Clinical studies on streptococcal preparation (OK-432) combined with mitomycin-C, 5-FU and cytosine arabinoside in advanced cancer patients.

Streptococcal preparation (OK-432), a new type of anti-cancer agent, was given to the patients with advanced cancer in combination with Mitomycin-C, 5-FU and Cytosine arabinoside. OK-432 was administered intramuscularly with a daily dose of 2.0 KE consecutively or locally into the tumor with a large-dose of 100 KE. Most cases tolerated the long term administration of OK-432 without any severe side effects and the highest dose reached was 314 KE during 161 days of treatment. Of the 53 patients evaluated, 31 were given the initial large dose intratumoral OK-432. Thirteen were judged 0-C and Category 1 according to the Karnofsky criteria for a response rate of 44.8 per cent as compared with 12.5 per cent in the group without the initial large-dose administration.