Dewan Rupali, Dewan Abhinav, Hare Swati, Bhardwaj Mausumi, Mehrotra Krati
Professor, Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi, India.
Attending Consultant, Department of Radiation Oncology, Rajiv Gandhi Cancer Institute and Research Centre, Delhi, India.
J Clin Diagn Res. 2017 Jul;11(7):XC01-XC05. doi: 10.7860/JCDR/2017/28926.10285. Epub 2017 Jul 1.
Endometrial Cancer (EC) is a common female malignant disorder. To date, there are no specific tumour markers for EC that may be routinely used in clinical practice for diagnosis.
To evaluate the diagnostic performance of the serum Human Epididymis protein 4 (HE4) as biomarker for EC and to determine its association with clinicopathological variables.
The study population included 60 postmenopausal women with a diagnosis of EC and 60 healthy postmenopausal female subjects (control group). Concentrations of serum HE4 and CA-125 in EC patients and control group were determined using Enzyme-Linked Immunosorbent Assays (ELISA). The value of serum HE4 and CA-125 for the diagnosis and prediction of stage, histology, myometrial invasion and lymph nodal metastasis was analysed.
The mean serum HE4 and CA-125 levels were significantly higher in patients with EC than those with control group (p<0.05). Comparison for HE4 and CA-125 between different stages showed a statistically significant difference. Stage I EC patients with <50% myometrial invasion had a significantly lower mean serum HE4 value than patients with >50% myometrial invasion (p=0.007). Corresponding values of CA-125 showed a similar trend (p=0.023). There were significantly higher levels of HE4 and CA-125 in cases with lymph node involvement. The levels of serum HE4 and CA-125 were higher in the non-endometroid histology, but the difference was not statistically significant. The Receiver Operating Characteristics (ROC) curve analysis for EC and control group showed that HE4 had greater Area Under Curve (AUC) when compared with CA-125. Using ROC curve, a serum HE4 concentration of 69.8 pmol/l (AUC 0.974) and/or serum CA-125 level of 34.50 U/mL (AUC 0.714) was used to predict malignancy. Sensitivity of combined biomarkers showed no additional improvement in comparison to HE4 or CA-125 alone.
Our results show that HE4 is a sensitive diagnostic serum marker for detection of EC patients, exhibiting a better diagnostic performance compared to CA-125. Good performance of HE4 in diagnosis of early stages EC indicates its usefulness as a prognostic marker and also to monitor therapy and detect early recurrence.
子宫内膜癌（EC）是一种常见的女性恶性疾病。迄今为止，尚无可在临床实践中常规用于诊断的EC特异性肿瘤标志物。
评估血清人附睾蛋白4（HE4）作为EC生物标志物的诊断性能，并确定其与临床病理变量的关联。
研究人群包括60例诊断为EC的绝经后女性和60例健康绝经后女性受试者（对照组）。采用酶联免疫吸附测定（ELISA）法测定EC患者和对照组血清HE4和CA-125的浓度。分析血清HE4和CA-125对EC分期、组织学类型、肌层浸润和淋巴结转移的诊断及预测价值。
EC患者血清HE4和CA-125的平均水平显著高于对照组（p<0.05）。不同分期的HE4和CA-125比较显示差异有统计学意义。肌层浸润<50%的I期EC患者血清HE4平均水平显著低于肌层浸润>50%的患者（p=0.007）。CA-125的相应值显示出类似趋势（p=0.023）。有淋巴结转移的病例中HE4和CA-125水平显著更高。非子宫内膜样组织学类型的血清HE4和CA-125水平较高，但差异无统计学意义。EC患者和对照组的受试者工作特征（ROC）曲线分析表明，与CA-125相比，HE4的曲线下面积（AUC）更大。采用ROC曲线，血清HE4浓度为69.8 pmol/l（AUC 0.974）和/或血清CA-125水平为34.50 U/mL（AUC 0.714）用于预测恶性肿瘤。联合生物标志物的敏感性与单独使用HE4或CA-125相比无额外改善。
我们的结果表明，HE4是检测EC患者的一种敏感诊断血清标志物，与CA-125相比具有更好的诊断性能。HE4在早期EC诊断中的良好性能表明其作为预后标志物以及监测治疗和检测早期复发的有用性。
