefit since women who had recurrent disease were not candidates for the crossover. It is likely that the most accurate assessment of the survival benefit with Femara is between these two analyses - 13-19% reduction in the relative risk of death compared with tamoxifen[2].

BIG 1-98 is the only clinical trial designed to explore both a head-to-head comparison of an aromatase inhibitor versus tamoxifen monotherapy, as well as sequencing of an aromatase inhibitor and tamoxifen therapy in the first five years following breast cancer surgery, in order to determine the most effective way to minimize breast cancer recurrence. In the initial adjuvant setting, Femara is the only aromatase inhibitor to have consistently demonstrated a
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SOURCE Novartis Pharmaceuticals Corporation
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