PROSPECTIVE MULTICENTER STUDY ON THE CLINICAL UTILITY OF CA-72.4 IN POSTMENOPAUSAL PATIENTS WITH PELVIC MASS

The study objective was to evaluate the sensitivity and specificity as well as the positive predictive value and negative predictive value o f CA 72.4 and CA 125 determination, separately and in combination, for diagnosing ovarian tumors in post-menopausal women with pelvic mass. The 299 patients recruited in this study underwent gynecological exami nation, plasma determination of CA 72.4 and CA 125, and laparotomy wit h histological definition of pelvic mass. CA 72.4 assay values were un der 3.9 U/ml in 194 cases (70.8%); values ranged from 3.9 to 4.5 U/ml in 7 cases (2.5%) and were greater than 4.5 U/ml in 73 cases (26.6%). CA 72.4 assay was positive (>4.5 U/ml) in 56 cases (57.1%) of malignan t ovarian pathology, in 4 cases (25%) of malignant extra-ovarian patho logy as well as in 9 cases (7.1%) of benign ovarian pathology and in 4 cases (11.8%) of benign extra-ovarian pathology. With a cut-off at 3. 9 U/ml, CA 72.4 showed a specificity of 91.3% and a sensitivity of 62. 2%, whereas with a cut-off at 4.5 U/ml specificity was 92.9% and sensi tivity 57.1%. Results of CA 125 assay for diagnosing a pelvic neoplasi a (ovarian or extra-ovarian), showed a specificity of 85.3% and sensit ivity of 68.8%. The agreement of the two markers (CA 125 and CA 72.4) as negative or positive shows a specificity of 77% and a sensitivity o f 84.7% for ovarian cancer and a specificity of 73.5% and sensitivity of 75% for the diagnosis of pelvic neoplasias.