Differential diagnosis of ovarian cancer with tumour markers CA 125, CA 15-3 and TAG 72.3

Objective To determine the accuracy of tumour associated antigens CA 125, CA 15-3 and TAG 72.3 in the differential diagnosis of benign and malignant pelvic masses and to compare the results with a previously defined risk of malignancy index (RMI). Design Retrospective analysis of samples collected during a prospective observational study. Setting Department of Obstetrics and Gynaecology, the Royal London Hospital and Duke University Medical Center. Subjects One hundred and forty-three consecutive patients undergoing surgery for an adnexal mass. Method Tumour marker levels were determined by radio-immunoassay in stored serum samples obtained from 143 study subjects. Results The highest diagnostic accuracy of the tumour marker panel was achieved by defining a positive result as elevation of any two of CA 125 (> 30 u ml), CA 15-3 (> 30 u ml) and TAG 72.3 (> 10 u ml), (sensitivity 66.7%, specificity 93.1%). Similar diagnostic accuracy could be achieved by CA 125 alone using an upper limit of 50 u ml (sensitivity 66.7%, specificity 94.1%). Inclusion of CA 15-3 or TAG 72.3 in step-wise logistic regression analysis did not improve the discriminative performance of the RMI. Conclusion The risk of malignancy index incorporating CA 125, menopausal status and ultrasound is superior to the panel of three tumour markers for pre-operative differential diagnosis of the pelvic mass. © 1993.