Long-term intravenous administration of activated autologous lymphocytes for cancer patients does not induce antinuclear antibody and rheumatoid factor.

The treatment of activated autologous lymphocyte can lead to a potent antitumor effect with destruction of autologous cancer cells, but potential adverse autoimmune effects due to destruction of autologous tissue must also be considered. This study was performed to evaluate whether administration of activated autologous lymphocytes induces autoimmune disease. Patients with advanced cancer, who underwent transfer therapy with activated autologous lymphocytes, were eligible for the study. Informed consent was obtained from 22 patients with hepatocelluler carcinoma, ovarian cancer, gastric cancer, etc. The variation in activated lymphocyte phenotypes was CD3+/HLA-DR+ activated T lymphocytes, 23% to 99%; including CD4+ cells, 4% to 65%; CD8+ cells, 10 to 91%; and CD16+/ICD56+ NK cells, 1% to 59%. Of the 22 patients, levels of antinuclear antibody and/or rheumatoid factor were above normal limits during the study in the following 5 patients: 3 patients showed no marked changes, one patient a slight decrease in rheumatoid factor and one patient a slight increase in antinuclear antibody during the course of treatment, respectively. The values for these markers of the other 17 patients varied within normal limits during treatment. Mild transient fever occurred in several patients as an adverse event. There were no other adverse reactions. No clinical symptoms or signs suggestive of autoimmune disease occurred in any patient during or after treatment. These results suggested that long-term administration of activated autologous lymphocytes does not induce autoimmune disease.