Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures - The Women's Health Initiative randomized trial
Effects of estrogen plus progestin on gynecologic cancers and associated diagnostic procedures - The Women's Health Initiative randomized trial
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DOI：
10.1001/jama.290.13.1739
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发表时间：
2003-10-01
影响因子：
120.7
通讯作者：
Lopez, AM
中科院分区：
文献类型：
--
作者：
Anderson, GL;Judd, HL;Lopez, AM
目的确定雌激素和孕激素在妇科癌症和相关诊断程序中的可能关联。设计、设置和参与者随机、双盲、安慰剂对照试验16608名绝经后妇女在1993年9月至1998年10月期间从40个美国临床中心招募(平均随访，结果：随访5.6年，卵巢浸润性癌32例，子宫内膜癌58例，非子宫内膜癌1例，非子宫内膜癌1例，宫颈癌13例，其他妇科肿瘤7例。与安慰剂相比，服用雌激素和孕激素的女性患浸润性卵巢癌的风险比(HR)为1.58(95%可信区间[CI]，0.77-3.24)。子宫内膜癌的HR为0.81(95%CI，0.48~1.36)。在两个肿瘤部位的肿瘤组织学、分期或分级分布上没有明显的差异。其他妇科癌症的发病率很低，通过随机分配没有差别。更多服用雌激素和孕激素的妇女需要进行子宫内膜活检(33%vs6%；P
Context The effects of continuous combined hormone therapy on gynecologic cancers have not been investigated previously in a randomized trial setting.Objective To determine the possible associations of estrogen plus progestin on gynecologic cancers and related diagnostic procedures.Design, Setting, and Participants Randomized, double-blind, placebo-controlled trial of 16608 postmenopausal women, who had not had a hysterectomy at baseline and who had been recruited from 40 US clinical centers between September 1993 and October 1998 (average follow-up, 5.6 years).Intervention One tablet per day containing 0.625 mg of conjugated equine estrogens plus 2.5 mg of medroxyprogesterone acetate (n=8506) or placebo (n=8102).Main Outcome Measure Incident invasive cancer of the ovary and endometrium.Results In 5.6 years of follow-up, there were 32 cases of invasive ovarian cancer, 58 cases of endometrial cancer, 1 case of nonendometrial uterine cancer, 13 cases of cervical cancer, and 7 cases of other gynecologic cancers. The hazard ratio (HR) for invasive ovarian cancer in women assigned to estrogen plus progestin compared with placebo Was 1.58 (95% confidence interval [CI], 0.77-3.24). The HR for endometrial cancer was 0.81 (95% Cl, 0.48-1.36). No appreciable differences were found in the distributions of tumor histology, stage, or grade for either cancer site. The incidence of other gynecologic cancers was low and did not differ by randomization assignment. More women taking estrogen plus progestin required endometrial biopsies (33% vs 6%; P