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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.
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