ADJUVANT IMMUNOTHERAPY WITH INTRAPLEURAL STREPTOCOCCUS-PYOGENES (OK-432) IN LUNG-CANCER PATIENTS AFTER RESECTION

A prospective randomized study to evaluate the effect of adjuvant intr apleural OK-432 immunotherapy after resection of lung tumor was conduc ted in 93 patients with primary lung cancer. Among them, 46 patients h ad had intrapleural OK-332 injection, 47 had not. In the meantime, ser ial measurements of serum immunosuppressive acidic protein, of serum i nterleukin-2 receptor and of the subpopulation of the peripheral blood cells and lymphocytes were performed in all these patients. Patient c haracteristics in these two groups (sex, age, histological type, patho logical stage, type of operation, and performance status) were compati ble. The results showed that adjuvant intrapleural OK-432 injection af ter resection had no beneficial effect on a patient's survival time. P atients who received intrapleural OK-432, had an increase in blood leu kocytes, granulocytes and monocytes and serum immunosuppressive acidic protein level. But the cell numbers of total T cells, suppressor/cyto xic cells, helper/inducer cells and natural killer cells of peripheral blood were decreased in the OK-432 positive group. Over half of the p atients had transient 1- or 2-day febrile reactions after intrapleural OK-432 injection. It was concluded that neither clinical observation nor immunological monitoring of peripheral blood could demonstrate a b eneficial effect from intrapleural OK-432 immunotherapy after complete resection of the tumor.