Antoine Caroline, Liebens Fabienne, Carly Birgit, Pastijn Anne, Rozenberg Serge
Department of Obstetrics and Gynaecology, Free Universities of Brussels (VUB-ULB) CHU Saint-Pierre, Hoogstrasse 322, 1000 Brussels, Belgium.
Hum Reprod. 2004 Mar;19(3):741-56. doi: 10.1093/humrep/deh112. Epub 2004 Jan 29.
Mortality due to breast cancer has been reported to be the same or even lower in HRT users than in non-users. This has been attributed to earlier diagnosis and to better prognosis. Nevertheless, more advanced disease in HRT users was reported recently by the Women's Health Initiative (WHI) study. The objective of this study was to assess, using a systematic review of current literature, whether the data of the WHI study are in contradiction to observational data.
We selected 25 studies, for which we evaluated the methodology, the characteristics of the studied populations, confounding breast cancer risk factors and prognostic indicators.
The WHI study, showing a worsening of some prognostic parameters, is in contradiction to most published observational studies. Most observational studies are retrospective, not well matched and did not consider most confounding factors. Their methodology and selection criteria varied considerably and the number of patients was often small. No differences in the distributions of histology, grade or steroid receptors were observed in the WHI trial, while this was the case in some of the observational studies. Other parameters (S phase, protein Neu, Bcl-2 gene, protein p53 and E-cadherin, cathepsin D) were not reported in the WHI trial.
In view of these data, the current clinical message to patients should be changed: one can no longer declare that breast cancers developed while using HRT are of better prognosis.
据报道,激素替代疗法(HRT)使用者因乳腺癌导致的死亡率与非使用者相同甚至更低。这归因于早期诊断和更好的预后。然而,妇女健康倡议(WHI)研究最近报告称,HRT使用者中存在更晚期的疾病。本研究的目的是通过对当前文献的系统综述来评估WHI研究的数据是否与观察性数据相矛盾。
我们选择了25项研究,对其方法、研究人群的特征、混淆乳腺癌风险因素和预后指标进行了评估。
WHI研究显示一些预后参数恶化,这与大多数已发表的观察性研究相矛盾。大多数观察性研究是回顾性的,匹配不佳且未考虑大多数混淆因素。它们的方法和选择标准差异很大,患者数量通常较少。在WHI试验中未观察到组织学、分级或类固醇受体分布的差异,而在一些观察性研究中则存在这种情况。其他参数(S期、蛋白Neu、Bcl-2基因、蛋白p53和E-钙黏蛋白、组织蛋白酶D)在WHI试验中未报告。
鉴于这些数据,目前向患者传达的临床信息应有所改变:不能再宣称在使用HRT期间发生的乳腺癌预后更好。