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Newly Published Study Reveals Femara Improves Chances for Harder to,Treat Early Breast Cancer Relapse in Postmenopausal Women

h tamoxifen Femara also demonstrated a significant reduction in the risk of recurrence to the same breast (local recurrence), the other breast and to the lymph nodes (regional recurrence).

"Femara is the only aromatase inhibitor shown to significantly reduce the risk of distant metastases versus tamoxifen as initial adjuvant therapy in postmenopausal women with hormone-sensitive early breast cancer. This is particularly good news since we know that this type of recurrence significantly worsens the prognosis for these women," said Dr Andrew Wardley, study investigator and consultant medical oncologist at the Christie Hospital, Manchester, and the South Manchester University Hospitals NHS Trust.

The retrospective analysis also identified patients at higher risk of recurrence based on clinical and pathological disease characteristics. The results showed that patients with the highest risk of early recurrence had tumours larger than five centimetres, four or more positive nodes, positive oestrogen receptor status but negative progesterone status, grade three tumours and invasive disease. Notably, women with node positive disease, who are considered to be at a higher risk of recurrence, maintained this lower risk of relapse when treated with upfront Femara than with tamoxifen(1).

"These results provide the tip of the iceberg and for the bigger picture, physicians will be eagerly awaiting the results of the BIG 1-98 sequencing arms, which hope to indicate the optimal strategy for using Femara post surgery and are due to be ready for 2008. This is why Novartis has made a significant commitment to sponsor this important study", said Hugh O'Dowd, Business Unit Director, Novartis Oncology UK.

Notes to Editors

About BIG 1-98

BIG 1-98 is the only clinical trial that incorporates both a head-to-head comparison and a sequencing of Femara and tamoxifen as adjuvant treatment for postmenopausal women with hormone receptor positive breast can
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