Auqmetation of antitumor immunity by a mixture of OK-432 and fibrinogen

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OK-432 (5 KE), an antineoplastic agent prepared form an attenuated strain of Streptococcus pyogenes, was dissolved in 1 ml of aprotinin (1,000 KIE) and mixed with 80 mg of fibrinogen containing factor-XIII.A single intratumoral injection of the mixture was administered preoperatively under endoscopy in more than 100 patients with colorectal carcinoma. Postoperative histopathological examinations revealed the formation of fibrin mesh at the site of injection and marked infiltration of inflammatory cells into the tumor stroma on the day following injecton ; the formation of granulomas containing many giant cells after 4 to 7 days ; and extensive destruction of tumor tissue after 14 days. We analyzed the results of a new therapy for hepatocellular carcinoma (HCC) : transarterial immuno-embolization (TIE) with OK-432 and fibrinogen. Of 19 patients with advanced HCC in which other treatments were ineffective, 14 (74%) were surviving at 2 to 16 months after TIE.Serum levels of the tumor markers decreased in all patients and a marked reduction of tumor size was observed in 6 patients after TIE.High fever was observed in all patients. However, deterioration of liver function seemed to be negligible. Histological examination of resected specimens following TIE showed massive infiltration of mononuclear cells around tumor cell nests of the main tumor and intrahepatic metastases.