- The Washington Times - Monday, April 17, 2006


A newer drug prevents breast cancer in older, high-risk women just as well as today’s standby tamoxifen — but with fewer side effects, the National Cancer Institute announced yesterday.

Called raloxifene, the newer drug is currently sold to treat bone-thinning osteoporosis.

But the new results, from a government study of nearly 20,000 women, suggest that raloxifene may supplant its older cousin as the first choice for breast cancer prevention in postmenopausal women at high risk of developing the disease.

“Now women have a choice,” Dr. Leslie Ford of NCI stressed yesterday. “It’s good news, because we’re giving you a choice with fewer side effects.”

Manufacturer Eli Lilly and Co., which sells raloxifene under the brand name Evista, plans to seek Food and Drug Administration approval for the new use.

Until now, tamoxifen has been the only drug approved to reduce the chances of breast cancer among high-risk women. It’s a multiple-use drug: It acts like the estrogen hormone in some tissues, but like an anti-estrogen in others.

Estrogen can fuel certain breast cancers, making tamoxifen a longtime top choice both to reduce the odds of cancer striking high-risk women and to prevent the disease’s return in women with estrogen-sensitive tumors.

Tamoxifen, however, causes some rare but serious side effects: It acts like an estrogen in the uterus and bloodstream, thus increasing users’ risk of getting uterine cancer or a life-threatening blood clot.

Raloxifene is a close chemical relative, in the same drug family known as “selective estrogen response modulators,” and earlier research suggested that it might help breast cancer, too. So the NCI began the $88 million study to compare the two.

Taking either tamoxifen or raloxifene every day cut in half women’s chances of developing invasive breast cancer, NCI said yesterday.

Raloxifene causes the same side effects, but not as many: Raloxifene users had 36 percent fewer uterine cancers and 29 percent fewer blood clots, the initial results show.

About 2 million U.S. women every year are thought to be candidates for tamoxifen risk-reduction therapy, but many have avoided it for fear of those side effects, said Dr. Kathy Albain of Loyola University, a researcher in the new study.

“Here we have something that’s a little less scary,” she said of the raloxifene findings. “It might tip the scales for a lot of women.”

The new study means no change for premenopausal women — there’s no data showing whether raloxifene is safe for them, Dr. Albain said.

Nor does it mean that tamoxifen users should necessarily switch, she said.

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