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PURPOSE: The evaluation of lymphocyte subsets by using monoclonal antibodies in neoplastic patients has provided different results, partly in relation to the stage of the disease. Therefore, as a preliminary study of cancer patients treated with immunomodulating drugs, an analysis of lymphocyte subsets was performed in colorectal carcinoma patients. METHODS: In this study, a flow cytometric evaluation of lymphocyte subsets was performed in 33 patients affected by colorectal carcinoma, with or without metastases. RESULTS: A significant reduction of hemoglobin concentrations and hematocrit was observed in all of these subjects, associated with an evident increase of white blood cells, platelets, and HLA DR-positive T lymphocytes, whereas CD 3-CD 4-positive and CD 20-positive lymphocyte concentrations were decreased. Subjects without metastases showed an evident decrease of hemoglobin concentrations and an increase of white blood cells, platelets and CD 3-HLA DR-positive lymphocytes, while patients with disseminated disease also had reduced mean values of hematocrit, red blood cells, CD 3-CD 4-positive, and CD 20-positive lymphocytes. CONCLUSIONS: The main differences between colorectal carcinoma patients with or without metastases were represented by a decrease of red blood cells, CD 3-CD 4-positive, and CD 20-positive lymphocyte concentrations in the latter group.