Obstet Gynecol Sci.  2013 Jul;56(4):234-241.

Clinical efficacy of serum human epididymis protein 4 as a diagnostic biomarker of ovarian cancer: A pilot study

• Chung SH
• Lee SY
• Ju W
• Kim SC

Abstract

OBJECTIVE
To compare accuracy of serum human epididymis protein 4 (HE4) levels with cancer antigen 125 (CA-125) levels as biomarkers for ovarian cancer.
METHODS
The study population included 94 Korean women, including 32 patients with a diagnosis of ovarian cancer and 62 patients with a diagnosis of benign ovarian tumor. All diagnoses were confirmed by histopathological analysis. Serum HE4 levels were assessed using an HE4 enzyme immunoassay, which were performed according to the manufacturer's instructions. Serum CA-125 levels were determined using a Modular analytics E170 module.
RESULTS
The median serum CA-125 and HE4 levels were significantly higher in patients with ovarian cancer than those with other benign tumors (CA-125, 394.1 U/mL vs. 22.7 U/mL; HE4, 56.7 pM vs. 18.5 pM; P < 0.05 in both). An additional comparison revealed that the patients with endometriosis had greater median serum CA-125 levels than those with other benign ovarian tumors (32.0 U/mL vs. 17.9 U/mL, P = 0.03). Conversely, the median serum HE4 levels were similar among the two benign ovarian tumor groups, with no statistically significant difference observed (19.0 pM vs. 18.2 pM, P = 0.49). The receiver operating characteristics curve analysis for the benign ovarian tumor and ovarian cancer patients showed that HE4 showed a greater area under the curve with borderline significance when compared with CA-125 in both groups (0.93 vs. 0.85).
CONCLUSION
Serum HE4 levels may not only allow for the detection of ovarian cancer, but also allow for better differentiation of cases of ovarian cancer versus other benign ovarian tumors compared with serum CA-125.

Keyword

Biochemical tumor markers; CA-125; HE4 protein; Koreans; Ovarian cancer

MeSH Terms

Asian Continental Ancestry Group
Biomarkers
Endometriosis
Epididymis
Female
Humans
Immunoenzyme Techniques
Male
Ovarian Neoplasms
Pilot Projects
ROC Curve
Biomarkers, Tumor

Figure

• 

  Fig. 1 Comparison of (A) the serum CA-125 and (B) human epididymis-specific protein E4 (HE4) levels between ovarian cancer and benign ovarian tumor.

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  Fig. 2 Comparison of the area under the curve from the receiver operating characteristics (ROC) curve analysis for serum CA-125 and human epididymis-specific protein E4 (HE4) levels.

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