Modification of cut-off values for HE4, CA125 and the ROMA algorithm for early-stage epithelial ovarian cancer detection: Results from 1021 cases in South China.
OBJECTIVE
The purpose of this study was to evaluate the performance of human epididymis protein 4 (HE4) and the Risk of Ovarian Malignancy Algorithm (ROMA) in early stage epithelial ovarian cancer (EOC) detection in patients in southern China. Additionally, this study proposes a possible ideal cut-off value for each marker to its own population in South China.


METHODS
Serum HE4 and CA125 were measured in 756 patients with pelvic masses (275 malignancies, 53 borderline tumors and 428 benign diseases), and their ROMA values were calculated. Areas under the receiver operator characteristic (ROC) curves (AUC) were assessed for HE4, CA125, ROMA and combinations of these biomarkers.


RESULTS
Both HE4 and ROMA performed better diagnostically than CA125 alone for early stage EOC, with AUCs ranging from 0.714 for HE4, 0.699 for ROMA, and 0.463 for CA125 in premenopausal subjects, and 0.902 for ROMA, 0.880 for HE4, and 0.256 for CA125 in postmenopausal subjects.


CONCLUSIONS
HE4 and ROMA alone were found to be better than CA125 for detecting borderline tumors and early-stage EOC. The optimal cut-off values (HE4: 70pmol/l for all; CA125: 60U/ml for pre- and 35U/ml for postmenopausal women) could notably improve diagnostic performance in EOC detection in patients in southern China.
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Ying
Y
Xu
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Rihui
R
Zhong
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Jian
J
He
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Rui
R
Ding
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Haixiong
H
Lin
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Yawen
Y
Deng
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Lijun
L
Zhou
Clinical Laboratory, Cancer Center of Sun Yat-Sen University, Guangzhou, 510060, People's Republic of China.
Xiaohui
X
Li
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Junyi
J
Jiang
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Yunwen
Y
Bao
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China.
Xiaohong
X
Luo
Clinical Laboratory, The Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China; Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, 510120, People's Republic of China. Electronic address: 1725012289@qq.com.
Chaohui
C
Duan
D000328:Adult; D000465:Algorithms; D018394:CA-125 Antigen / Q000097:blood*; D000077216:Carcinoma, Ovarian Epithelial; D016022:Case-Control Studies; D002681:China; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000175:diagnosis*; D010051:Ovarian Neoplasms / Q000175:diagnosis*; D011506:Proteins / Q000032:analysis*; D012680:Sensitivity and Specificity; D000081102:WAP Four-Disulfide Core Domain Protein 2
D018394:CA-125 Antigen; D011506:Proteins; D000081102:WAP Four-Disulfide Core Domain Protein 2; C569698:WFDC2 protein, human
CA125; Epithelial ovarian cancer; HE4; ROMA; South China