Report on international comparative evaluation of possible value of assays for immune complexes for diagnosis of human breast cancer.

There have been several reports on the possible value of measurement of circulating immune complexes for the diagnosis of human breast cancer. To begin to evaluate this possibility and the comparability of results among laboratories, a cooperative study was organized under the auspices of the International Agency for Research on Cancer and the National Cancer Institute (NCI) of the United States. Investigators from four laboratories performing assays for immune complexes were sent coded aliquots of serum specimens from the NCI-Mayo Clinic Serum Bank. The serum panel consisted of specimens from 30 patients with breast cancer (including 20 from untreated patients with resectable tumors), 30 preoperative patients with benign breast disease, and 30 normal women. Although some significant differences in levels of immune complexes between cancer patients and controls were seen, none of the assays had sufficient discriminatory capacity to support optimism about the diagnostic value of this approach. To relate the results with immune complexes to those with a widely used cancer marker, the same sera were also tested for levels of carcinoembryonic antigen (CEA). The CEA assay provided significant discrimination between cancer patients and normal donors but did not significantly discriminate between malignant and benign breast diseases.