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Back To Vidyya FDA Approves Arimidex (Anastrozole) As First-Line Therapy For Advanced Post Menopausal Breast Cancer

Arimidex Stops The Production Of Estrogen From The Adrenal Glands

The US Food and Drug Administration (FDA) has approved AstraZeneca's breast cancer treatment Arimidex® (anastrozole) as a new treatment option for postmenopausal women first diagnosed with advanced or locally advanced breast cancer whose cancers are hormone receptive.

Arimidex is the first aromatase inhibitor to be approved for first-line treatment in the U.S. Previously, Arimidex was only approved for use after disease progression following tamoxifen treatment. Two pivotal studies found that Arimidex was as effective and well tolerated as tamoxifen when prescribed at the time of diagnosis for women with advanced breast cancer.

"It's important for patients to have the option to receive Arimidex therapy when they are first diagnosed with advanced breast cancer," said Gershon Locker, M.D., medical oncologist at Evanston-Northwestern Healthcare. "Arimidex has been shown to be as effective as tamoxifen is in women with advanced disease and study data suggest Arimidex may lessen the rate of disease progression."

The North American trial 030 showed Arimidex had a statistically significant advantage over tamoxifen for time to tumor progression with an average of 11.1 months for Arimidex versus 5.6 months for tamoxifen. The complete and partial tumor response rates were not different between the two groups. The European trial 027 showed Arimidex was as effective as tamoxifen with respect to both time to progression and tumor response rate. Patients with estrogen receptor positive breast cancer received the greatest benefit from Arimidex.

At least 10,500 women are diagnosed with advanced breast cancer each year. With the variety of treatment options available today, more women with advanced breast cancer are living longer with the disease. Advanced breast cancer is diagnosed when cancer that is originally confined to the breast is found in other parts of the body. More specifically, a woman is considered to have advanced disease when breast cancer cells form a tumor in places such as the lungs, liver or bones.

Arimidex was first approved in 1996 as a treatment for postmenopausal women with advanced breast cancer who progressed following hormonal treatment with tamoxifen. Arimidex is a non-steroid aromatase inhibitor, which works to lower the amount of circulating estrogens in the body. Arimidex and tamoxifen work in very different ways. Arimidex stops the production of estrogen from the adrenal glands (near the kidneys) a main source of estrogen for post-menopausal women. Tamoxifen interferes with the cancer cell's ability to use estrogen for fuel to divide and grow. Arimidex is also currently being evaluated in comparison to tamoxifen as an adjuvant therapy for early breast cancer in a multinational trial called ATAC (Arimidex, Tamoxifen And Combination therapy) with results expected in 2001.

Arimidex is indicated for the treatment of advanced breast cancer in post-menopausal women with hormone receptor positive or hormone receptor unknown disease. Patients must exclude pregnancy before taking Arimidex as it may cause fetal harm when administered to a pregnant woman. Side effects including, nausea, headache and hot flashes have been reported during treatment with Arimidex. Arimidex is administered orally, once daily as 1-mg tablets.

For full prescribing information on Arimidex, call Mary Lynn Carver at 302-886-7859.


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Editor: Susan K. Boyer, RN
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