OVX1, macrophage-colony stimulating factor, and CA-125-II as tumor markersfor epithelial ovarian carcinoma - A critical appraisal

BACKGROUND. Ovarian carcinoma remains the leading cause of death from gynec ologic malignancy in Australia, the Netherlands, and the United States. CA- 125-II, the most widely used serum marker, has limited sensitivity and spec ificity for detecting small-volume, early-stage disease. Therefore, a panel of three serum tumor markers-OVX1, CA-125-II, and macrophage-colony stimul ating factor (M-CSF)-has been used to evaluate the sensitivity and specific ity of multiple markers for the detection of early-stage ovarian carcinoma. METHODS. Preoperative serum levels of OVX1, CA-125-II, and M-CSF were measu red in 281 patients with primary ovarian epithelial tumors of different his totypes. Among these tumors, 175 were malignant, 29 were of borderline mali gnancy, and 77 were benign. The three markers also were measured in sera fr om 117 apparently healthy women. Marker levels were considered abnormal at CA-125-II > 35 U/mL, OVX1 > 7.2 U/mL, and M-CSF > 3.5 ng/mL. RESULTS. Among 175 women with malignant ovarian tumors, at least one of the three serum markers was elevated in 85%, whereas CA-125-II was elevated in 80% (P = 0.008). In 58 patients with Stage I ovarian carcinoma, at least o ne of the three serum markers was elevated in 76%, whereas CA-125 levels we re elevated in 66% (P = 0.04). For patients with borderline and benign tumo rs, a combination of the three antigens had slightly higher sensitivity com pared with CA-125-II, but the differences were not statistically significan t. Among 117 apparently healthy women, CA-125-II was elevated in 4%, and on e of the three markers was positive in 17%. CONCLUSIONS. The sensitivity of a combination of three serum markers was si gnificantly greater than the sensitivity of the CA-125-II assay alone in pa tients with primary ovarian epithelial tumors of different histotypes. This was true for all stages, including early-stage, potentially curable diseas e. When used as single markers, however, only the CA-125-II assay could dis tinguish invasive Stage I tumors from apparently healthy women. Cancer 2001 ;92:2837-44. (C) 2001 American Cancer Society.