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Although the Food and Drug Administration has made tamoxifen the first drug to be approved for the prevention of breast cancer, few physicians have been prescribing it for this purpose. Now, a statistical modeling study by Drs. Dawn Hershman and Victor R. Grann of the Herbert Irving Comprehensive Cancer Center at Columbia Presbyterian Medical Center of NewYork-Presbyterian Hospital confirms that for women who are at "very high risk" for breast cancer there is a benefit from tamoxifen for primary prevention, and that for these women, chemoprevention with the drug is cost-effective.

The study, led by researchers at Columbia University's College of Physicians & Surgeons and the Joseph L. Mailman School of Public Health, is published in the January 1 issue of Journal of Clinical Oncology. The researchers used data from a variety of sources to simulate a population of women at very high risk for breast cancer. They used data from the Breast Cancer Prevention Trial (BCPT) of the National Surgical Adjuvant Breast and Bowel Project, which involved 13,388 women, and the Surveillance, Epidemiology, and End-Results program, time trade-off preference ratings, the Group Health Cooperative of Puget Sound, and Medicare.

Using a mathematical method known as Markov modeling, the researchers found that women in the study who initiated tamoxifen use at ages 35, 50, or 60 years would survive an average of 70, 42, and 27 days longer than those in the study population who did not.

"We hypothesized that for women with a very high risk of invasive breast cancer, treatment with tamoxifen could extend quality of life and is shown to be cost-effective care," says Dr. Hershman, assistant professor of medicine at Columbia University College of Physicians & Surgeons. Indeed, the researchers found that tamoxifen prolonged average survival among the "very high risk" by 202, 89, and 45 days, respectively.

The researchers in the study deemed women to be at high risk for breast cancer if they had been diagnosed with the following conditions:

• Two or more first-degree relatives who have had breast cancer.
• Atypical hyperplasia—a pathologic finding on biopsy, indicating not cancer, but an increased risk of breast cancer.
• Lobular carcinoma-in-situ (LCIS)—likewise, a pathologic finding on biopsy indicating an increased risk of breast cancer.
• Gail Model Risk greater than five—a mathematical model based on such factors as age of beginning menstruating, age of menopause, whether one has ever been pregnant, and age of first pregnancy.

The researchers concluded that women at high-risk of breast cancer should feel comfortable about taking tamoxifen or enrolling in the latest clinical trial for chemoprevention, the Study of Tamoxifen and Raloxifene (STAR). This conclusion was reiterated by Drs. Craig Jordan and Monica Morrow in an accompanying editorial published in the Journal. The STAR trial will be the largest breast cancer prevention study ever, and will determine whether raloxifene (Evista), an osteoporosis prevention drug, is as effective in preventing breast cancer as tamoxifen. The Herbert Irving Comprehensive Cancer Center at Columbia is an active participant in this trial (212-305-6297).

The other authors of the article are Vijaya Sundararajan of Monash University in Australia, and Judith S. Jacobson, Daniel F. Heitjan, and Alfred I. Neugut of Columbia University. The study was supported in part by grants from the American Cancer Society; the Sindab African American Breast Cancer Project; the Avon Breast Cancer Research and Care Program; the Breast Cancer Alliance; and the National Cancer Institute (NCI). Dr. Hershman was the recipient of an NCI-funded postdoctoral fellowship.