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In this paper, we summarize the results of a multicentric controlled study of induction treatment with intravesical BCG in patients with superficial bladder cancer (Ta, T1) or CIS. The BCG Tokyo 172 strain (Japan BCG K.K.) was given for 8 weeks, as a rule, in a dose of either 80 mg or 120 mg in 40 ml of saline instilled into the bladder. Sixty-six (90.5%) of the 73 patients registered in the study were evaluable for response. High response rates were obtained in the patients with Ta or T1 tumors, irrespective of the treatment dose; 65.4% CR, 27.3% PR and 7.3% NC for all. The number of CIS patients is too small to draw any conclusions, but 54.5% CR, 36.4% PR and 9.1% NC were obtained. Several factors were evaluated in relation to the tumor ablative effects. The CR rate was significantly higher for tumors less than 1 cm in size compared with tumors 1-3 or larger in size, although the response rates, including CR and PR, were very similar irrespective of the size. Other factors did not contribute to provoke a significant difference. Japanese elder people show a high positive rate of PPD reaction. Thus, in our study, 78% of the patients showed positive PPD reaction. In this situation, no significant relation between PPD reaction and BCG efficacy was obtained. In addition, OKT8, OKT7, OKT4, OKT4/OKT8 ratio, Leu7, ADCC activity and NK activity did not show any correlation with tumor ablative effect of BCG.(ABSTRACT TRUNCATED AT 250 WORDS)

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