Local BCG-immunotherapy in bladder cancer patients. Immunological follow-up studies

In a controlled clinical study 10 patients with bladder cancer were treated with an additional local BCG-therapy. For this investigations only patients with tumour stage T1-2 NO MO were elected. The local BCG-therapy was done as intralesional BCG-injections, the interval between each management was 4 weeks over a period of 4 months to 1 year. Under this treatment in all 10 patients tumor regression in different forms was seen. In 5 patients the tumor was not more found, neither in clinical nor in histological examinations. Side effects of the therapy were: influenza-like syndrome (6 patients), mild temperature (6 patients), increase of liver transaminases (5 patients), and granulomas in lung and liver (2 patients). In the immunological follow-up studies we have seen an increase of the lymphocyte activity against tumor-associated antigen from bladder cancer tissue in the electrophoretic mobility test in 6 patients. The results in skin testing, using 5 recall-antigens and DNFB, showed an increase of reactivity in only 4 patients. The total number of lymphocytes increased over a longer period. We didn't find typical humoral changes. The results of our 10 patients show that an intralesional BCG-therapy could be successful in 5 patients. The effect of BCG for immunostimulation was seen in vitro in 6 patients and in vivo in 4 patients.