04/18/06 — Wayne County clinic part of breast cancer drug trial

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Wayne County clinic part of breast cancer drug trial

By Phyllis Moore
Published in News on April 18, 2006 1:50 PM

Initial results are in from one of the largest breast cancer prevention studies ever done, with local health officials hopeful that women will take advantage of having a second drug option.

Southeastern Medical Oncology was one of more than 500 centers across the U.S., Canada and Puerto Rico that participated in the clinical trial of the Study of Tamoxifen and Raloxifene, or STAR, which began in 1999.

The osteoporosis drug raloxifene has been shown to be as effective as tamoxifen in preventing invasive breast cancer. Both drugs are known to protect bone health.

Dr. James Atkins of Southeastern Medical Oncology Center said the findings bring welcome news to women.

“The good thing is that raloxifene was shown to be just as effective as tamoxifen, so now we have two drugs for breast cancer,” he said. “Raloxifene had the lower side effects. The two drugs were excellent in preventing cancer for high risk women.”

An estimated half a million postmenopausal women are said to currently be taking raloxifene by prescription either to prevent or to treat osteoporosis. Initial results from STAR suggest that raloxifene does not increase the risk of developing cataracts, as tamoxifen does.

“Although no drugs are without side effects, tamoxifen and raloxifene are vital options for women who are at increased risk of breast cancer and want to take action,” said Leslie Ford, M.D., associate director for clinical research in the National Cancer Institute’s Division of Cancer Prevention. “For many women, raloxifene’s benefits will outweigh its risks in a way that tamoxifen’s benefits do not.”

STAR enrolled 19,747 postmenopausal women who were considered at increased risk of the disease. At Southeastern, 65 women were enrolled and 50 were actively followed. A total of 915 were enrolled across the state.

Participants were randomly assigned to receive either 60 mg of raloxifene or 20 mg of tamoxifen daily for five years. Women taking either drug had equal numbers of strokes, heart attacks and bone fractures.

The STAR researchers also tracked known menopausal side effects that occur with both drugs and monitored the participants’ quality of life. Data showed that side effects of both drugs were mild to moderate in severity and quality of life was the same for both drugs.

Participants in the drug trial are now receiving information about which drug they were taking. Women assigned to raloxifene will continue to receive the drug until they have completed five years of treatment. Those assigned to tamoxifen can choose to continue on that medication or to receive raloxifene to complete their five years of treatment.

Dr. Atkins said in the local trials, one-fourth of the patients had a five-year risk of getting breast cancer. Of greater concern, though, is that “most women have no idea what their risk of getting breast cancer is, and that’s a problem,” he said.

There are ways to calibrate the risk, he said. Six or seven questions, a two-minute online test, and women can find out their risk of getting breast cancer, he said. The Web site is www.breastcancerprevention.com.

“It’s just like mammograms. Mammograms don’t help women if they don’t get them done. Having preventive measures doesn’t help if women don’t know they’re at risk,” he said.

About 48,000 women die from breast cancer every year in this country, Atkins said, a number he deems unacceptable.

“We have got to find ways to prevent it. This is just another step in that direction,” he said.

With the second drug option, Atkins said, “This is an exciting time. We have come a long way in trying to prevent breast cancer. We would much rather prevent it than have to treat it.”

Sharon Jones participated in the local study in part to lend support to her sister, who had breast cancer.

“It makes me feel as though I am doing what I can to help myself and others who are at risk of getting breast cancer,” she said.

Atkins said another breast cancer prevention trial is expected to start in a few months, but he hasn’t been told which drugs will be used.