RESPONSE: Re: Italian Randomized Trial Among Women With Hysterectomy: Tamoxifen and Hormone-Dependent Breast Cancer in High-Risk Women
Abstract
We concluded our recent publication (1) by noting that the effect of tamoxifen in chemoprevention appeared to be restricted to women predicted to be at high risk of the hormone-dependent form of the disease. We identified a subgroup of women in the Italian Randomized Trial of Tamoxifen at high risk of estrogen receptor (ER)-positive breast cancer on the basis of baseline measurements and emphasized that these results require confirmation from other trials before the clinical and public health implications are clear (1). We still believe this to be the case. Narasimhadevara et al. make some interesting points; notably, that we did not attempt to identify a subgroup at high risk of ER-negative breast cancer. When we investigated the role of the hormonal variables as risk factors, none of the variables in Table 1 of our original article (1) (i.e., use of hormone replacement therapy, height, ovary function, age at menarche, age at first birth) were statistically significantly associated with the risk of ER-negative breast cancer in the study cohort. Only breast cancer in a first-degree relative (odds ratio = 2.6, 95% confidence interval = 0.8 to 8.1) approached statistical significance. We agree that ER-negative breast cancer is a very important form of breast cancer and one that deserves a great deal of attention, especially in terms of prevention, both primary prevention and chemoprevention. However, it is counter intuitive to expect hormonal interventions with agents such as…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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