Aromasin® Approved for Early Breast Cancer

Cancer Connect

The United States Food and Drug Administration recently approved the aromatase agent Aromasin® (exemestane) for treatment in early, hormone-positive breast cancer in postmenopausal women following two to three years of treatment with Nolvadex® (tamoxifen).

Aromasin was previously approved for the treatment of advanced, hormone-positive breast cancer in postmenopausal women whose cancer had progressed following treatment with tamoxifen.

Breast cancer is diagnosed in over 200,000 women annually in the US alone. If breast cancer is caught and treated in early stages (prior to spread), cure rates are high with standard treatments. A large portion of patients have hormone-positive breast cancer-cancer that is stimulated to grow by the circulating female hormones estrogen and/or progesterone. Hormone therapy, often used to treat hormone-positive breast cancer, utilizes agents that reduce or prevent the ability of estrogen to stimulate the growth of cancer cells.

Tamoxifen (Nolvadex®), which binds to estrogen receptors in a cell, inhibiting production of estrogens growth-stimulatory effects, was historically the most commonly used agent for hormone-positive breast cancer. However, agents referred to as aromatase inhibitors, which are now being used more frequently. Aromatase agents actually prevent or reduce the production of estrogen in the body.

Aromasin is an aromatase agent that was previously approved for the treatment of advanced hormone-positive breast cancer in postmenopausal women who had cancer that had progressed following treatment with tamoxifen. The newly-approved indication allows for its use in postmenopausal women with early breast cancer, or cancer that has not spread to distant sites in the body, following two to three years of treatment with tamoxifen.

The trial that prompted the new indication for Aromasin was referred to as the Intergroup Exemestane Study (IES), which included 4,700 postmenopausal women with hormone-positive early breast cancer. Patients first underwent surgery and were treated with either tamoxifen for 5 years, or tamoxifen for 2 to 3 years, followed by Aromasin.

  • Patients who were switched to Aromasin had a 31% reduced risk of developing a cancer recurrence compared to those who remained on tamoxifen.
  • Treatment with Aromasin is well tolerated with hot flashes and fatigue being the most common side effects.

Postmenopausal women with hormone-receptor positive early breast cancer who have been taking tamoxifen may wish to speak with their physician regarding their individual risks and benefits of switching to Aromasin or other aromatase inhibitors.

Reference: Pfizer. FDA Approves Pfizers Aromasin® for Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women. Available at: . Accessed October 2005.

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