The role of novel biomarker HE4 in endometrial cancer: a case control prospective study

Abstract

The aim of the study was to explore the clinical value of serum human epididymis secretory protein E4 (HE4) and CA125 in endometrial carcinoma. From January 2010 to April 2012, serum specimens were collected from consecutive cases of endometrial carcinoma and from cases of uterus benign disease (control group). The CA125 normal value is considered less than 35 U/mL. Two HE4 cutoff are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the Mann-Whitney test for the CA125 and HE4 series. The level of statistical significance is set at p < 0.05. The sensitivity of CA125 in detecting endometrial cancer is 19.8 %, whereas the sensitivity of HE4 is 59.4 and 35.6 % for 70 and 150 pmol/L cutoff, respectively. Thus the specificity of HE4 is 100 % (positive predictive value = 100 %, negative predictive value = 71.52 and 61.31 % considering the two HE4 cutoff, respectively), whereas the CA125 specificity is 62.14 % (positive predictive value = 33.9 %, negative predictive value = 44.14 %) in detection of endometrial cancer. Combining CA125 and HE4, the sensitivity to detect endometrial cancer is 60.4 and 34.6 %, at HE4 cutoff of 70 and 150 pmol/L, respectively, with a specificity of 100 %. HE4 may be a new tool for preoperative evaluation and postoperative surveillance of endometrial cancer patients, with a positive predictive value = 100 %. HE4 at cutoff of 70 pmol/L yields the best sensitivity and specificity.

The role of HE4 and CA125 in differentiation between malignant and non-malignant endometrial pathologies

“…HE4, along with CA125 and the menopausal status, is used to determine the risk of malignancy through an algorithm in patients with adnexal tumors [15]. Recent studies have shown that HE4 levels are elevated in patients with EC [11,16,17]. The role of tumor markers in detecting early stages of EC may be limited since postmenopausal bleeding is an early symptom of the disease [18].…”

Physiopathological factors affecting the diagnostic value of serum HE4-test for gynecologic malignancies

“…Two studies without a clear documentation of cutoff values reported the same specificity of 90%, while the sensitivities are 95% and 98%, respectively [21,22]. Other three studies using 50-70 pM cutoff values reported 78.8% sensitivity and 100% specificity [23][24][25].…”

Usefulness of Immuno-Magnetic Beads Conjugated with Anti-EpCAM Antibody for Detecting Endometrial Cancer Cells

“…Recently serum human epididymis protein 4 (HE4) has been used for the detection of endometrial cancer [23][24][25][26][27]. Angioli et al reported that the sensitivity and specificity of serum HE4 test were 59% and 100%, respectively [27]. Serum (plasma) protein analyses (containing HE4, CEA or CA125) were useful for detection of cancer relapse or therapeutic effect of chemotherapy.…”