Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort
Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort
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DOI：
10.1016/s1470-2045(10)70268-0
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发表时间：
2011-01-01
期刊：
影响因子：
51.1
通讯作者：
Menon, Usha
中科院分区：
文献类型：
--
作者：
Jacobs, Ian;Gentry-Maharaj, Aleksandra;Menon, Usha
世界范围内子宫内膜癌发病率的增加与肥胖增加、生育率下降和人口老龄化有关。经阴道超声（TVS）是一种可能的筛查试验，但尚未有大规模的研究。我们在一个大的队列中报告了TVS筛查的表现。方法：我们对2001年4月17日至2005年9月29日期间在英国卵巢癌筛查合作试验（UKCTOCS）中接受TVS的绝经后妇女进行了巢式病例对照研究。记录子宫内膜厚度和子宫内膜异常，并通过国家登记和邮寄问卷进行随访，记录子宫内膜癌的诊断。我们的主要结局指标是子宫内膜癌和非典型子宫内膜增生（AEH）。计算TVS患者1年内子宫内膜厚度表现特征及子宫内膜癌诊断异常情况。流行病学变量用于建立逻辑回归模型，并评估高风险妇女的筛查策略。我们的研究已在ClinicalTrials.gov注册，编号为NCT00058032，并在国际标准随机对照试验注册，编号为ISRCTN22488978。发现48230名妇女在UKCTOCS患病率筛查中接受了TVS。9078名妇女因接受子宫切除术而不符合条件，2271名妇女因未记录子宫内膜厚度而不符合条件；然而，其中157名妇女在TVS上显示子宫内膜异常，并被纳入分析。中位随访时间为5.11年（IQR 4.05-5.95）。136名患有子宫内膜癌或AEH的妇女在接受TVS治疗的一年内被纳入我们的主要分析。子宫内膜癌或AEH的最佳子宫内膜厚度临界值为5.15 mm，敏感性为80.5% (95% CI 72.7 ~ 86.8)，特异性为86.2%（85.8 ~ 86.6）。5 mm或更大临界值的敏感性和特异性分别为80.5%（72.7-86.8）和85.7% (85.4-86.2)；对于5 mm或更大的子宫内膜截距并伴有子宫内膜异常的女性，其敏感性和特异性分别为85.3%（78.2-90.8）和80.4%（80.0-80.8）。对于10 mm或更大的临界值，敏感性和特异性分别为54.1%（45.3-62.8）和97.2%（97.0-97.4）。当我们的分析仅限于96名患有子宫内膜癌或AEH的妇女，她们在诊断前的UKCTOCS扫描中没有绝经后出血症状，并且有子宫内膜厚度测量，5mm的截止值达到了77.1%（67.8-84.3）和85.8%（85.7-85.9）的敏感性和特异性。logistic回归模型确定25%的人群为高危人群，39.5%的子宫内膜癌或AEH病例在这一高危人群中被确定。在这一高危人群中，6.75 mm的临界值的敏感性为84.3%(71.4-93.0)，特异性为89.9%（89.3-90.5）。我们的研究结果表明TVS筛查子宫内膜癌对绝经后妇女具有良好的敏感性。诊断程序和假阳性结果的负担可以通过将筛查限制在高风险人群中来减轻。子宫内膜癌人群筛查的作用仍不确定，但我们的研究结果对绝经后妇女因阴道出血以外的原因进行盆腔扫描的子宫内膜厚度增加的管理具有直接价值。
Background The increase in the worldwide incidence of endometrial cancer relates to rising obesity, falling fertility, and the ageing of the population. Transvaginal ultrasound (TVS) is a possible screening test, but there have been no large-scale studies. We report the performance of TVS screening in a large cohort.Methods We did a nested case-control study of postmenopausal women who underwent TVS in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) following recruitment between April 17, 2001, and Sept 29, 2005. Endometrial thickness and endometrial abnormalities were recorded, and follow-up, through national registries and a postal questionnaire, documented the diagnosis of endometrial cancer. Our primary outcome measure was endometrial cancer and atypical endometrial hyperplasia (AEH). Performance characteristics of endometrial thickness and abnormalities for detection of endometrial cancer within 1 year of TVS were calculated. Epidemiological variables were used to develop a logistic regression model and assess a screening strategy for women at higher risk. Our study is registered with ClinicalTrials.gov, number NCT00058032, and with the International Standard Randomised Controlled Trial register, number ISRCTN22488978.Findings 48 230 women underwent TVS in the UKCTOCS prevalence screen. 9078 women were ineligible because they had undergone a hysterectomy and 2271 because their endometrial thickness had not been recorded; however, 157 of these women had an endometrial abnormality on TVS and were included in the analysis. Median follow-up was 5.11 years (IQR 4.05-5.95). 136 women with endometrial cancer or AEH within 1 year of TVS were included in our primary analysis. The optimum endometrial thickness cutoff for endometrial cancer or AEH was 5.15 mm, with sensitivity of 80.5% (95% CI 72.7-86.8) and specificity of 86.2% (85.8-86.6). Sensitivity and specificity at a 5 mm or greater cutoff were 80.5% (72.7-86.8) and 85.7% (85.4-86.2); for women with a 5 mm or greater cutoff plus endometrial abnormalities, the sensitivity and specificity were 85.3% (78.2-90.8) and 80.4% (80.0-80.8), respectively. For a cutoff of 10 mm or greater, sensitivity and specificity were 54.1% (45.3-62.8) and 97.2% (97.0-97.4). When our analysis was restricted to the 96 women with endometrial cancer or AEH who reported no symptoms of postmenopausal bleeding at the UKCTOCS scan before diagnosis and had an endometrial thickness measurement available, a cutoff of 5 mm achieved a sensitivity of 77.1% (67.8-84.3) and specificity of 85.8% (85.7-85.9). The logistic regression model identified 25% of the population as at high risk and 39.5% of endometrial cancer or AEH cases were identified within this high risk group. In this high-risk population, a cutoff at 6.75 mm achieved sensitivity of 84.3% (71.4-93.0) and specificity of 89.9% (89.3-90.5).Interpretation Our findings show that TVS screening for endometrial cancer has good sensitivity in postmenopausal women. The burden of diagnostic procedures and false-positive results can be reduced by limiting screening to a higher-risk group. The role of population screening for endometrial cancer remains uncertain, but our findings are of immediate value in the management of increased endometrial thickness in postmenopausal women undergoing pelvic scans for reasons other than vaginal bleeding.