Colorectal cancer in relation to postmenopausal estrogen and estrogen plus progestin in the Women's Health Initiative clinical trial and observational study.
Colorectal cancer in relation to postmenopausal estrogen and estrogen plus progestin in the Women's Health Initiative clinical trial and observational study.
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DOI：
10.1158/1055-9965.epi-08-1209
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发表时间：
2009-05
期刊：
影响因子：
--
通讯作者：
Chlebowski RT
中科院分区：
文献类型：
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作者：
Prentice RL;Pettinger M;Beresford SA;Wactawski-Wende J;Hubbell FA;Stefanick ML;Chlebowski RT
在妇女健康倡议（WHI）雌激素加孕酮随机试验中，分配到积极治疗的妇女中结直肠癌发病率降低，但相关的后期诊断模糊了解释。相反，单独雌激素试验显示发病率没有降低或诊断时的分化阶段。在这里，来自WHI观察性研究的数据被认为是与来自激素治疗试验的结直肠癌死亡率数据相结合，试图澄清绝经后激素治疗的效果。WHI入组时年龄为50 - 79岁的绝经后女性。单独雌激素分析分别包括观察性研究和临床试验中21，552名和10，739名子宫切除术后的女性。雌激素加孕酮分析包括32，084和16，608名观察性研究和临床试验子宫妇女。通过中心医学和病理学报告审查验证结直肠癌。来自WHI观察性研究的风险比（95%置信区间）为雌激素0.80（0.53至1.20），雌激素加孕酮1.15（0.74至1.79），分别有168和175名妇女诊断为结直肠癌。在观察性研究中，雌激素加孕酮的延迟诊断并不明显。在为期8年的干预和随访期内，雌激素加孕酮试验对结直肠癌死亡率没有保护作用。WHI临床试验和观察性研究中的风险比模式并没有提供强有力的证据表明，在7 - 8年的治疗和随访中，单独使用雌激素或雌激素加炔雌醇具有临床重要的结直肠癌益处。
Colorectal cancer incidence was reduced among women assigned to active treatment in the Women's Health Initiative (WHI) estrogen plus progestin randomized trial, but the interpretation was obscured by an associated later stage of diagnosis. In contrast the estrogen-alone trial showed no incidence reduction or differential stage at diagnosis. Here, data from the WHI observational study are considered, in conjunction with colorectal cancer mortality data from the hormone therapy trials, in an attempt to clarify postmenopausal hormone therapy effects. Postmenopausal women aged 50−79 at WHI enrollment. Estrogen-alone analyses include 21,552 and 10,739 women who were post-hysterectomy from the observational study and clinical trial respectively. Estrogen plus progestin analyses include 32,084 and 16,608 observational study and clinical trial women with uterus. Colorectal cancers were verified by central medical and pathology report review. Hazard ratios (95% confidence intervals) from the WHI observational study were 0.80 (0.53 to 1.20) for estrogen and 1.15 (0.74 to 1.79) for estrogen plus progestin, with respectively 168 and 175 women diagnosed with colorectal cancer. Delayed diagnosis with estrogen plus progestin is not evident in the observational study. No protective effect on colorectal cancer mortality in the estrogen plus progestin trial is seen over an 8-year intervention and follow-up period. Hazard ratio patterns in the WHI clinical trial and observational study do not provide strong evidence of a clinically important colorectal cancer benefit with either estrogen-alone or estrogen plus progestin over 7−8 years of treatment and follow-up.