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One hundred forty-two breast cancer patients were evaluated for three functional immunologic parameters: the ability of their lymphocytes to proliferate in response to general T-(phytohemagglutinin) and B-lymphocyte (pokeweed mitogen) stimulators and their ability to proliferate in response to specific autologous tumor antigens. Tests were performed on patient blood specimens collected approximately 2 hours prior to surgery or 2-4 weeks following chemotherapy. T-lymphocyte functional competence was impaired in 83/142 (58%) of the patients, while B-lymphocyte competence was impaired in 34/142 (24%) of these patients. A total of 21/52 (40%) of the patients had lymphocyte immunity against autologous tumor antigen. There were weak associations between the ability of patients' T- and B-lymphocytes to function normally, and their ability to respond to autologous tumor-antigen. There was no relationship of age, tumor burden (clinical or pathological tumor size), extension to skin and/or muscle, or metastasis to any of the three immunological parameters. A relationship (p = 0.0463) between T-lymphocyte competence and pathological nodal status was observed; individuals that were node positive for disease, tended to have impaired T-lymphocyte function. When evaluating T- and B-lymphocyte competence and lymphocytic immunity against tumor antigen in pre- and post-chemotherapy patients, an immunologic rebound (increase in immune parameters shortly after completion of chemotherapy) was observed in some patients. These results demonstrate the utility of measuring these immune parameters in breast cancer patients, their relevance to the natural biology of the disease, and the influence that chemotherapy may have on host immune function.

Cell-mediated immune (CMI) responses to tumor-associated antigens (TAA) in the early postoperative period were examined for correlations with disease recurrence and survival in a 13-year-prospective study of 77 stage 1 and 2 breast cancer patients treated with modified radical or radical mastectomy alone. Among the 21 patients who had positive lymphoproliferative tests using patients' peripheral blood mononuclear cells and autologous TAA of breast cancer cells, only one died from metastatic disease (5%). Among the 56 patients who had a negative test, 23 died from metastatic disease (41%). This difference is statistically significant (p = 0.002) Three other risk factors including tumor size, nodal status and cell differentiation patterns were also analyzed. When these three clinical-pathologic criteria were analyzed individually, none reliably predicted disease recurrence and survival. Nodal status was the most predictive clinical-pathologic risk factor, but was not significant (p = 0.089). The results of this study demonstrate the detection of CMI responses against autologous TAA by lymphoproliferative assays identifies a sub-set of stage 1 and 2 breast cancer patients who are at minimal risk of developing metastatic disease. This testing also identifies immunologically unreactive patients who are at risk for disease recurrence.