Abstract
The CA 15.3 serum assay, originally developed for the management of breast cancer patients has been evaluated in various groups of cancer patients for its applicability in clinical practice. This paper reviews the data from the literature addressing the issue of the usefulness of CA 15.3 in the management of cancer patients.
Two monoclonal antibodies, 115D8 and DF3, raised against cell surface constituents of breast carcinoma cells form the basis of this assay. Both antibodies react with a family of high molecular weight glycoproteins designated as Polymorphic Epithelial Mucins (PEMs). CA 15.3 is now available as a commercial immunoassay, employing 115D8 as catcher and DF3 as tracer antibody.
Measurements in sera from apparently healthy controls reveal that overall 1% of these healthy subjects exceed the cut-off level of 30 U/ml. Diagnostic sensitivity and specificity of the CA 15.3 assay in breast carcinoma patients is rather low since elevated levels are also observed in patients with benign breast and benign non-breast disease, as well as in patients with other malignancies. For monitoring patients undergoing therapy this assay proves to be of significant clinical value. After treatment increasing CA 15.3 levels are indicative of the presence of recurrent disease before this can be detected clinically.
The use of CA 15.3 in combination with CA 125 in ovarian carcinoma patients does increase the diagnostic accuracy of the CA 125 assay. Whether or not CA 15.3 alone or in combination with newly developed other PEM-based serum assays (as CA M26, CA M29 and MCA) is of value for the management of other groups of cancer patients is not yet clear.
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Bon, G.G., Kenemans, P., Yedema, C.A., van Kamp, G.J., Nijman, H.W., Hilgers, J. (1990). Clinical Relevance of the Tumor Marker CA 15.3 in the Management of Cancer Patients. In: Crommelin, D.J.A., Schellekens, H. (eds) From Clone to Clinic. Developments in Biotherapy, vol 1. Springer, Dordrecht. https://doi.org/10.1007/978-94-011-3780-5_14
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