PROSPECTIVE MULTICENTER STUDY ON CA-125 IN POSTMENOPAUSAL PELVIC MASSES

The purpose of this study was to determine the diagnostic value of CA 125 in comparison with transabdominal ultrasound (US) in the evaluatio n of postmenopausal women with pelvic mass to detect malignant epithel ial ovarian tumors. Postmenopausal patients with pelvic mass were stud ied with gynecologic examination, US and CA 125 determination. Three h undred eighty-eight patients were entered in the study. According to s tratification based on US (probably benign, equivocal, possibly malign ant) and CA 125 (<35 U/ml, negative; between 35 and 65 U/ml, borderlin e; >65 U/ml, positive), 290 patients were considered eligible for surg ery. Specificity, sensitivity, positive and negative predictive value, and accuracy of US and CA 125 were calculated with respect to histolo gical examination. Out of 290 operated patients, 134 had a benign ovar ian pathology, 34 had extraovarian benign pathology, 106 had an ovaria n malignancy, and 16 presented with an extraovarian malignant patholog y. The results according to ovarian malignant pathology were as follow s. CA 125 (>65 U/ml): Specificity, 92.5%; sensitivity, 71.7%; accuracy , 83.3%. CA 125 (>35 U/ml): Specificity, 82.0%; sensitivity, 78.3%; ac curacy, 80.4%. US: Specificity, 77.6%; sensitivity, 84.9%; accuracy, 8 0.3%. Combination of US and CA 125 (>65 U/ml): Specificity, 96.1%; sen sitivity, 91.7%; accuracy, 94.3%. Determination of CA 125 is a highly specific method in predicting ovarian cancer in postmenopausal women w ith a pelvic mass. The association with US significantly improves the overall accuracy and may support therapeutical decision making by dist inguishing between a significant percentage of women most likely to be nefit from prompt intervention and women who may be managed following minor surgical diagnostic approach, such as fine-needle aspiration. (C ) 1994 Academic Press, Inc.