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CA54/61 as a Marker for Epithelial Ovarian Cancer

Department of Obstetrics and Gynecology, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo 160 [S. N., D. A., M. Y., K. T., T. K.]; Department of Obstetrics and Gynecology, The Jikei University School of Medicine, 3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo 105 [E. K., Y. T.]; Department of Obstetrics and Gynecology, School of Medicine, Chiba University, 1-8-1 Inohana, Chiba-shi, Chiba 280 [N. I., H. T.]; Department of Obstetrics and Gynecology, Tokyo Medical College, 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo 160 [Y. N.]; Department of Internal Medicine, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104 [H. O.]; and Laboratories for Bioscience, Mochida Pharmaceutical Co., Ltd., 1-1-1 Kamiya, Kita-ku, Tokyo 115 [H. S., H. M.], Japan

Using a new one-step, double-determinant enzyme immunoassay, we performed quantitative measurements of a mucin-type glycoprotein antigen (CA54/61) that we recently detected in sera of ovarian carcinoma patients. When the cutoff value was set at 12 units/ml, at which a high diagnostic efficiency was demonstrated [or at 20 units/ml (mean + 3 SD of healthy females)], the positive rates of ovarian serous, mucinous, clear cell, and endometrioid carcinomas were 76% (or 63%), 63% (or 55%), 57% (or 52%), and 50% (or 38%), respectively. Even in mucinous cystadenocarcinoma, more than one-half of the cases were positive, indicating the potential utility of the assay in the diagnosis of mucinous tumors. In sera from patients with benign ovarian tumors, only 9% (or 4%) of the cases were positive, indicating the quite high specificity of this test for ovarian carcinomas. To make a comparison between CA54/61 and CA125, we set the cutoff level of CA125 at 110 units/ml, at which value a high diagnostic efficiency was demonstrated [or at 35 units/ml (mean + 3 SD of healthy females)]. When both CA54/61 and CA125 were assessed in sera from 36 patients with mucinous cystadenocarcinoma, the positive rates of CA54/61 and CA125 were 64% (or 56%) and 36% (or 56%), respectively, suggesting that CA54/61 is of clinical value as a new tumor marker for ovarian cancers, including mucinous tumors.

¹ To whom requests for reprints should be addressed.

Received 9/18/91. Accepted 12/17/91.