BACKGROUND
The aim of this work was to analyze the diagnostic and prognostic value of serum human epididymis protein 4 (HE4) and Risk for Ovarian Malignancy Algorithm (ROMA) in epithelial ovarian cancer (EOC).
METHODS
Preoperative serum samples of 419 women (140 healthy controls, 131 ovarian benign cysts, 34 endometriosis, 114 EOC) were tested for CA125 and HE4 using fully automated methods (Abbott ARCHITECT) and validated cut-off values.
RESULTS
For the discrimination of benign masses from EOC, in pre-menopausal women the sensitivity and specificity were 92.3% and 59.4% for CA125, 84.6% and 94.2% for HE4, and 84.6% and 81.2% for ROMA while in post-menopausal women the sensitivity and specificity were 94.3% and 82.3% for CA125, 78.2% and 99.0% for HE4, 93.1% and 84.4% for ROMA.
In patients with EOC, elevated CA125, HE4 and ROMA levels were associated with advanced FIGO stage, sub-optimally debulking, ascites, positive cytology, lymph node involvement and advanced age (all p≤0.05). Elevated HE4 and ROMA (both p≤0.01), but not CA125 (p=0.0579), were associated with undifferentiated tumours. In multivariable analysis, elevated HE4 and ROMA (all p≤0.05) were independent prognostic factors for shorter overall survival, disease free survival and progression free survival.
CONCLUSIONS and IMPACT
This study underlines the high specificity of HE4 in discriminating endometriosis and ovarian benign cysts from EOC and the high sensitivity of CA125 in detecting EOC. We demonstrated HE4 and ROMA as independent prognostic factors. Multicenter studies are needed to draw firm conclusions about the applicability of HE4 and ROMA in clinical practice.
HE4 is more sensitive and specifi c than CA125in distinguishing endometrial cancer patients from women with normal endometrium, regardless of tumour stage and grade. sHE4 appears to be associated with a more aggressive tumour variant and it could be clinically useful, in identifying high-risk endometrial cancer patients, for a tailored surgical and postoperative therapy. HE4 significant correlation with decreased Overall Survival, Disease Free Survival and Progression Free Survival suggests its potential role as a novel prognostic marker for endometrial cancer.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.