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经阴道超声筛查绝经后妇女子宫内膜癌的敏感性:英国 CTOCS 队列中的病例对照研究。

Sensitivity of transvaginal ultrasound screening for endometrial cancer in postmenopausal women: a case-control study within the UKCTOCS cohort.

机构信息

Gynaecological Oncology, UCL EGA Institute for Women's Health, London, UK.

出版信息

Lancet Oncol. 2011 Jan;12(1):38-48. doi: 10.1016/S1470-2045(10)70268-0. Epub 2010 Dec 10.

Abstract

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.

摘要

背景

全球范围内子宫内膜癌发病率的上升与肥胖、生育率下降和人口老龄化有关。经阴道超声(TVS)可能是一种筛查试验,但目前还没有大规模的研究。我们报告了在一个大队列中 TVS 筛查的表现。

方法

我们在英国卵巢癌筛查协作试验(UKCTOCS)中进行了一项基于绝经后妇女的巢式病例对照研究,该试验在 2001 年 4 月 17 日至 2005 年 9 月 29 日期间进行了招募。记录了子宫内膜厚度和子宫内膜异常,并通过国家登记处和邮寄问卷进行随访,记录了子宫内膜癌的诊断。我们的主要观察指标是子宫内膜癌和非典型子宫内膜增生(AEH)。计算了 TVS 后 1 年内检测子宫内膜癌的子宫内膜厚度和异常的性能特征。使用流行病学变量建立逻辑回归模型,并评估高危妇女的筛查策略。我们的研究在 ClinicalTrials.gov 上注册,编号为 NCT00058032,并在国际标准随机对照试验注册中心注册,编号为 ISRCTN22488978。

结果

在 UKCTOCS 患病率筛查中,48230 名妇女接受了 TVS。9078 名妇女因已行子宫切除术而不合格,2271 名妇女因子宫内膜厚度未记录而不合格;然而,其中 157 名妇女在 TVS 上有子宫内膜异常,被纳入分析。中位随访时间为 5.11 年(IQR 4.05-5.95)。在 TVS 后 1 年内有 136 名妇女患有子宫内膜癌或 AEH,包括在我们的主要分析中。检测子宫内膜癌或 AEH 的最佳子宫内膜厚度截断值为 5.15 mm,其敏感性为 80.5%(95%CI 72.7-86.8),特异性为 86.2%(85.8-86.6)。5 mm 或更大的截断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 或更大的截断值加上子宫内膜异常的妇女,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 或更大的截断值,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 名在诊断前 UKCTOCS 扫描时没有绝经后出血症状且子宫内膜厚度测量值可用的患有子宫内膜癌或 AEH 的妇女时,5 mm 的截断值达到了 77.1%(67.8-84.3)的敏感性和 85.8%(85.7-85.9)的特异性。逻辑回归模型确定了 25%的人群为高危人群,39.5%的子宫内膜癌或 AEH 病例在该高危人群中被发现。在这个高危人群中,6.75 mm 的截断值达到了 84.3%(71.4-93.0)的敏感性和 89.9%(89.3-90.5)的特异性。

解释

我们的研究结果表明,TVS 筛查对绝经后妇女的子宫内膜癌具有良好的敏感性。通过将筛查限制在高危人群中,可以减少诊断程序和假阳性结果的负担。子宫内膜癌的人群筛查的作用仍不确定,但我们的研究结果对因非阴道出血而进行盆腔扫描的绝经后妇女的子宫内膜增厚的管理具有直接价值。

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