Diagnostic accuracy of CA125 and HE4 in ovarian carcinoma patients and the effect of confounders on their serum levels.

OBJECTIVES: To evaluate the diagnostic accuracy of serum cancer antigen 125 (CA125) and human epididymis protein 4 (HE4) in the prediction of malignant ovarian masses then to analyze the effect of personal criteria and medical diseases on this accuracy.

STUDY DESIGN: This prospective study was performed in Zagazig University Hospital. The eligibility criteria for inclusion were; consecutive women, at any age ≥18 years, with established diagnosis of ovarian mass based on symptoms, signs, and imaging techniques. All patients underwent personal and medical history taking, preoperative serum CA125 and HE4 (cutoff 35 IU/mL and 150 pmol/L, respectively) assessment then postoperative histopathologic examination of lesions as a reference standard.

RESULTS: Among the included 140 patients, 62 were confirmed to have ovarian malignancy and 78 had benign lesions. Serum CA125 ≥35 IU/mL was associated with ovarian malignancy at sensitivity 91.9%, specificity 53.8%, and accuracy 70.7%. Raising its cutoff to 67.5 IU/mL decreased the sensitivity 83.9%, increased the specificity 80.7% with accuracy 82.1%. The combination of HE4 and CA125 showed sensitivity 75.8%, specificity 93.5%, and accuracy 85.7%. Women suffering from both diabetes mellitus and hypertension showed a significant decrease in CA125 concentration P = 0.02 with false negative results in (5/11) of them, making its sensitivity 54.5% in this condition.

CONCLUSIONS: The performance of CA125 in cancer ovary prediction can be improved by increasing its cutoff or by combining CA125 with HE4. Diabetes mellitus and hypertension can influence CA125 performance while HE4 is independent on these factors. This can be an additional value of the introduction of HE4 in cancer ovary prediction protocols.