SAN ANTONIO, Dec. 9 /PRNewswire-FirstCall/ -- Studies presented today at the San Antonio Breast Cancer Symposium analyze the AstraZeneca drug ARIMIDEX(R) (anastrozole) in terms of overall survival, recurrence-free survival and safety. ARIMIDEX, an aromatase inhibitor, is the only drug in its class that is approved by the U.S. Food and Drug Administration (FDA) for initial adjuvant treatment of hormone receptor-positive early breast cancer in postmenopausal women.
The full FDA approval status for ARIMIDEX is supported by one of the world's longest running and largest studies of breast cancer treatment after surgery, the Arimidex, Tamoxifen Alone or in Combination (ATAC) Trial. ATAC data demonstrated that women who took ARIMIDEX had a lower risk of disease recurrence compared to those who took tamoxifen.
Data presented today at 9:30 A.M. reviewed a five-year analysis of ABCSG Trial 8, a study in which postmenopausal, hormone receptor-positive breast cancer patients who had been treated with tamoxifen for two years, were either switched to ARIMIDEX or remained on tamoxifen for a total of five years of treatment (see general session 3, program 13, R. Jakesz, MD).
In a separate presentation, data from a meta-analysis combining the ABCSG Trial 8 data with two additional studies in which patients were switched from tamoxifen to ARIMIDEX (see general session 3, program 19, W. Jonat, MD) were reported.
"Clearly, more data are needed to draw conclusive long-term overall survival results. These studies should help further define the clinical benefits of aromatase inhibitors," explains Aman Buzdar, MD, the University of Texas M. D. Anderson Cancer Center, Houston, and chair-elect of the ATAC Trial. "Optimal therapy for postmenopausal women with hormone receptor- positive early breast cancer should include an aromatase inhibitor."
Also presented today (Poster # 2052) were initial findings from the Letrozole, Exemestane, and Anastrozole Pharmacodynamics (LEAP) trial, which provides direct comparisons of lipid profile parameters among aromatase inhibitors (AIs) in healthy postmenopausal women.
About ARIMIDEX(R) (anastrozole)
ARIMIDEX is indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.
Important Safety Information About ARIMIDEX
ARIMIDEX should only be used in postmenopausal women. ARIMIDEX can cause fetal harm when administered to a pregnant woman. Before starting treatment, pregnancy must be excluded (see WARNINGS in full Prescribing Information). Common side effects seen with ARIMIDEX in the early breast cancer clinical trial include hot flashes, joint symptoms, weakness, mood changes, pain, sore throat, nausea and vomiting, depression, high blood pressure, osteoporosis, swelling of arms-legs, and headaches. Fractures, including spine, hip, and wrist fractures, occurred more often with ARIMIDEX than tamoxifen.
ARIMIDEX should not be taken with tamoxifen or estrogen-containing therapies.
Important Information About Tamoxifen
NOLVADEX(R) (tamoxifen citrate) is approved for the adjuvant treatment of node-positive and node-negative early breast cancer in postmenopausal women following breast surgery and radiation. In some NOLVADEX adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.
Important Safety Information About Tamoxifen
WARNING: Serious and life-threatening events associated with NOLVADEX include cancer of the uterus, stroke, and blood clots, some of which have been fatal. In clinical trials, uterine cancers, including endometrial cancer and uterine sarcomas, and blood clots, including clots in the lungs, occurred 2 to 4 times more often with NOLVADEX than placebo, but each occurred in less than 1% of women. For most women with breast cancer, the benefits of NOLVADEX outweigh its risks. If you are taking NOLVADEX to reduce your risk of developing breast cancer because you are at high risk or have DCIS, you should discuss these warnings with your healthcare provider.
Women who are pregnant or who plan to become pregnant should not take NOLVADEX. Women who have a history of blood clots or who currently use anticoagulants (blood thinners) should not take NOLVADEX for DCIS or to reduce their risk of breast cancer. Cataracts and cataract surgery occurred more frequently with NOLVADEX. The most frequently reported adverse reactions were hot flashes and vaginal discharge.
Please see full Prescribing Information including boxed WARNING regarding NOLVADEX Tablets.
ARIMIDEX and NOLVADEX were developed and are distributed by AstraZeneca , a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
For further information about AstraZeneca and full Prescribing Information please visit http://www.astrazeneca-us.com or http://www.arimidex.com.
This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2004.
ARIMIDEX and NOLVADEX are registered trademarks of the AstraZeneca group of companies.
(C) 2005 AstraZeneca Pharmaceuticals LP. All rights reserved.
AstraZenecaCONTACT: Heather L. Warta, AstraZeneca, +1-302-885-9515,heather.warta@astrazeneca.com
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