The diagnostic value of serum HE4 and CA-125 and ROMA index in ovarian cancer

open access
 May 19, 2016

Abstract

Ovarian cancer is a common malignancy of the female reproductive system. Tumor markers serve as tools in the diagnosis of the disease. The aim of the present study was to determine the diagnostic value of sera levels of carbohydrate antigen-125 (CA-125), human epididymis protein 4 (HE4) as well as the area under the curve of the receiver operating characteristic (ROC) and the risk of ovarian malignancy algorithm (ROMA) index in ovarian cancer. The sera were measured using an electrochemiluminescence immunoassay on 158 individuals (64 patients with ovarian cancer, 64 with ovarian benign tumor and 30 healthy individuals) between September 2013 and May 2015. The results showed that levels of HE4 and CA‑125 in the sera of the ovarian benign tumor group as well as their ROMA index were significantly higher (P<0.05) than those of the ovarian benign tumor and control groups, regardless of pre‑ or postmenopausal status. However, the level of CA‑125 was significantly higher (P<0.05) in the ovarian benign tumor group compared with the healthy group, while the level of HE4 was similar in the two groups. The sensitivity of the ROMA index was higher (P<0.01) with detection of HE4 and CA‑125. In the ovarian cancer group, the areas under ROC curves of ROMA, HE4 and CA‑125 were 0.994, 0.990 and 0.941, respectively. The specificity and positive predictive value of HE4 in the premenopausal ovarian cancer group reached 98.36 and 95%, respectively. In conclusion, the results showed that the serum level of HE4 and the ROMA index are important indicators in the diagnosis of ovarian cancer. However, in addition to HE4 and CA‑125 detection, the ROMA index is extremely valuable in improving the diagnostic efficiency of ovarian cancer.

Introduction

Ovarian cancer is one of the three most common malignant tumors in the female reproductive system. It has an insidious onset with a difficult early diagnosis (1). In approximately, 70% of all cases of ovarian cancer, the disease is not diagnosed before reaching an advanced stage (2). The 5-year survival rate associated with ovarian cancer is <30% (3). Over 90% of all cases of ovarian masses detected in premenopausal and ≤60% in postmenopausal women, are benign (4). The early diagnosis of ovarian malignant tumor becomes a key factor in improving the survival rate of patients. Tools currently in use for differentiating between low- and high-risk patients with ovarian cancer are the tumor markers carbohydrate antigen-125 (CA-125) and the human epididymis protein 4 (HE4), as well as the index value of risk of ovarian malignancy algorithm (ROMA) (5).
The tumor marker CA-l25 has been used for 30 years for the monitoring of ovarian cancer, diagnosis, effective evaluation, and recurrence (6). Although clinical application of CA-125 has been extensive, its specificity as a marker of malignant tumor or early diagnosis of ovarian cancer requires reassesment (7). In premenopausal women, the detection of CA-125 in ovarian cancer sensitivity and specificity is not ideal because of the menstrual cycle, pregnancy and other effects (8).
The introduction of HE4, a type of gynecological tumor marker, has attracted much attention. HE4 has shown a sensitivity and specificity of 72.9 and 95%, respectively, for differentiating between types of ovarian masses, which is better than that of CA-125 detection (9)......