Diagnostic performance of HE4 and ROMA among Chinese women

Abstract Objective Human epididymis protein 4 (HE4) has been suggested as a new biomarker for the detection of ovarian cancer. Because there are few reports on HE4 in terms of ovarian cancer diagnosis in the Chinese population, we evaluated the diagnostic performances of HE4 and the ROMA in Chinese women with pelvic masses. Methods The serum concentrations of CA 125 and HE4 in 318 Chinese women with pelvic masses (39 of which were ovarian cancers) were determined. Results For the discrimination of benign gynecological diseases from ovarian cancer, the sensitivity and specificity values were 87.2% and 75.8% for the ROMA and 51.3% and 97.3% for HE4. The ROMA also showed higher sensitivity than HE4 in both the early and advanced stages. In the ROC curve analysis, the AUC values for ROMA, HE4 and CA 125 were 0.927, 0.907 and 0.785, respectively. Conclusions As a new tumor marker, HE4 shows high specificity and efficacy in the Chinese population, while the ROMA that combines HE4 and CA 125 shows high sensitivity and a high Youden’s index. These markers should be extended to China since they have good diagnostic performances.