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Re: Italian Randomized Trial Among Women With Hysterectomy: Tamoxifen and Hormone-Dependent Breast Cancer in High-Risk Women

Sylvie Ménard, Patrizia Casalini, Elena Tagliabue, Serenella Maria Pupa, Andrea Balsari

JNCI Journal of the National Cancer Institute, 2003

Abstract

In their recent paper, Veronesi et al. (1) reported that women, divided into two groups according to their risk of developing breast carcinomas, respond differently to the preventive effect of tamoxifen. In addition to the impressive reduction of tumors obtained with tamoxifen among women in the high-risk group, the study gives important epidemiologic information: 1) hormone replacement therapy (HRT) appears to be a risk factor for breast carcinoma only for women at high risk, suggesting that an early hormone exposure (early menarche, nulliparity, late age at first pregnancy, intact ovarian function) predisposes these women to an additional risk resulting from subsequent hormone exposure. By contrast, among women at low risk for breast carcinoma, HRT did not seem to be associated with a substantially increased risk. 2) For most of the risk factors analyzed in these hysterectomized patients, Veronesi et al. (1) report odds ratios that are notably higher than those reported in the general population (2). If not a result of the relatively low number of patients analyzed, the impact of hormone exposure might be a result of a particularly low risk among this hysterectomized group. Accordingly, considering all the tumors, the frequency of estrogen receptor (ER)-negative tumors is higher than expected, suggesting a baseline protection of ER-positive tumors. Moreover, in contrast with a previous report indicating a prevalence of ER-positive tumors in high-risk patients (3), the…

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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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