Wednesday 21 September 2011
OC21.03: Ultrasound imaging compared to a multivariate predictive algorithm combining HE4 and CA 125 (ROMA®) in the pre-operative assessment of adnexal masses
To compare the pre-surgical ability of a multivariate predictive algorithm combining CA 125, HE4 and menopausal status (ROMA®) vs. ultrasound (US) imaging performed by an experienced examiner, for estimation of the risk of malignancy in patients with adnexal masses.
Prospective multi-center, double blind, clinical trial enrolling patients presenting with adnexal masses and candidate for surgical treatment. Blood samples for HE4 and CA 125 measurements and US were performed within 30 days prior to surgery. Masses were classified by US examiner according to IOTA criteria as: certainly or probably benign, difficult to classify, probably or certainly malignant. A separate self impression of presumed histological diagnosis was given. Separate logistic regression algorithms for pre- and post-menopausal women were utilized to categorize patients into low and high risk group for ovarian cancer (ROMA®). Outcome measures were sensitivity (Sens), specificity (Spec), ROC-AUC of ROMA®, CA 125, HE4 and US in discriminating adnexal masses.
173 patients entered in the study. At final pathology there were 80 (46.2%) malignancies, 18 (10.4%) borderline tumors and 75 (43.4%) benign diseases, all tumors were epithelial hystotype. Using a cut off for ROMA of 7.4% for pre-menopausal patients, and a cut off of 25.3% form post-menopausal patients The different test performed as follow: US (Sens 96.7%, Spec 87.5%, ROC-AUC = 0.95 95%CI: 0.91, 0.98), ROMA® (SENS 82.7%, Spec 83.8%, ROC-AUC = 0.89 95%CI: 0.84, 0.94), HE4 (Sens 74.5%, Spec 92.0%, ROC-AUC = 0.87 95%CI: 0.82, 0.93) CA 125 (Sens 90.8%, Spec 66.7%, ROC-AUC = 0.89 95%CI: 0.84, 0.94).
US expertise opinion remains superior in discriminating malignant masses compared to ROMA® algorithm, HE4 and CA125 alone. However, combination of biomarkers could offer an aid to less experienced sonographers in the preoperative triage of adnexal masses, by addressing malignancies to centers of excellence for the most appropriate surgical care.