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Novartis’ Femara improves long-term breast cancer survival

Women with hormone-sensitive early breast cancer who switched to Novartis' Femara from placebo as part of a landmark trial experienced significant improvements in overall survival, disease-free survival and risk of distant metastases.

The trial was designed to determine whether longer-term treatment with an aromatase inhibitor (Femara) post tamoxifen therapy, would offer any clinical benefit to postmenopausal women with early breast cancer. As such, the women taking part in the study had already completed a standard five year course of tamoxifen, and were then given either Femara or placebo.

In 2003, compelling results of an interim analysis showed that Femara reduced the risk of breast cancer coming back by 42% compared with placebo. These data prompted an independent data safety monitoring board to recommend the unblinding of study results. Since then, approximately 1,655 women taking placebo have chosen to switch to Femara, while another 613 women did not pursue further treatment.

In this new analysis, postmenopausal women who switched from placebo to Femara experienced a 69% reduction in the risk that their breast cancer would return. There also was a 72% reduction in the risk that the cancer would spread to a distant part of the body. A 47% reduction in the risk of dying from their disease was also observed. The data was presented at the 5th European Breast Cancer Conference (EBCC), Nice.

“The results presented today provide the first clinical evidence that women can benefit from Femara even years after the completion of standard treatment. The findings may have a substantial impact on the overall treatment outcomes for postmenopausal women.” said Dr Andrew Wardley, study investigator and consultant medical oncologist at The Christie Hospital, Manchester, and The South Manchester University Hospital NHS Trust.