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Impact of Raloxifene or Tamoxifen Use on Endometrial Cancer Risk: A Population-Based Case-Control Study

Angela DeMichele, Andrea B. Troxel, Jesse A. Berlin, Anita L. Weber, Greta R. Bunin, Elene Turzo, Rita Schinnar, Desiree Burgh, Michelle Berlin, Stephen C. Rubin, Timothy R. Rebbeck, Brian L. Strom

From the Departments of Biostatistics and Epidemiology, Medicine, and Obstetrics and Gynecology, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania; University of Pennsylvania School of Medicine; Abramson Cancer Center; and Children's Hospital of Philadelphia, Philadelphia, PA; and Johnson & Johnson Pharmaceutical Research and Development, Titusville, NJ

Corresponding author: Angela DeMichele, MD, MSCE, 14 Penn Tower, 3400 Spruce St, Philadelphia, PA 19104; e-mail: angela.demichele{at}uphs.upenn.edu

Purpose Raloxifene reduces breast cancer risk in women with osteoporosis, and both tamoxifen and raloxifene prevent breast cancer in high-risk women. However, in vitro, raloxifene does not share the pro-estrogenic effects of tamoxifen on the endometrium. Randomized trials of these agents have provided limited information about endometrial cancer risk in the general population. We sought to compare endometrial cancer risks associated with raloxifene, tamoxifen, and nonusers of a selective estrogen receptor modulator (SERM) in the general population and characterize the endometrial tumors occurring in these groups.

Methods We performed a case-control study of white and African American women age 50 to 79 years in the Philadelphia area. Patients were diagnosed with endometrial cancer between July 1999 and June 2002. Controls were identified through random-digit dialing.

Results We analyzed 547 cases and 1,410 controls. Among cases, 3.3% had taken raloxifene; 6.2% had taken tamoxifen. Among controls, 6.6% had taken raloxifene; 2.4% had taken tamoxifen. After adjustment for other risk factors, the odds of endometrial cancer among raloxifene users was 50% that of nonusers (odds ratio [OR] = 0.50; 95% CI, 0.29 to 0.85), whereas tamoxifen users had three times the odds of developing endometrial cancer compared with raloxifene users (OR = 3.0; 95% CI, 1.3 to 6.9). Endometrial tumors in raloxifene users had a more favorable histologic profile and were predominantly International Federation of Gynecology and Obstetrics stage I and low grade.

Conclusion Raloxifene users had significantly lower odds of endometrial cancer compared with both tamoxifen users and SERM nonusers, suggesting a role for raloxifene in endometrial cancer prevention and individualization of SERM therapy.

Supported by the National Cancer Institute, National Institutes of Health, Grant No. P01-CA77596.

A.D. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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