Development of BRM sensitivity test using the Th1/Th2 balance and clinical application

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In this study, we assessed the usefulness of Th1/Th2 balance of peripheral blood lymphocytes (PBLs) for therapeutic monitoring of cancer immunotherapy using OK-432. A Total of 56 curative gastric cancer patients (OK-432 administration group : 38 patients ; non-administration group : 18 patients) were used as subjects, and 3 KE of OK-432 was administered intradermally once every 2 weeks for OK-432 administration group. The production of IFN- γ and IL-2 of PBLs in the OK-432-administered group were significantly higher than that of OK-432-non administered group, while the production of IL-4 was not significantly different between them. The patients who had been administered OK-432 were divided into two groups (high-response and low-response) according to the NK activity at three months after surgery. In patients administered OK-432, the balance of Th1/Th2 was changed to Th1-dominant status. OK-432 high response patients showed a significant increase in the ratio of Th1/Th2, as compared to low response patients, and Th1-dominant immunological status was confirmed.These results suggest that the Th1/Th2 balance of PBLs is a useful indicator for monitoring of immunotherapy using OK-432 in patients with gastric cancer.