Guidelines for Tamoxifen and Raloxifene

Two Canadian healthcare groups have just issued guidelines for women considering whether tamoxifen or raloxifene might reduce their risk of developing breast cancer. The two groups-the Canadian Task Force on Preventive Health Care, and the Canadian Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer-published their recommendations in the Canadian Medical Association Journal.

Specifically, they relied on a woman's score from the so-called Gail Model for assessing breast cancer risk.

In 1990, Dr. Mitchell Gail, a researcher from the National Cancer Institute, developed a mathematical model to help predict breast cancer risk. The Gail Model incorporates seven key factors: age, race, number of first degree relatives with a history of breast cancer, age at first live birth, age at menarche (first period), number of breast biopsies, and a history of atypical hyperplasia.

Although it has been modified somewhat over the past decade, the Gail Model is still the predominant tool used to determine breast cancer risk for women in the general population. Importantly, it is also a major guideline used for enrolling patients in the Study of Tamoxifen and Raloxifene (STAR) clinical trial.

The Canadian groups recommended that for women with a Gail risk assessment of less that 1.66% at 5 years, tamoxifen preventive therapy is not recommended. For women with a Gail risk assessment of 1.66% or greater at 5 years, the pros and cons of tamoxifen preventive therapy should be weighed by each woman based on potential benefits and risks.

The groups also recommended that raloxifene probably should not be used for breast cancer prevention outside of approved clinical trials until the STAR trial and other ongoing studies are completed. SOURCES:
Canadian Medical Association Journal, June 12, 2001; 164:1681-1690

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