Comparison of HE4, CA125, and Risk of Ovarian Malignancy Algorithm in the Prediction of Ovarian Cancer in Korean Women

Abstract

This study is a multi-center clinical study, which aimed to compare CA125, HE4, and risk of ovarian malignancy algorithm (ROMA) in predicting epithelial ovarian cancer of Korean women with a pelvic mass. Prospectively, serum from 90 Korean women with ovarian mass was obtained prior to surgery. For control group, serum from 79 normal populations without ovarian mass was also obtained. The HE4 and CA125 data were registered and evaluated separately and ROMA was calculated for each sample. Total 67 benign tumors and 23 ovarian cancers were evaluated. Median serum levels of HE4 and CA125, and ROMA score were significantly higher in patients with ovarian cancer than those with benign ovarian tumor and normal population (P < 0.001). In ROC curve analysis for women with a pelvic mass, area under the curve (AUC) for HE4 and ROMA was higher than CA125. Statistical differences in each study compared to CA125 were marginal (P compared to CA125; 0.082 for HE4 and 0.069 for ROMA). Sub-analysis revealed that AUC for HE4 and ROMA was higher than AUC for CA125 in post-menopausal women with a pelvic mass, but there were no statistically significant differences (P compared to CA125; 0.160 for HE4 and 0.127 for ROMA). Our data suggested that both HE4 and ROMA score showed better performance than CA125 for the detection of ovarian cancer in women with a pelvic mass. HE4 and ROMA can be a useful independent diagnostic marker for epithelial ovarian cancer in Korean women.

Keywords: CA125 Antigen; HE4; Ovarian Neoplasms; ROMA; Tumor Markers, Biological.

Fig. 1. ROC curves for ROMA algorithm, CA125, and HE4 in patients with pelvic masses. (A) ROC curves for overall patients. By comparing to AUC for CA125, AUC for HE4 (P = 0.082) and for ROMA (P = 0.069) were not inferior. (B) ROC curves for premenopausal patients. In premenopausal women, AUC for HE4 (P = 0.828) and for ROMA (P = 0.843) was not different from that for CA125. (C) ROC curves for postmenopausal patients. In postmenopausal women, AUC for HE4 (P = 0.160) and for ROMA (P = 0.127) was not different from that for CA125.

Fig. 2. ROC curves for ROMA algorithm, CA125, and HE4 in patients with normal population and ovarian cancer. (A) ROC curves for overall patients. AUC for CA125 showed marginal superiority to AUC for HE4 (P = 0.083) and for ROMA (P = 0.066). (B) ROC curves for premenopausal patients. In premenopausal women, AUC for HE4 (P = 0.640) and for ROMA (P = 0.610) was not different from that for CA125. (C) ROC curves for postmenopausal patients. In postmenopausal women, AUC for CA125 showed marginal superiority to AUC for HE4 (P = 0.091) and for ROMA (P = 0.087).