Introduction: Immunotherapy effectively treats advanced renal cell carcinoma in only a limited number of patients. However, the predicted prognosis for each patient in relation to immune status and response to immunotherapy remains problematic. We analyzed tumor-infiltrating lymphocyte (TIL) subsets to determine whether these correlated with the prognoses for the patients and the response to α-interferon therapy. Materials and Methods: TIL subsets from resected specimens of 79 patients were analyzed by two-color flow cytometry and then compared with the patients’ long-term clinical courses and responses to interferon therapy. Results: In patients with stages III and IV, an increased infiltration of CD4+ cells and decreased CD8+ cells constituted a fair prognostic factor. In 17 patients with metastatic lesions, 8 of 10 patients who had disease progression after interferon therapy showed an increase in CD8+ cells above 25%, whereas 2 responders and 5 patients who had stable disease showed infiltration of CD8+ cells below 25%. Conclusions: The TIL subset is a prognostic factor for advanced renal cell carcinoma, and its analysis provides a method to predict the susceptibility to interferon therapy.

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