Development and Application of Benefit/Risk Models for Chemoprevention Drugs

In recent years, the development of interventions to prevent cancer or detect cancer at an early stage has necessitated the development and application of benefit/risk indices for use by physicians, the general public, and population scientists. The Breast Cancer Prevention Trial (BCPT) showed a remarkable 49% reduction in invasive breast cancer among high-risk women taking the drug tamoxifen. Collaborating with investigators in the Division of Cancer Epidemiology and Genetics (DCEG), investigators in DCCPS developed a benefit/risk index to weigh the risks and benefits of taking tamoxifen for breast cancer chemoprevention. Investigators in the Division of Cancer Control and Population Sciences (DCCPS), in collaboration with DCEG and NCI's Division of Cancer Prevention (DCP), also used this benefit/risk index to estimate the numbers of women in the general US population who would be eligible and the numbers that would benefit from taking tamoxifen for chemoprevention. The recent STAR trial showed that the drug raloxifene may be as effective as tamoxifen at reducing invasive breast cancer in high-risk women, with possibly fewer side effects. Results of this study have prompted an effort led by DCCPS staff, in collaboration with DCEG, DCP, and University of Pittsburgh to develop a benefit/risk assessment model for the use of raloxifene in the chemoprevention of breast cancer.