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2.4 Million US Women Could Benefit from Taking Tamoxifen

November 28, 2003

) - As many as 2.4 million American women could benefit by taking the drug Tamoxifen to reduce their risk of developing breast cancer. That's the conclusion of research by the National Cancer Institute published in the April 2nd issue of the Journal of the National Cancer Institute.In 1998, the Food and Drug Administration approved the use of Tamoxifen as a chemo preventative against breast cancer in high-risk women. NCI researcher Andrew Freedman, PhD, and colleagues, weighed the risk of developing breast cancer against the benefits and risks of taking Tamoxifen. While research has shown that Tamoxifen reduces the incidence of breast cancer by 49%, taking the drug carries risks too, which, though rare, include stroke, pulmonary embolism, endometrial cancer and deep vein thrombosis. To determine a woman's risk of developing breast cancer, the researchers used the a risk assessment tool, the Gail model, which assigns a risk rating based on a woman's health history. It factors in a woman's age at first menstruation, date of first live birth, existence of close family members with breast cancer and the outcomes of any previous breast biopsies.According to the FDA, a Gail rating over 1.67 is considered high risk for developing breast cancer over the next five years. This rating is applicable to the general female population not women who have other identifiable risk factors such as mutation in one of the BRCA genes. Freedman took data from the 2000 National Health Interview Survey and calculated the number of women in the U.S. in the year 2000 who would likely qualify as high risk according to the FDA criteria. That number came to 15.5 percent of American women aged 35 to 79 or about 10 million women. But because taking Tamoxifen carries risks too, Freedman created a benefit/risk index for these 10 million women to identify what percentage would end up on the plus side of the equation from taking the drug. (Freedman discusses the Gail model and the benefit/risk index. Click here to listen.) "At least among white women, 2.4 million would likely benefit from taking Tamoxifen. Most of those women are in the age category of 40-49 and 50-59," Freedman told of the benefit was to women in the age group of 40-49. Among older women, a similar risk/benefit index was achieved but for a smaller group."Women in the ages of 50 to 59, were about 8% as well who benefited although all those women happen to have had a hysterectomy or had their uterus removed so they didn't have the possibility of developing endometrial cancer, which is a side effect of Tamoxifen," Freedman explained. (To hear his complete remarks, click here.) The net benefit of taking Tamoxifen for black women is less clear because, Freedman says, black women overall have a lower risk of developing breast cancer but appears, according to mortality data, to suffer a higher incidence of stroke and pulmonary embolism. (Click here to listen to Freedman's full remarks.) So what should women do? The NCI is a long way from recommending for or against taking Tamoxifen prophylactically. A woman will have to weigh many factors " ...including their age, their breast cancer risk factors, whether or not she has a uterus, cardiovascular risk factors, her family history and how she personally weighs the benefits and risks as well as her specific life style, personal values and preferences," Freedman advises. (Click here to listen to hear full remarks.) What's not known yet is what effect long-term use of Tamoxifen might have. The NCI continues to follow women who participated in clinical trials of Tamoxifen but, according to Freedman, the data only cover four or five years of Tamoxifen use. "For longer term use, those questions are still not answered," he says. There are also newer drugs in the pipeline that may have similar breast cancer preventative effects without the side effects of Tamoxifen.If you would like to see what your Gail rating is, visit the NCI's Breast Risk Assessment tool at interview with Andrew Freedman, PhD, April 1, 2003Journal of the National Cancer Institute 2003; 95: 526-532

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