The diagnostic accuracy of human epididymis protein 4 (HE4) for discriminating between benign and malignant pelvic masses: a systematic review and meta?analysis

Introduction Many women with benign pelvic masses, suspected of ovarian cancer, are unnecessarily referred for treatment at specialized centers. There is an unmet clinical need to improve diagnostic assessment in these patients. Our objective was obtain summary estimates the accuracy human epididymis protein (HE4) diagnosing cancer and compare performance HE4 that antigen 125 (CA125). Material methods We searched PubMed, Ovid Scopus using search terms “pelvic masses” “HE4”, identify studies evaluated malignant adult presenting a mass, diagnosis confirmed by histopathology. Screening, data extraction Risk Bias QUADAS-2 tool were done independently two authors. performed meta-analysis CA125 random-effects bivariate logit-normal model. A study protocol registered PROSPERO (CRD42020158073). Results In 17 eligible studies, which included 3404 patients, prevalence ranged from 15% 71%. Overall, heterogeneous. All seemed have recruited patients settings. seven resulted mean sensitivity 79.4% (95% confidence interval [CI] 74.1%–83.8%) specificity 84.1% CI 79.6%–87.8%), cut-off values 67–72 pmol/L. Based on eight 81.4% 74.6%–86.2%) 56.8% 47.9%–65.4%), 35 U/ml. Given 40% prevalence, positive predictive value (PPV) would be 76.9% (71.9%–81.2%) vs 55.6% (50.2%–60.9%) CA125. The negative (NPV) 85.9 (82.8%–88.6%) 81.9% (76.2%–86.4%), respectively. At NPV 95.8% 94.4%–96.7%) 94.4% 92.3%–96.0%) PPV 46.9% (40.4%–53.4%) 24.9% (21.1%–29.2%), Conclusions had higher similar compared high also HE4, but low it field benefit conducted general