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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

ersity Hospital and BIG 1-98 investigator. "Letrozole is the only aromatase inhibitor versus tamoxifen to demonstrate early and significant reduction in the risk of distant metastases, significant improvement in disease-free survival and this suggestion in overall survival benefit in primary breast cancer patients."

"A primary goal in treating adjuvant breast cancer is to reduce the number of early, life-threatening distant metastases. The data show the significant long-term benefit of Femara and these results will have an impact on clinical practice in the US," said Kimberly Blackwell, MD, associate professor of medicine at the Duke University Medical Center. "A treatment strategy of letrozole for five years immediately following surgery may help protect postmenopausal women with hormone-receptor positive breast cancer from recurrence of their disease."

Sequential Treatments Analysis (STA)

Results of the STA (median follow-up of 71 months) concluded that sequential treatment with tamoxifen did not improve disease-free survival compared with Femara alone. In the study, patients either received sequential treatment with Femara and tamoxifen (two years of Femara followed by three years of tamoxifen or two years of tamoxifen followed by three years of Femara) or five years of Femara alone. Five-year disease-free survival rates for the three groups of patients in the STA were 87.9% for those patients receiving Femara only, 86.2% for those patients receiving tamoxifen followed by Femara and 87.6% for those patients receiving Femara followed by tamoxifen.

Monotherapy Arms Analysis (MAA)

Updated results from the MAA (median follow-up of 76 months) confirm the significant long-term benefit of Femara. The data demonstrated that patients who took Femara alone for five years following surgery experienced a significant reduction in the risk of distant metastases (15%, P=0.05)
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SOURCE Novartis Pharmaceuticals Corporation
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