Department of Gynecology and Obstetrics, Faculty Hospital in Pilsen, Pilsen, Czech Republic.
Anticancer Res. 2012 Sep;32(9):4137-40.
The first aim of the project was to evaluate the benefits of the determination of human epididymis protein 4 (HE4) and the risk of ovarian malignancy algorithm (ROMA) index for primary detection of ovarian cancer in a population of Czech women. The second aim was to study the advantages HE4, cancer antigen 125 (CA125) and ROMA index for distinguishing between benign and malignant tumors. Aware of the age distribution of ovarian cancer, we focused on postmenopausal patients.
Our group of patients consisted of 256 females, 21 with ovarian cancer and 235 with benign ovarian tumors. All diagnoses were histologically verified. We determined the serum levels of HE4 and CA125 and calculated the ROMA2 index for postmenopausal women. Serum levels of the analytes were measured using an Architect 1000i instrument. Serum samples were collected prior to surgery or any other form of treatment and the results of the two groups of patients were compared (malignant vs. benign).
There was a significant difference in the serum levels for all parameters studied between the groups of patients with malignant and those with benign diagnoses (Wilcoxon test, p<0.0001). When all parameters were evaluated at 95% specificity, the HE4 cut-off was 112 pmol/l at a sensitivity of 71.42%, a positive predictive value (PPV) of 55.56%, a negative predictive value (NPV) of 97.14% and an area under the curve (AUC) of 0.9152. The CA125 cut-off was 81 IU/l at a sensitivity of 80.95%, a PPV of 58.62%, a NPV of 98.23% and an AUC of 0.9731. ROMA2 index had a cut-off 37.70% at a sensitivity of 85.71%, a PPV of 62.06%, a NPV of 98.65% and an AUC of 0.9803. The highest diagnostic efficiency was achieved by the ROMA2 index.
Determination of HE4 along with CA125 and ROMA2 index calculation is a suitable method for the improvement of the primary detection of ovarian cancer. This approach also improves the differential diagnostic possibilities for distinguishing between malignant and benign tumors.
该项目的首要目标是评估人附睾蛋白 4（HE4）的测定和卵巢恶性肿瘤算法（ROMA）指数在捷克女性人群中用于原发性卵巢癌检测的益处。第二个目标是研究 HE4、癌抗原 125（CA125）和 ROMA 指数在区分良性和恶性肿瘤方面的优势。考虑到卵巢癌的年龄分布，我们专注于绝经后患者。
我们的患者组由 256 名女性组成，其中 21 名患有卵巢癌，235 名患有良性卵巢肿瘤。所有诊断均经组织学验证。我们测定了绝经后妇女血清 HE4 和 CA125 的水平，并计算了 ROMA2 指数。使用 Architect 1000i 仪器测量分析物的血清水平。在手术或任何其他治疗之前采集血清样本，并比较两组患者的结果（恶性与良性）。
在恶性和良性诊断组患者中，所有研究参数的血清水平均存在显著差异（Wilcoxon 检验，p<0.0001）。当所有参数的特异性均为 95%时，HE4 截断值为 112pmol/l，敏感性为 71.42%，阳性预测值（PPV）为 55.56%，阴性预测值（NPV）为 97.14%，曲线下面积（AUC）为 0.9152。CA125 截断值为 81IU/l，敏感性为 80.95%，PPV 为 58.62%，NPV 为 98.23%，AUC 为 0.9731。ROMA2 指数的截断值为 37.70%，敏感性为 85.71%，PPV 为 62.06%，NPV 为 98.65%，AUC 为 0.9803。ROMA2 指数的诊断效率最高。
HE4 与 CA125 联合 ROMA2 指数计算是改善原发性卵巢癌检测的合适方法。这种方法还改善了区分良性和恶性肿瘤的鉴别诊断可能性。
