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JNCI Journal of the National Cancer Institute 1999 91(21):1829-1846; doi:10.1093/jnci/91.21.1829
© 1999 by Oxford University Press
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Journal of the National Cancer Institute, Vol. 91, No. 21, 1829-1846, November 3, 1999
© 1999 Oxford University Press


SPECIAL ARTICLE

Weighing the Risks and Benefits of Tamoxifen Treatment for Preventing Breast Cancer

Mitchell H. Gail, Joseph P. Costantino, John Bryant, Robert Croyle, Laurence Freedman, Kathy Helzlsouer, Victor Vogel

Affiliations of authors: M. H. Gail (Division of Cancer Epidemiology and Genetics), R. Croyle (Division of Cancer Control and Population Science), National Cancer Institute, Bethesda, MD; J. P. Costantino, J. Bryant, University of Pittsburgh, PA; L. Freedman, Bar Illan University, Ramat Gan, Israel; K. Helzlsouer, The Johns Hopkins School of Hygiene and Public Health, Baltimore, MD; V. Vogel, University of Pittsburgh Cancer Institute/Magee Women's Hospital.

Correspondence to: Mitchell H. Gail, M.D., Ph.D., National Cancer Institute, EPS-8032, Rockville, MD 20892 (gailm{at}exchange.nih.gov).

BACKGROUND: In response to findings from the Breast Cancer Prevention Trial that tamoxifen treatment produced a 49% reduction in the risk of invasive breast cancer in a population of women at elevated risk, the National Cancer Institute sponsored a workshop on July 7 and 8, 1998, to develop information to assist in counseling and in weighing the risks and benefits of tamoxifen. Our study was undertaken to develop tools to identify women for whom the benefits outweigh the risks. METHODS: Information was reviewed on the incidence of invasive breast cancer and of in situ lesions, as well as on several other health outcomes, in the absence of tamoxifen treatment. Data on the effects of tamoxifen on these outcomes were also reviewed, and methods were developed to compare the risks and benefits of tamoxifen. RESULTS: The risks and benefits of tamoxifen depend on age and race, as well as on a woman's specific risk factors for breast cancer. In particular, the absolute risks from tamoxifen of endometrial cancer, stroke, pulmonary embolism, and deep vein thrombosis increase with age, and these absolute risks differ between white and black women, as does the protective effect of tamoxifen on fractures. Tables and aids are developed to describe the risks and benefits of tamoxifen and to identify classes of women for whom the benefits outweigh the risks. CONCLUSIONS: Tamoxifen is most beneficial for younger women with an elevated risk of breast cancer. The quantitative analyses presented can assist health care providers and women in weighing the risks and benefits of tamoxifen for reducing breast cancer risk.



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