Abstract 855P
Background
Ovarian cancer (OC) is the most fatal gynaecological cancer, primarily due to late detection. Low sensitivity for early stage disease and false positive results are drawbacks to Cancer antigen 125 (CA125), the only OC biomarker currently in clinical practice. The aim of this study was to evaluate the performance of novel biomarkers Human Epididymis Protein 4 (HE4), the Risk of Ovarian Malignancy Algorithm, the Risk of Malignancy Index I and II, D-dimers, and fibrinogen, either alone or in combination, compared to CA125.
Methods
Pre-operative serum samples were collected from 296 patients undergoing primary debulking surgery for symptomatic pelvic tumours in an Irish quaternary hospital. To best reflect clinical practice, tumours found to be borderline or extra-ovarian on final histology were included. Recurrent OC and patients undergoing neoadjuvant chemotherapy were excluded. Sensitivity and specificity were calculated for each biomarker. Logistic regression models were fitted for each individual biomarker and for various biomarker combinations. A ROC comparison was then undertaken.
Results
The study consisted of 96 premenopausal and 200 postmenopausal women.There were 154 benign, 43 borderline, and 99 malignant cases, of which serous OC was the most common subtype (47%). In the premenopausal group, the combination of HE4 and fibrinogen had the highest ROC-AUC at 75.8% but no biomarker(s) reached statistical significance compared to CA125. In the postmenopausal group, two panels (CA125 + HE4 + D-dimer + fibrinogen, and HE4 + d-dimer + fibrinogen) were significantly different to CA125 on ROC analysis (both p = 0.029).
Conclusions
The addition of biomarker(s) to CA125 does not increase OC detection in premenopausal women. Where HE4 and fibrinogen may play a role here is as a second-step test, when TVUS results are inconclusive and CA125 is positive, to increase specificity. A novel biomarker panel including HE4, d-dimers and fibrinogen improved the diagnostic accuracy of CA125 alone in postmenopausal women and could aid in the preoperative triaging of pelvic masses. Prospective studies are needed to validate this panel and to assess the cost efficacy of adding multiple analytes to current decision making protocols.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.