Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy

Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy
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DOI:
10.1001/jama.295.14.1647
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发表时间:
2006-04-12
影响因子:
120.7
通讯作者:
Chlebowski, RT
Chlebowski, RT
中科院分区:
医学1区
文献类型:
--
作者:
Stefanick, ML;Anderson, GL;Chlebowski, RT

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背景:妇女健康倡议雌激素-一项比较结合马类雌激素(CEE)和安慰剂的试验因中风发病率增加和冠心病风险没有降低而提前停止。初步结果表明乳腺癌的可能减少需要更详细的分析。目的确定CEE对乳腺癌和乳房X光检查的影响。设计、设置和参与者在乳腺癌风险评估后,从1993年到1998年,在40个美国临床中心,10739名年龄在50岁到79岁之间的绝经后妇女被随机分为CEE组和安慰剂组。在基线和每年进行乳房X光检查和临床乳房检查。结果经过平均7.1年(1.6年)的随访期(SD),CEE组和安慰剂组的浸润性乳腺癌风险比(HR)为0.80(95%可信区间[CI],0.62-1.04;P=.09),年化比率为0.28%(CEE组104例)和0.34%(安慰剂组133例)。在探索性分析中,与安慰剂组相比,CEE组的导管癌(HR,0.71;95%CI,0.52-0.99)减少;然而,肿瘤类型的交互作用检验并不显著(P=.054)。在1年时,CEE组9.2%的女性有异常的乳房X光检查需要随访,而安慰剂组为5.5%(P<.001),这一模式在整个试验中持续到累积百分比分别为36.2%和28.1%(P<.001);然而,这种差异主要是在需要短时间随访的评估方面。结论:在绝经后有过子宫切除术的女性中,单独接受CEE治疗7.1年并不会增加乳腺癌的发生率。然而,CEE的治疗增加了需要短时间随访的乳房X光检查的频率。启动CEE应以考虑妇女个人的潜在风险和利益为基础。
Context The Women's Health Initiative Estrogen-Aone trial comparing conjugated equine estrogens (CEE) with placebo was stopped early because of an increased stroke incidence and no reduction in risk of coronary heart disease. Preliminary results suggesting possible reduction in breast cancers warranted more detailed analysis.Objective To determine the effects of CEE on breast cancers and mammographic findings.Design, Setting, and Participants Following breast cancer risk assessment, 10 739 postmenopausal women aged 50 to 79 years with prior hysterectomy were randomized to CEE or placebo at 40 US clinical centers from 1993 through 1998. Mammography screenings and clinical breast examinations were performed at baseline and annually. All breast cancers diagnosed through February 29, 2004, are included.Intervention A dose of 0.625 mg/d of CEE or an identical-appearing placebo.Main Outcome Measures Breast cancer incidence, tumor characteristics, and mammogram findings.Results After a mean (SD) follow-up of 7.1 (1.6) years, the invasive breast cancer hazard ratio (HR) for women assigned to CEE vs placebo was 0.80 (95% confidence interval [CI], 0.62-1.04; P = .09) with annualized rates of 0.28% (104 cases in the CEE group) and 0.34% (133 cases in the placebo group). In exploratory analyses, ductal carcinomas (HR, 0.71; 95% CI, 0.52-0.99) were reduced in the CEE group vs placebo group; however, the test for interaction by tumor type was not significant (P = .054). At 1 year, 9.2% of women in the CEE group had mammograms with abnormalities requiring follow-up vs 5.5% in the placebo group (P < .001), a pattern that continued through the trial to reach a cumulative percentage of 36.2% vs 28.1%, respectively (P < .001); however, this difference was primarily in assessments requiring short interval follow-up.Conclusions Treatment with CEE alone for 7.1 years does not increase breast cancer incidence in postmenopausal women with prior hysterectomy. However, treatment with CEE increases the frequency of mammography screening requiring short interval follow-up. Initiation of CEE should be based on consideration of the individual woman's potential risks and benefits.