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Better survival seen for early breast cancer patients switched from tamoxifen to Aromasin

on cancers occurring in women with more than one million women diagnosed each year worldwide. "The Aromasin overall survival data announced today means that women are moving closer to the goal of longer survival." said Lead US Investigator, Stephen Jones, M.D., medical director, and co-chair, breast cancer research committee of the US Oncology Research Network and director of breast cancer research at the Texas Oncology Baylor-Sammons Cancer Center in Dallas.

With the new 5 year follow-up data, no clinically meaningful changes in the safety profile were noted. According to Professor Coombes, "We have also now been able to study the long-term effects of exemestane after completion of therapy, and our results provide women and their physicians with important long-term information on the use of exemestane."

At 34.5 months of follow-up, the most common side effects were mild-to-moderate and include hot flushes (21.2% for Aromasin vs. 19.9% for tamoxifen), fatigue (16.1% vs. 14.7%), arthralgia (14.6% vs. 8.6%), headache (13.1% vs. 10.8%), insomnia (12.4% vs. 8.9%), and increased sweating (11.8% vs. 10.4%). AROMASIN should not be used in women who are premenopausal, are nursing or pregnant, have a known hypersensitivity to the drug, or are taking estrogen-containing agents. Dose modification is recommended for patients who are receiving certain medications, including strong CYP 3A4 inducers. In patients with early breast cancer, elevations in bilirubin, alkaline phosphatase, and creatinine were more common in those receiving AROMASIN than either tamoxifen or placebo.

Aromasin was approved in the United States in 2005 for treatment of postmenopausal women with estrogen-receptor positive early breast cancer following two-to-three years of tamoxifen, for a combined total of five consecutive years of therapy. It also is approved for use in Canada, Europe, Japan and South America. Currently, Aromasin is available in more than 80 countries and approved
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3-Jun-2006


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