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• W2106937460 abstract "The selective estrogen receptor modulators (SERMs), e.g., tamoxifen and raloxifene, represent an exciting new class of therapeutic agents, which may prove to be effective against a wide variety of conditions, including breast cancer, osteoporosis, and potentially other conditions. There are two principal limitations to the use of the currently available SERMs. First, the specificity of the mix of agonist and antagonist actions is limited. Newer agents with greater specificity hold the promise for highly targeted therapeutic actions with fewer undesirable side effects. Second, clinical trial data showing which populations benefit or suffer excessive risk from treatment with SERMs are very limited. It is with respect to this second limitation that Gail et al. (1), reporting in this issue of the Journal, have proposed estimates of benefits and risk for the use of tamoxifen for the prevention of breast cancer. The authors use data, based primarily on the Breast Cancer Prevention Trial (BCPT) (2), to construct guidelines to assess the benefits and risks of tamoxifen therapy for use in counseling women at risk for breast cancer. In this trial, 13 388 women at increased risk for breast cancer (projected absolute risk of at least 1.66% over 5 years) were randomly assigned to treatment with either tamoxifen or placebo and followed for an average period of 4.1 years. Tamoxifen was associated with an overall 49% reduction in risk of invasive breast cancer. However, increased risks of endometrial cancer, stroke, pulmonary embolism, and deep venous thrombosis were noted with tamoxifen, with relative risks of 2.53, 1.59, 3.01, and 1.60, respectively, compared with placebo. The authors estimated the reduction in risk of invasive breast cancer as well as the increases in risk of endometrial cancers, stroke, venous thromboembolic events, and fractures associated with tamoxifen treatment. The relative risk versus benefit of tamoxifen treatment for a woman of a given age and ethnicity was derived from the BCPT data in combination with background incidences of each condition derived from population-based surveys, hospital discharge databases, and death certificate databases. Risk/benefit assessment of any therapeutic tool is an extremely important process, particularly when a preventive care strategy is to be recommended, because most therapies have beneficial effects coupled with potentially harmful side effects. Risks and benefits to a population from any therapy may differ substantially, depending on age, concomitant illnesses and treatments, ethnicity, socioeconomic status, educational level, living environment, and health behaviors of the population. Therefore, the efforts of Gail et al. are commendable. Furthermore, the BCPT is a formidable database upon which to draw in formulating guidelines." @default.
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• W2106937460 title "Re: Risk/Benefit Assessment of Tamoxifen to Prevent Breast Cancer--Still a Work in Progress?" @default.
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• W2106937460 doi "https://doi.org/10.1093/jnci/92.7.574" @default.
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