Vassilopoulou-Sellin Rena, Cohen Deborah S, Hortobagyi Gabriel N, Klein Mary Jean, McNeese Marsha, Singletary S Eva, Smith Terry L, Theriault Richard L
Department of Endocrine Neoplasia and Hormonal Disorders, The University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
Cancer. 2002 Nov 1;95(9):1817-26. doi: 10.1002/cncr.10913.
Women with a history of breast carcinoma generally have been advised to avoid estrogen replacement therapy (ERT). The validity of this approach has been scrutinized and debated in recent years, and reassessment through appropriate clinical trials has been suggested.
The authors conducted a prospective clinical trial to assess the safety and efficacy of prolonged ERT in a group of menopausal women with localized (Stage I or Stage II) breast carcinoma and a minimum disease free interval of 2 years if estrogen receptor (ER) was negative or 10 years if ER status was unknown. For 5 years, the authors followed 77 trial participants and 222 other women with clinical and prognostic characteristics comparable to those of the trial participants. Overall, 56 women were on ERT, and 243 women were not on ERT. The association of ERT with skeletal and lipid changes was assessed in the randomized trial participants. The effect of ERT on the development of recurrent or new breast carcinoma and other carcinomas was analyzed both in the trial participants and in the overall group.
Patient and disease characteristics, such as tumor size, number of lymph nodes involved, ER status, menopausal status, and disease free interval were comparable for women who were on ERT and women who were not on ERT. These same parameters also were comparable for women who joined the trial and women who did not. ERT use was associated with modest lipid and skeletal benefits. The introduction of ERT did not compromise disease free survival. Two of 56 women on ERT (3.6%) developed a contralateral, new breast carcinoma. In the group that was not on ERT, 33 of 243 women (13.5%) developed new or recurrent breast carcinoma. There were no differences in the development of other carcinomas with respect to ERT.
ERT did not compromise disease free survival in select patients who were treated previously for localized breast carcinoma. Larger scale randomized trials are needed to confirm these findings.
有乳腺癌病史的女性通常被建议避免雌激素替代疗法（ERT）。近年来，这种方法的有效性受到了仔细审查和辩论，并有人建议通过适当的临床试验进行重新评估。
作者进行了一项前瞻性临床试验，以评估长期ERT在一组绝经后局部（I期或II期）乳腺癌女性中的安全性和有效性，若雌激素受体（ER）为阴性，则无病间隔至少2年；若ER状态未知，则无病间隔至少10年。作者对77名试验参与者以及222名具有与试验参与者相似临床和预后特征的其他女性进行了5年的随访。总体而言，56名女性接受ERT治疗，243名女性未接受ERT治疗。在随机试验参与者中评估ERT与骨骼和脂质变化的关联。在试验参与者和整个组中分析ERT对复发性或新发乳腺癌及其他癌症发生的影响。
接受ERT治疗的女性和未接受ERT治疗的女性在患者和疾病特征方面，如肿瘤大小､受累淋巴结数量､ER状态､绝经状态和无病间隔等方面具有可比性。参与试验的女性和未参与试验的女性在这些相同参数上也具有可比性。使用ERT与适度的脂质和骨骼益处相关。ERT的使用并未损害无病生存期。56名接受ERT治疗的女性中有2名（3.6%）发生了对侧新发乳腺癌。在未接受ERT治疗的组中，243名女性中有33名（13.5%）发生了新发或复发性乳腺癌。在其他癌症的发生方面，ERT没有差异。
ERT在先前接受局部乳腺癌治疗的特定患者中并未损害无病生存期。需要更大规模的随机试验来证实这些发现。
