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Title: ASCO MEETING: Aromasin Improves Survival In Post-Menopausal Breast Cancer Patients
URL: http://www.pslgroup.com/dg/FE316.htm
Doctor's Guide
May 17, 1999


ATLANTA, GA -- May 17, 1999 -- New data suggest that Pharmacia & Upjohn's Aromasin(R) (exemestane tablets), an oral aromatase inactivator, provides significant survival benefit for post-menopausal women with metastatic breast cancer that has progressed despite treatment with tamoxifen.

In a large study presented this weekend at the 35th annual meeting of the American Society for Clinical Oncology (ASCO), the efficacy of Aromasin was compared to that of a standard hormonal therapy (megestrol acetate) in patients who experienced tamoxifen failure. Researchers found that Aromasin reduced the risk of tumour progression by 18 percent and the risk of death by 23 percent.

"For postmenopausal women with breast cancer for whom hormonal therapy is appropriate, Aromasin has shown benefits," said Dr. Stephen Jones, director, Breast Cancer Research, Baylor University Medical Center and Physicians Reliance Network and one of the lead U.S. researchers on the study. "This study suggests that Aromasin offers a survival advantage over a standard hormonal therapy."

Aromasin is an aromatase inactivator that works by selectively targeting and irreversibly binding to the aromatase enzyme, a key enzyme required to produce estrogen, which some breast cancer cells need to survive. Once the binding occurs, estrogen can never be made by that enzyme again. With the inactivation of the aromatase enzyme, exemestane cuts off the supply of estrogen to cancerous cells and prevents the cells from continuing to grow. The method of action of the aromatase inactivator differs from older aromatase inhibitors because it binds irreversibly to the aromatase enzyme, permanently blocking its function.

Enrolling 769 post-menopausal women whose cancer had metastasised, the phase III, double blind, randomised study suggests that Aromasin (one 25 mg pill daily) provides greater benefit than megestrol acetate (40 mg four times daily) in survival, tumour reduction and the duration of disease stabilisation. Patients taking megestrol acetate had a median survival (estimated time at which 50 percent of the patients were still alive) of approximately 28 months, while patients taking Aromasin had a median survival significantly longer than 28 months. Researchers also found a significant difference in favour of Aromasin in delaying the progression of cancer (4.7 versus 3.8 months). Additionally, 15 percent of patients treated with Aromasin experienced at least a 50 percent or greater reduction in the size of the tumour or a complete disappearance of all known lesions (objective response rate equals complete tumour responses plus partial tumour responses), compared to 12.4 percent for megestrol acetate, though this was not statistically significant.

Given its potent suppression of estrogen, Aromasin use was associated with expected low-grade nausea (18.4 percent) and hot flashes (13.4 percent). Aromasin was also associated with less undesirable weight gain (7.6 percent versus 17.1 percent) than megestrol acetate. Aromasin should not be administered to women with premenopausal endocrine status.

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