Lung Cancer Among Postmenopausal Women Treated With Estrogen Alone in the Women's Health Initiative Randomized Trial

Lung Cancer Among Postmenopausal Women Treated With Estrogen Alone in the Women's Health Initiative Randomized Trial
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DOI:
10.1093/jnci/djq285
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发表时间:
2010-09-01
影响因子:
10.3
通讯作者:
Stefanick, Marcia L.
Stefanick, Marcia L.
中科院分区:
医学1区
文献类型:
--
作者:
Chlebowski, Rowan T.;Anderson, Garnet L.;Stefanick, Marcia L.

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在妇女健康倡议(WHI)的随机对照试验中,使用雌激素联合孕激素增加肺癌死亡率。我们进行了事后分析,在WHI试验评价雌激素单独使用,以确定是否使用共轭马雌激素没有residestin有类似的不良影响,对肺癌。方法WHI研究是一个随机,双盲,安慰剂对照试验,在美国的40个中心进行。共有10739名年龄在50-79岁之间的绝经后妇女接受了子宫切除术,她们被随机分配接受每日一次0.625 mg的结合型马雌激素片剂(n = 5310)或匹配的安慰剂(n = 5429)。使用风险比(HR)和95%置信区间(CI)比较两个随机分组中所有肺癌、小细胞肺癌和非小细胞肺癌的发病率和死亡率,风险比(HR)和95%置信区间(CI)由考克斯比例风险回归分析估计。通过意向治疗进行分析,所有统计检验均为双侧检验。(标准差= 1.8年)的随访中,激素治疗组有61名女性被诊断为肺癌,而安慰剂组有54名(肺癌年发病率分别为0.15%和0.13%;发病率的HR = 1.17,95%CI = 0.81至1.69,P = 0.39)。两组中非小细胞肺癌的数量、分期和分级相当。两组间肺癌死亡率无差异(雌激素组和安慰剂组分别为34例和33例;死亡HR = 1.07,95%CI = 0.66 - 1.72,P = 0.79)。结论与使用雌激素加炔雌醇增加肺癌死亡率不同,单独使用结合型马雌激素不会增加肺癌的发病率或死亡率。
Background In the Women's Health Initiative (WHI) randomized controlled trial, use of estrogen plus progestin increased lung cancer mortality. We conducted post hoc analyses in the WHI trial evaluating estrogen alone to determine whether use of conjugated equine estrogen without progestin had a similar adverse influence on lung cancer.Methods The WHI study is a randomized, double-blind, placebo-controlled trial conducted in 40 centers in the United States. A total of 10 739 postmenopausal women aged 50-79 years who had a previous hysterectomy were randomly assigned to receive a once-daily 0.625-mg tablet of conjugated equine estrogen (n = 5310) or matching placebo (n = 5429). Incidence and mortality rates for all lung cancers, small cell lung cancers, and non-small cell lung cancers in the two randomization groups were compared by use of hazard ratios (HRs) and 95% confidence intervals (CIs) that were estimated from Cox proportional hazards regression analyses. Analyses were by intention to treat, and all statistical tests were two-sided.Results After a mean of 7.9 years (standard deviation = 1.8 years) of follow-up, 61 women in the hormone therapy group were diagnosed with lung cancer compared with 54 in the placebo group (incidence of lung cancer per year = 0.15% vs 0.13%, respectively; HR of incidence = 1.17, 95% CI = 0.81 to 1.69, P = .39). Non-small cell lung cancers were of comparable number, stage, and grade in both groups. Deaths from lung cancer did not differ between the two groups (34 vs 33 deaths in estrogen and placebo groups, respectively; HR of death = 1.07, 95% CI = 0.66 to 1.72, P = .79).Conclusion Unlike use of estrogen plus progestin, which increased deaths from lung cancer, use of conjugated equine estrogen alone did not increase incidence or death from lung cancer.