Faculty of Medicine, University of Belgrade, Serbia.
Int J Gynecol Cancer. 2012 Feb;22(2):238-44. doi: 10.1097/IGC.0b013e318234f852.
In women with pelvic mass, cancer antigen 125 (CA125) had not achieved satisfactory sensitivity and specificity in the detection of ovarian cancer, particularly in patients with underlying endometriosis. The aim of this study was to determine the diagnostic potential of human epididymal protein 4 (HE4), the combination of HE4+CA125, and the Risk of Ovarian Malignancy Algorithm (ROMA) for patients with pelvic mass, particularly in differentiating endometriosis from carcinoma.
A prospective cross-sectional study was conducted at the Clinic for Gynecology and Obstetrics, Clinical Center of Serbia. Serum samples were obtained preoperatively from 108 women undergoing surgery for pelvic mass; 29 of them had ovarian carcinoma, and 79 had a nonmalignant ovarian disease (39 with benign tumor, 20 with endometriosis, 20 healthy controls). Sera were analyzed for the levels of HE4 and CA125 and were then compared with the final pathologic results. The diagnostic performance of HE4 and CA125 was estimated using receiver operating characteristic curve and area under the receiver operating characteristic curve.
The level of HE4 and CA125 was significantly higher among the patients with malignant tumors, compared with patients with nonmalignant disease. At the predefined specificity of 95%, HE4 and CA125 showed sensitivity of 65.5% and 58.6%, respectively, whereas the combination of HE4+CA125 reached 68.9% at the same specificity. Importantly, the level of HE4 did not differ significantly between the patients with endometriosis and with other nonmalignant diseases (which was not the case with CA125). Risk of Ovarian Malignancy Algorithm classified 96% of benign premenopausal cases as at low risk for ovarian cancer.
HE4 showed satisfactory capability of distinguishing endometriosis from ovarian cancer, which CA125 lacked. The Risk of Ovarian Malignancy Algorithm score proved to be useful in excluding malignant diagnosis in premenopausal women.
在患有盆腔肿块的女性中，肿瘤标志物 125（CA125）在检测卵巢癌方面的灵敏度和特异性均未达到满意的程度，尤其是在存在基础子宫内膜异位症的患者中。本研究的目的是确定人附睾蛋白 4（HE4）、HE4+CA125 联合检测以及卵巢恶性肿瘤风险算法（ROMA）对盆腔肿块患者，尤其是在区分子宫内膜异位症与癌方面的诊断潜力。
这是一项在塞尔维亚临床中心妇产科诊所进行的前瞻性横断面研究。对 108 例行手术治疗盆腔肿块的女性患者术前采集血清样本；其中 29 例为卵巢癌患者，79 例为非恶性卵巢疾病患者（39 例良性肿瘤、20 例子宫内膜异位症、20 例健康对照）。分析血清中 HE4 和 CA125 的水平，并与最终的病理结果进行比较。采用受试者工作特征曲线和曲线下面积评估 HE4 和 CA125 的诊断性能。
与非恶性疾病患者相比，恶性肿瘤患者的 HE4 和 CA125 水平显著升高。在预设的特异性为 95%时，HE4 和 CA125 的灵敏度分别为 65.5%和 58.6%，而 HE4+CA125 的组合在相同特异性时达到 68.9%。重要的是，HE4 水平在子宫内膜异位症患者与其他非恶性疾病患者之间无显著差异（而 CA125 则并非如此）。卵巢恶性肿瘤风险算法将 96%的良性绝经前病例归类为卵巢癌低风险。
HE4 具有良好的区分子宫内膜异位症与卵巢癌的能力，而 CA125 则缺乏这种能力。卵巢恶性肿瘤风险算法评分有助于排除绝经前女性的恶性诊断。
