CA 125 assay used in conjunction with CA 15-3 and TAG-72 assays for discrimination between malignant and non-malignant diseases of the ovary.

It has previously been suggested by the authors that elevated serum CA 125 levels may be of value in discriminating malignant from non-malignant pathologies among women with pelvic masses. Enhancement of this discrimination capacity might be achieved by utilizing additional serum assays. To test this hypothesis CA 125, CA 15-3 and TAG-72 levels were determined in double-blind fashion on 219 sera from patients undergoing diagnostic laparotomy for pelvic masses at six gynecological departments in the Stockholm area. Patient diagnoses were verified by chart review. Of the 219 patients, 27 (12%) had non-mucinous ovarian carcinoma, of whom 26 (96%) had CA 125 levels of 35 U/ml or greater 23 (85%) had levels in excess of 65 U/ml. Of 27 patients with mucinous or borderline ovarian carcinoma and patients with other malignancies 18 (67%) had CA 125 levels greater than 35 U/ml. Of 165 women with non-malignant diagnoses 26 (16%) had CA 125 levels in excess of 35 U/ml and 8 (5%) greater than 65 U/ml. Using reference values of 35 U/ml, 30 U/ml and 10 U/ml for the CA 125, CA 15-3 and TAG-72 assay respectively, only 3 of 165 (2%) of non-malignant patients were categorized as positive, compared to 23 of 27 (85%) of those with non-mucinous ovarian carcinoma. Moreover, an analysis of postmenopausal women revealed that the combination of assays--in a model controlling for the effect of CA 125--increased the specificity for diagnosis of benign diseases in women with pelvic masses.