Serum level of cryptic tumor antigens in breast cancer patients as determined by two monoclonal antibodies (M85/F36) and its comparison with CA 15-3.

Abstract

An enzyme immunoassay system that measures cryptic epitopes on breast cancer mucinlike antigens (BCM-EIA) was evaluated in a double-blind manner in sera from 58 normal blood donors, 36 sex- and age-matched controls, 36 patients with benign breast diseases, and 47 patients with breast cancer. Two murine monoclonal antibodies, M85 (IgM) as the solid-phase and F36/22 (IgG3) as the probe, were used in the configuration of the assay kit. The assay additionally utilized neuraminidase to remove terminal sialic acid from carbohydrate side-chains to expose cryptic epitopes that were masked in serum specimens. BCM-EIA monoclonal assay from the normal healthy blood donors resulted in 17.34 +/- 7.04 units/ml (mean +/- 1 S.D.) with an upper normal cutoff of 31.4 units/ml. The distributions of serum BCM in the sex- and age-matched controls (17.77 +/- 11.17) and benign breast diseases (14.34 +/- 11.46) were similar to that of normal blood donors. A mean value of 66.04 units/ml and 27.74 units/ml was obtained from breast cancer patients with active disease and without evidence of disease, respectively, a level much greater than those of normals, controls, and benign breast diseases. Simultaneous analysis of CA 15-3, a putative breast tumor marker, in the normal donors and breast cancer patients revealed correlation regression of (CA 15-3) = 0.876 (BCM) + 1.972, r = 0.856; and (CA 15-3) = 0.66 (BCM) + 16.094, r = 0.730, respectively. These data showed that there is a statistically significant correlation of CA 15-3 and BCM in normal blood donors' specimens.(ABSTRACT TRUNCATED AT 250 WORDS)