Special News About HRT

Estrogen-Progestin Combination Used in Women’s Health Initiative Study Found to Elevate Risks for Invasive Breast Cancer, Heart Disease, Stroke

The Susan G. Komen Breast Cancer Foundation Recommends Women on HRT Discuss Risks, Benefits with Their Physicians

The Susan G. Komen Breast Cancer Foundation recommends that women currently taking combination estrogen-progestin hormone replacement therapy (HRT) discuss the benefits and risks of such therapy with their medical providers. The recommendation is based on recent findings of a Women’s Health Initiative (WHI) randomized trial. WHI was testing whether combination HRT helps prevent coronary heart disease and hip fractures, and whether its use is associated with any changes in risk for breast cancer and colon cancer. The trial was stopped in May 2002 when the WHI’s Data Safety Monitoring Board noted increases in cardiovascular events, invasive breast cancer, and blood clot formation among trial participants.

A 26 percent increase in relative risk for breast cancer was reported three years into the trial. This means that instead of the anticipated 30 women in 10,000 that statistics show would likely have developed breast cancer, 38 women did. As the trial progressed, the breast cancer and cardiovascular outcomes began to exceed the pre-established threshold for patient safety. The risk of harm to an individual woman was described, however, as ‘very small’ in an article appearing in the Journal of the American Medical Association (JAMA).

The estrogen-progestin trial involving 16,000 women is one of many studies that are part of the WHI. A study involving over 11,000 women focusing on the risks and benefits of taking estrogen alone began at the same time the combination HRT study started. Trial participants in the ‘unopposed’ estrogen trial have had hysterectomies.

Hormone replacement therapy using a combination of estrogen and progestin has been prescribed for years to women who have a uterus to control such menopausal symptoms as hot flashes and night sweats. Many remain on HRT long after their symptoms have stopped or diminished in hopes of preventing cardiovascular disease and osteoporosis.

“The value of clinical trials is clear once again,” said Rebecca Garcia, PhD, vice president of Health Sciences for the Komen Foundation. “Without trials such as this, we would not be able to answer these key questions associated with hormone replacement therapy,” she said.

Dr. Garcia added, “The WHI findings underscore the need for all women to discuss HRT’s risks and benefits with their healthcare providers. Also, this highlights how important it is for women over the age of 40 to renew their commitment to monthly breast self- examination (BSE), yearly clinical breast examination and annual screening mammography."

For more information on breast cancer early detection, including a new breast self-examination instructional tool, visit www.komen.org.