New Drug Dramatically Reduces Breast Cancer Risk

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NEW DRUG DRAMATICALLY REDUCES BREAST CANCER RISK

Known risk factors for breast cancer include: (1) age greater than 60, (2) a previous personal history of breast cancer or precancerous conditions of the breast (such as atypical lobular hyperplasia, lobular carcinoma in situ, atypical ductal hyperplasia, or ductal carcinoma in situ), (3) one or more first degree relatives with breast cancer, (4) A personal history or family history of BRCA-1 or BRCA-2 hereditary breast and ovarian cancer gene mutations, (5) not having children, or having children after age 35, (6) multiple prior breast biopsies for non-cancer lumps, and (7) early-onset of menstruation, or late onset of menopause, as well as other less powerful breast cancer risk factors.

There are very few prescription medications available that significantly reduce the risk of developing cancer. However, for women who are at increased risk of developing breast cancer, the so-called SERMs (Selective Estrogen Receptor Modulators) can significantly reduce breast cancer risk. The most widely prescribed SERM is tamoxifen, which has been shown to decrease the risk of developing breast cancer, in high-risk women, by nearly 50 percent. However, while tamoxifen is commonly prescribed for women who have hormone-sensitive breast cancer (because this drug also reduces the risk of breast cancer recurrence in such cases), it is not widely prescribed for cancer prevention purposes.

There are several reasons why tamoxifen is not frequently prescribed as a breast cancer prevention medication. First of all, tamoxifen is most commonly prescribed by Oncologists, and so most primary care physicians are not comfortable enough with this medication to prescribe it. Secondly, tamoxifen has been associated with potentially serious side effects, including an increased risk of uterine cancer, blood clots in the veins and lungs, and cataracts. (Another SERM, raloxifene, does not appear to significantly increase the risk of uterine cancer, but this medication otherwise has the same potential side effects as tamoxifen.)

A new class of estrogen-blocking medications, aromatase inhibitors, is now commonly used in place of tamoxifen as hormone-blocking therapy in postmenopausal patients with breast cancer. Although aromatase inhibitors, like virtually all medications, have side effects of their own, they are not known to be associated with an increased risk of cancer or potentially life-threatening blood clots, like tamoxifen, and they appear to be even more effective in reducing the risk of breast cancer recurrence than tamoxifen and other SERMs.

Now, a newly published clinical research study, which appears in the current issue of the New England Journal of Medicine, has revealed that exemestane, an aromatase inhibitor, appears to be even more effective in preventing breast cancer than tamoxifen (as well as being safer, in terms of side effects, than tamoxifen).

This clinical research trial was a prospective, randomized, placebo-controlled, double-blinded study (which is the “gold standard” method of performing clinical research). A total of 4,560 women, ages 35 and older (the average age was 63 years), were enrolled in this clinical research study, and were secretly and randomly assigned to receive either exemestane or an identical-appearing placebo (“sugar pill”). These patient volunteers, all of whom were at increased risk of developing breast cancer, were then followed for an average of about 3 years.

By the end of the study, 11 women in the exemestane (treatment) group had developed breast cancer, while 32 women in the placebo (control) group were diagnosed with breast cancer. These findings translated into a 65 percent reduction in the risk of developing breast cancer associated with the use of exemestane in these high-risk women.

Although the prolonged use of aromatase inhibitors can lead to osteoporosis (“thinning” of the bones), there was no increase in the incidence of bone fractures or other skeletal complications noted among the women who took exemestane during the course of this research study. (Aromatase inhibitors can also cause significant bone and joint pain.) Indeed, during the course of this clinical study, there were no significant differences between the exemestane group and the placebo group in terms of side effects or complications.

Therefore, this breakthrough clinical research study showed that an aromatase inhibitor, exemestane, was more effective in preventing breast cancer in high risk women than tamoxifen and other SERMs; and unlike tamoxifen, exemestane did not appear to be associated with any significant side effects or complications following three years of treatment. Because of this clinically important combination of greater effectiveness and fewer side effects, this study’s findings are highly likely to change recommendations for the “chemoprevention” of breast cancer in women who are at an elevated risk of developing this most common of cancers in women. (One important caveat to note is that aromatase inhibitors, unlike tamoxifen and other SERMS, can only be used in postmenopausal women.)



 

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Disclaimer:  As always, my advice to readers is to seek the advice of your physician before making any significant changes in medications, diet, or level of physical activity



Dr. Wascher is an oncologic surgeon, professor of surgery, cancer researcher, oncology consultant, and a widely published author



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