Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology, University College London, London.
Medical Research Council Clinical Trials Unit at University College London, Institute of Clinical Trials and Methodology, University College London, London; Department of Women's Cancer, Institute for Women's Health, University College London, London.
Am J Obstet Gynecol. 2020 Jan;222(1):56.e1-56.e17. doi: 10.1016/j.ajog.2019.07.031. Epub 2019 Jul 24.
Transvaginal ultrasound and serum CA125 are routinely used for differential diagnosis of pelvic adnexal mass. Use of human epididymis 4 was approved in the United States in 2011. However, there is scarcity of studies evaluating the additional value of human epididymis 4.
The objective of the study was to evaluate the performance characteristics of transvaginal ultrasound, CA125, and human epididymis 4 for differential diagnosis of ovarian cancer in postmenopausal women with adnexal masses.
This was a cohort study nested within the screen arms of the multicenter randomized controlled trial, United Kingdom Collaborative Trial of Ovarian Cancer Screening, based in England, Wales, and Northern Ireland. In United Kingdom Collaborative Trial of Ovarian Cancer Screening, 48,230 women randomized to transvaginal ultrasound screening and 50,078 to multimodal screening (serum CA125 interpreted by Risk of Ovarian Cancer Algorithm with second line transvaginal ultrasound) underwent the first (prevalence) screen. Women with adnexal lesions and/or persistently elevated risk were clinically assessed and underwent surgery or follow-up for a median of 10.9 years. Banked samples taken within 6 months of transvaginal ultrasound from all clinically assessed women were assayed for human epididymis 4 and CA125. Area under the curve and sensitivity for diagnosing ovarian cancer of multiple penalized logistic regression models incorporating logCA125, log human epididymis 4, age, and simple ultrasound features of the adnexal mass were compared.
Of 1590 (158 multimodal, 1432 ultrasound) women with adnexal masses, 78 were diagnosed with ovarian cancer (48 invasive epithelial ovarian, 14 type I, 34 type II; 24 borderline epithelial; 6 nonepithelial) within 1 year of scan. The area under the curve (0.893 vs 0.896; P = .453) and sensitivity (74.4% vs 75.6% ;P = .564) at fixed specificity of 90% of the model incorporating age, ultrasound, and CA125 were similar to that also including human epididymis 4. Both models had high sensitivity for invasive epithelial ovarian (89.6%) and type II (>91%) cancers.
Our population cohort study suggests that human epididymis 4 adds little value to concurrent use of CA125 and transvaginal ultrasound in the differential diagnosis of adnexal masses in postmenopausal women.
经阴道超声和血清 CA125 常用于盆腔附件肿块的鉴别诊断。人附睾蛋白 4 于 2011 年在美国获得批准使用。然而，评估人附睾蛋白 4 附加价值的研究较少。
本研究旨在评估经阴道超声、CA125 和人附睾蛋白 4 对绝经后妇女附件肿块卵巢癌的鉴别诊断性能。
这是一项嵌套在英国协作卵巢癌筛查多中心随机对照试验筛查臂中的队列研究。在英国协作卵巢癌筛查试验中，48230 名接受经阴道超声筛查的女性和 50078 名接受多模态筛查（血清 CA125 由卵巢癌风险算法解读，二线经阴道超声）的女性进行了第一次（患病率）筛查。有附件病变和/或持续高风险的女性进行临床评估，并进行手术或中位随访 10.9 年。对所有接受临床评估的女性在经阴道超声检查后 6 个月内采集的储存样本进行人附睾蛋白 4 和 CA125 检测。比较多罚逻辑回归模型中纳入 logCA125、log 人附睾蛋白 4、年龄和附件肿块简单超声特征的曲线下面积和诊断卵巢癌的敏感性。
在 1590 名（158 名多模态，1432 名超声）有附件肿块的女性中，78 名在扫描后 1 年内被诊断为卵巢癌（48 名侵袭性上皮性卵巢癌、14 名 I 型、34 名 II 型、24 名交界性上皮性、6 名非上皮性）。在固定特异性为 90%的模型中，纳入年龄、超声和 CA125 的曲线下面积（0.893 与 0.896；P=0.453）和敏感性（74.4%与 75.6%；P=0.564）与同时纳入人附睾蛋白 4 的模型相似。两个模型对侵袭性上皮性卵巢癌（89.6%）和 II 型（>91%）癌症的敏感性均较高。
我们的人群队列研究表明，在绝经后妇女附件肿块的鉴别诊断中，人附睾蛋白 4 与 CA125 和经阴道超声联合使用时，附加价值有限。
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