Studies show HRT risks, lack of benefit

September 1, 2002

Pharmaceutical Representative

Researchers from the National Cancer Institute have found that women in a large study who used estrogen replacement therapy after menopause were at increased risk for ovarian cancer.

Researchers from the National Cancer Institute have found that women in a large study who used estrogen replacement therapy after menopause were at increased risk for ovarian cancer. The report was published in the Journal of the American Medical Association (vol. 288, no. 3).

The study, which followed 44,241 women for approximately 20 years, found that compared with postmenopausal women not using hormone replacement therapy, users of estrogen-only therapy had a 60% greater risk of developing ovarian cancer.

"The main finding of our study was that postmenopausal women who used estrogen replacement therapy for 10 or more years were at significantly higher risk of developing ovarian cancer than women who never used hormone replacement therapy," said James V. Lacey Jr., lead author of the study.

Estrogen combination therapy

In addition to studying the effect of estrogen use alone, Lacey and his colleagues examined whether women using estrogen-progestin therapy were more likely to develop ovarian cancer. No increased risk was found.

"Even though our data showed that women who took estrogen combined with progestin were not at increased risk for ovarian cancer, only a few women in our study who developed ovarian cancer had used estrogen-progestin therapy for more than four years," Lacey said. "So, at this point, there simply aren't enough data to say whether taking the combined therapy has any effect on ovarian cancer."

Past studies suggested that postmenopausal hormone treatments might be effective in preventing or reducing some of the negative long-term effects of aging, such as heart disease and osteoporosis. However, the results of a large, multi-center clinical trial published in the same issue of JAMA showed increases in breast cancer, coronary heart disease, stroke, and blood clots in the lungs and legs for women who had been on estrogen-progestin therapy for an average of 5.2 years. The trial, part of the Women's Health Initiative, also found fewer cases of hip fractures and colon cancer among women taking the combined therapy. However, because the overall harm was greater than the benefit, the trial was stopped three years ahead of schedule. The WHI randomized trial for use of estrogen alone in women who have had their uterus removed is continuing.

Informing doctors

Madison, NJ-based Wyeth Pharmaceuticals, maker of the top-selling estrogen replacement drug Prempro™ (conjugated estrogens/medroxyprogesterone acetate), said it is informing healthcare providers of the results of the study, but added that HRT is still a viable option for treating the symptoms of menopause.

"These are valuable new data with significant implications," said Victoria Kusiak, vice president of clinical affairs and North American medical director for the company. "However, it is also important to recognize the critical role that combination HRT plays in treating the symptoms of menopause, the number one reason that women start therapy." Kusiak cited a survey revealing that doctors reported management of symptoms as a treatment goal for nine out of 10 new patient prescriptions for combination HRT.

While the results of the study highlight the need for individual risk/benefit assessment for all patients, the NCI's Lacey emphasized the complexity of weighing the various risks and benefits of hormone use. Said Lacey, "Because hormone therapy may influence so many conditions that affect women after menopause - cardiovascular disease, osteoporosis, breast cancer, uterine cancer, gallbladder disease, blood clots and now potentially ovarian cancer - we should no longer think of a woman basing her decision to use hormones on the potential risk of just one condition. Women should continue to talk to their healthcare providers about whether hormones might be right for them." PR

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