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A randomized controlled study was conducted to investigate the effects of PSK in the treatment of small cell carcinoma of the lung (SCC). A total of 109 cases were given standard chemotherapy consisting of 1mg Vincristine, 200-400mg Cyclophosphamide, and 2-4mg Mitomycin-C weekly for 4 to 8 weeks, with or without radiotherapy. To the group allocated to PSK, 3g/day of PSK was orally administered along with the above treatment. Of 93 eligible cases, 46 were PSK and 47 were control group. Response rates for PSK and control were 45%and 46%, respectively. The median duration of response for PSK (25w) was significantly longer than that for controls (13w), although survival rates for PSK and control groups were not significantly different. A tendency towards better survial in the PSK group was observed in cases responsive to chemo-and radiotherapy, with a higher pretreatment lymphocyte count and with good performance status (0-1). Changes of lymphocytes, PS score, erythrocyte sedimentation rates, A/G ratio etc were persistently beneficial for patients in the PSK group. The frequency and severity of side effects oriented to the standard chemotherapy and radiotherapywere not different between the both groups.It was concluded that immunotherapy with PSK would be beneficial in the treatment of SCC when used in cases responsive to basic treatment, particularly in the patients with good prognostic factors.

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Biological Study on Hot-Water Extract from Delipidated Mycobacterium bovis Strain BCG. Tohoku J. exp. Med., 1979, 129 (3), 285-293 -The biological activity of a hot-water extract from delipidated BCG, des ignated as HSA (Hot-water Soluble Adjuvant), was investigated. The HSA did not induce hyperreactivity to bacterial endotoxin. The hot-water extract from which nucleic acids had been removed by streptomycin (SM-HSA) was found to enhance the delayed-type hypersensitivity as evidenced by the results of footpad reaction of mice. The HSA and SM-HSA could be injected to mice by an intraperitoneal route for 20 consecutive days without undesirable side effects. A comparative study was made on the effects of HSA in relation to the duration and doses of treatment with HSA using the ddI mice inoculated with Sarcoma-180. The most remarkable effect was observed when 0.25 mg of HSA had been injected for 20 consecutive days. Also SM-HSA was found to exert antitumor activity when applied in the same manner as above. These results suggest that the presence of nucleic acids is not related to the biological and antitumor activities of the hotwater extract.hydro-soluble adjuvant; BCG; antitumor activity

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