CYTOKERATIN TUMOR-MARKER FOR OVARIAN-CANCER - TISSUE POLYPEPTIDE SPECIFIC ANTIGEN (TPS) AND M3 M21/

The aim of the present study was to evaluate the clinical usefulness o f the cytokeratin tumor marker M3/M21 as a screening, prognostic, and monitoring marker for ovarian cancer and as a predictive marker in pat ients with adnexal masses. In order to determine the specificity of th e M3/M21 test we investigated M3/M21 serum levels in several benign co nditions. The cytokeratin tumor markers M3/M21 and Tissue Polypeptide Specific Antigen (TPS) were also investigated in the followup of ovari an cancer patients. We evaluated M3/M21 serum levels in 75 patients su ffering from ovarian cancer FIGO stages Ia to III, using a prototype i mmunoradiometric assay (IRMA). Sera of patients with benign cysts, end ometriosis, pelvic inflammatory disease, inflammatory bowel disease an d liver cirrhosis were evaluated in 90, 10, 33, 10, and 20 cases, resp ectively. Furthermore, we analyzed TPS serum levels by means of IRMA d uring the follow-up of 40 patients suffering from ovarian cancer. With a sensitivity of 57% and a specificity of 95% M3/M21 was not suitable as a screening marker for ovarian cancer. Although M3/M21 was able to discriminate between ovarian cancer and benign adnexal tumors (univar iate logistic regression, p = 0.0003), M3/M21 did not provide addition al information (in addition to CA 125) (multivariate logistic regressi on, p = 0.2). M3/M21 serum levels were elevated in several benign cond itions such as liver cirrhosis and inflammatory bowel disease. In ovar ian cancer patients elevated M3/M21 serum levels prior to therapy were associated with a poor overall and disease-free survival (log-rank te st, p = 0.03, and log-rank test, p = 0.01, respectively). In patients with recurrent ovarian cancer M3/M21 and TPS showed median lead-time e ffects of 3.2 and 3.9 months, respectively. M3/M21, while obviously no t suitable far screening or differential diagnosis of adnexal masses, could be useful as an additional prognostic factor. M3/M21 and TPS are valuable tumor markers in the follow-up of ovarian cancer patients.