Objective: To conduct an evidence-based technology assessment to determine whether tamoxifen and raloxifene as breast cancer risk-reduction strategies are appropriate for broad-based conventional use in clinical practice. Potential Intervention: Tamoxifen and raloxifene. Outcome: Outcomes of interest include breast cancer incidence, breast cancer-specific survival, overall survival, and net health benefits. Evidence: A comprehensive,formal literature review was conducted for tamoxifen and raloxifene on the following topics: breast cancer risk reduction; tamoxifen side effects and toxicity, including endometrial cancer risk; tamoxifen influences on nonmalignant diseases, including coronary heart disease and osteoporosis; and decision making by women at risk for breast cancer. Testimony was collected from invited experts and interested parties. Values: More weight was given to publications that described randomized trials. Benefits/Harms/Costs: The American Society of Clinical Oncology (ASCO) Working Group acknowledges that a woman's decision regarding breast cancer risk-reduction strategies will depend on the importance and weight attributed to the information provided regarding both cancer and non-cancer-related risks. Conclusions: For women with a defined 5-year projected risk of breast cancer of greater than or equal to 1.66%, tamoxifen (at 20 mg/d for vp to 5 years) may be offered to reduce their risk. It is premature to recommend raloxifene use to lower the risk of developing breast cancer outside of a clinical trial setting. On the basis of available information, use of raloxifene should currently be reserved for its approved indication ta prevent bone loss in postmenopausal women. Conclusions are based on single-agent use of the drugs. Al the present time, the effect of using tamoxifen or raloxifene with other medications (such as hormone replacement therapy), or using tamoxifen and raloxifene in combination or sequentially, has not been studied adequately. The continuing use of placebo-controlled trials in other risk-reduction trials highlights the current unanswered issues concerning the use of such interventions, especially when the influence on net health benefit remains ta be determined. Breast cancer risk reduction is a rapidly evolving area. This technology assessment represents an ongoing process with existing plans Po monitor and review data and to update recommendations in a timely matter. (See Table 1 for a summary of conclusions.) Validations: The conclusions of the Working Group were evaluated by the ASCO Health Services Research Committee and by the ASCO Board of Directors. Sponsor: American Society of Clinical Oncology. (C) 1999 by American Society of Clinical Oncology.
