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Effect of Raloxifene on the Incidence of Invasive Breast Cancer in Postmenopausal Women with Osteoporosis Categorized by Breast Cancer Risk

Authors' Affiliations: ¹ Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan; ² San Francisco Coordinating Center, California Pacific Medical Center Research Institute, San Francisco, California; ³ Lilly Corporate Center, Eli Lilly & Company, Indianapolis, Indiana; ⁴ Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pennsylvania; and ⁵ The Angeles Clinic and Research Institute, Santa Monica, California

Requests for reprints: Marc E. Lippman, Department of Internal Medicine, University of Michigan, 3101 Taubman Center, Box 0368, 1500 East Medical Center Drive, Ann Arbor, MI 48109. Phone: 734-936-4495; Fax: 734-615-2645; E-mail: lippmanm{at}umich.edu, or Sherie A. Dowsett, Lilly Corporate Center, Eli Lilly & Company, Indianapolis, IN 46285. E-mail: dowsettsa{at}Lilly.com.

Purpose: To assess the effect of raloxifene, indicated for osteoporosis treatment and prevention, on invasive breast cancer in subgroups of postmenopausal women defined by risk factors for breast cancer.

Experimental Design: Data from the 4-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial (N = 7,705) and a follow-up study, the 4-year Continuing Outcomes Relevant to Evista (CORE) trial (N = 4,011), were analyzed. Prespecified subgroups were defined by age (65 versus <65 years), age at menopause (49 versus <49 years), body mass index (25 versus <25 kg/m²), family history of breast cancer (yes/no), serum estradiol level (5-10 versus <5, >10 versus <5 pmol/L), prior estrogen therapy (yes/no), and bone mass at MORE baseline, and 5-year predicted risk, assessed using the modified Gail model (1.67 versus <1.67%), at CORE baseline. Time-to-first invasive breast cancer was analyzed using Cox proportional hazards models.

Results: In the placebo group, older age, higher estradiol level, and a family history of breast cancer were associated with an increased breast cancer risk (P < 0.05). Raloxifene therapy was associated with a reduced breast cancer risk in both women at lower and those at higher breast cancer risk. Hazard ratio point estimates were 0.11 to 0.67, corresponding to a 33% to 89% reduction in breast cancer risk with raloxifene versus placebo. The therapy by family history interaction was significant (P = 0.04).

Conclusions: Raloxifene therapy was associated with a reduced risk of invasive breast cancer in postmenopausal women irrespective of the presence/absence of risk factors; its effect was greater in women with a family history of breast cancer.

Commentary

The Science of Selective Estrogen Receptor Modulators: Concept to Clinical Practice

V. Craig Jordan
Clin. Cancer Res. 2006 12: 5010-5013. [Full Text] [PDF]

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				V. C. Jordan The Science of Selective Estrogen Receptor Modulators: Concept to Clinical Practice Clin. Cancer Res., September 1, 2006; 12(17): 5010 - 5013. [Full Text] [PDF]