The novel biomarker HE4 versus CA125 in detecting endometrial cancer: A case control prospective study.

Abstract

5094 Background: In endometrial cancer, there are no markers routinely used in clinical practice. This study prospectively investigates the sensitivity and specificity of new marker HE4 in detection of endometrial cancer. Methods: Serum samples were prospectively obtained 24 hours before surgery from 25 patients with endometrial cancer and from 25 patients with uterine benign pathology, operated from January 2011 to October 2011 at University Campus Bio-Medico of Rome. Preoperative CA125 levels were evaluated by a one-step “sandwich” radioimmunoassay. HE4 levels were determined using the HE4 enzymatic immune assay. The CA125 normal value is considered less than 35 U/mL. Two HE4 cut-off are considered: less than 70 pmol/L and less than 150 pmol/L. The specificity analysis was performed using the parametric T-Test for comparing the HE4 series and the Mann-Whitney test for the CA125 series. The level of statistical significance is set at p < 0.05. Results: The sensitivity of CA125 in detecting endometrial cancer is 16% whereas the sensitivity of HE4 is 48% and 28 % for 70 pmol/L and 150 pmol/L cut-off respectively. The specificity of HE4 is 100% (positive predictive value = 100%, negative predictive value = 65.79% and 58.14% considering the two HE4 cut-off, respectively), whereas the CA125 specificity is 72 % (positive predictive value = 36.36%, negative predictive value = 46.15%) in detection of endometrial cancer. Conclusions: HE4 has a good sensitivity and a specificity of 100% in detection of endometrial cancer and may be useful for detecting early stage endometrial cancer. In particular the HE4 at cut-off of 70 pmol/L yields the best sensitivity and specificity.