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Breast Cancer Drug is Safer: Bone-Strengthening Medication Has Fewer Side Effects, Study Says

Posted on: Tuesday, 18 April 2006, 12:00 CDT

By Misti Crane, The Columbus Dispatch, Ohio

Apr. 18--Declaring their discovery good news for the millions of American women at high risk of breast cancer, researchers said they've found a safer alternative to the only medicine approved to prevent the disease.

Tamoxifen has been shown to cut cancer risk in half. But because of side effects -- particularly the potential for uterine cancer -- some women and their doctors have shied away.

"It got little use because of the rare but serious side effects," said Dr. Leslie Ford, associate director for clinical research in the National Cancer Institute's cancer-prevention division.

Another pill currently used to strengthen bones, raloxifene, appears to fight cancer just as well with a lower risk of uterine cancer and life-threatening blood clots.

The news comes from one of the largest prevention studies, a head-to-head comparison of the drugs in 19,747 women, including 949 in Ohio.

The study included only women who had gone through menopause, meaning its results can only be applied to that group. The National Cancer Institute paid $88 million for the study and Eli Lilly, makers of raloxifene, paid $30 million.

To qualify for the study, women had to have a breast-cancer risk equal or greater than an average 60-year-old woman. Most of the women in the study doubled that, with a 3 percent to 4 percent risk of developing invasive breast cancer in the next five years. They took the medicine for an average of four years.

There were 163 cases of invasive breast cancer in the tamoxifen group and 167 in the raloxifene group, statistically a tie.

But the raloxifene group had 36 percent fewer uterine cancers and 29 percent fewer blood clots in major veins and the lungs.

For every 1,000 women with a risk similar to those in the study, 40 would be expected to develop breast cancer in five years without medication.

Mary Ann Badurina, whose three sisters had breast cancer, was among those to sign up for the study.

The 71-year-old Grove City woman did it with her two daughters and two granddaughters in mind.

"I thought, 'Gee, if I could help,' " Badurina said. "I'm just hoping they'll never have to have anything like that."

As of yesterday, Badurina did not know which drug she'd taken for five years. The only side effects of any note were hot flashes, she said. Menopauselike symptoms are possible with both medications.

"It wouldn't have been enough to make me quit taking the pills."

Of the 9 million women whose risk is high because of factors including a mother, sister or daughter with the disease, about 2 million would benefit from tamoxifen, according to previous research. Results from this study point to higher numbers of women who could prevent breast cancer without suffering serious side effects, researchers said yesterday.

Breast-cancer risk is calculated using age, family history and other factors, including a woman's age at her first period. To calculate your risk, go to http://www.cancer.gov/bcrisktool.

It is up to each woman and her doctor to consider the risks and benefits, said Dr. Philip Kuebler, who worked on the research and is principal investigator for the Columbus Community Clinical Oncology Program.

"Now more women will win in that equation between benefit in terms of prevention and the side effects," he said. "We live in a very wonderful time in some aspects. . . . Never before in the history of man have we been able to prevent cancer with a medicine."

The next major study on prevention will be a comparison of raloxifene with aromatase inhibitors, another class of drugs that has shown great promise in prevention, he said.

Eli Lilly is expected to ask the Food and Drug Administration for swift approval of their drug for breast-cancer prevention. Without FDA approval, doctors may prescribe it at their discretion, a practice known as off-label use.

On average, a month's worth of generic tamoxifen costs about $100 compared with $75 for raloxifene, which is not yet available in generic form.

mcrane@dispatch.com

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Source: The Columbus Dispatch, Ohio

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