Bone Thinning Drug Raloxifene As Effective As Tamoxifen In Reducing Postmenopausal Women's Risk Of Breast Cancer, NCI Study Says

The bone thinning drug raloxifene is as effective as the breast cancer prevention drug tamoxifen in reducing breast cancer risk for postmenopausal women already at an increased risk of developing the disease and is less likely to cause serious complications, according to initial results of a National Cancer Institute-sponsored study released on Monday, the Washington Post reports (Stein, Washington Post, 4/18). FDA in 1998 approved tamoxifen -- sold under the brand name Nolvadex by AstraZeneca -- to reduce breast cancer risk after a study showed it decreased the likelihood of women developing the disease by 50%. It is the only drug the agency has approved for such use, the Detroit News reports. Raloxifene, sold under the brand name Evista and made by Eli Lilly, is FDA approved for use as a preventive drug for osteoporosis and bone thinning but not for breast cancer (Kozlowski, Detroit News, 4/18). Both drugs are designed to block estrogen -- which stimulates many breast cancer tumors -- and both have comparable side-effect risks, including an increased risk of blood clot, the Wall Street Journal reports (Corbett Dooren, Wall Street Journal, 4/18). Eli Lilly plans to seek FDA approval for use of raloxifene to prevent breast cancer, the AP/Akron Beacon Journal reports (Neergaard, AP/Akron Beacon Journal, 4/17).

Study Results
For the study, researchers at the NCI-sponsored National Surgical Adjuvant Breast and Bowel Project enrolled 19,747 postmenopausal women who had an average age of 58 and an average risk of 4% of developing breast cancer, compared with a 1.6% risk for the total population in the same age range (Maugh, Los Angeles Times, 4/18). Researchers determined each woman's breast cancer risk through an analysis of a questionnaire available at breastcancerprevention, and the participants randomly were assigned to take tamoxifen or raloxifene for five years (Grady, New York Times, 4/18). The study, which followed the participants for an average of four years, finds that both drugs reduced breast cancer risk by about 50%, with 167 of the 9,745 women in the raloxifene group developing breast cancer and 163 of the 9,726 women in the tamoxifen group developing the disease (NCI release, 4/17). Participants in the raloxifene group had a higher number of precancerous lesions than women in the tamoxifen group, Reuters reports (Fox, Reuters, 4/17). The study also finds that women in the raloxifene group developed 36% fewer uterine cancers, 29% fewer blood clots and were less likely to develop cataracts requiring surgery or have night sweats, hot flashes and gynecological irritation than women in the tamoxifen group (Bor, Baltimore Sun sidebar, 4/18). The cataract difference was statistically significant, but the differences in uterine cancers, blood clots and menopausal symptoms were not statistically significant, the Times reports (New York Times, 4/18). "This is really good news for women," Leslie Ford, a study co-author and NCI researcher, said, adding that raloxifene is a "drug that's already used by 500,000 women for treatment and prevention of osteoporosis, and now we have an additional benefit" (Goldstein, Miami Herald, 4/18). The researchers plan to present additional data from the study at the American Society for Clinical Oncology meeting in June (Collins, Salt Lake City Deseret Morning News, 4/18).

Media Coverage
Several broadcast programs reported on the study:
ABCNews' "World News Tonight": The segment includes comments from Mary Daly, director of the Margaret Dyson Family Risk Assessment Program and director of the Cancer Prevention and Control Program at the Fox Chase Cancer Center; Judy Garber, director of cancer risk and prevention in the Department of Adult Oncology at the Dana-Farber Cancer Institute; Norman Wolmark, chair of NSABP; and a woman who participated in the study (McKenzie, "World News Tonight," ABCNews, 4/17).

CBS' "Evening News": The segment includes comments from Ford and a woman who participated in the study (Kaledin, "Evening News," CBS, 4/17). The complete segment is available online in RealPlayer.

NBC's "Nightly News": The segment includes comments from Ford, Wolmark and a woman who participated in the study (Bazell, "Nightly News," NBC, 4/17). The complete segment is available online in Windows Media.

NPR's "All Things Considered": The segment includes comments from Garnet Anderson, faculty member at the Fred Hutchinson Cancer Research Center; Joy Melnikow, a professor of family and community medicine at the University of California-Davis; Wolmark; and women who participated in the study (Palca, "All Things Considered," NPR, 4/17). A transcript of the segment is available online. The complete segment is available online in RealPlayer.















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View drug information on Evista; Nolvadex.