Low‐dose bacille Calmette‐Guerin (BCG) therapy in superficial high‐risk bladder cancer: a phase II study with the BCG strain Connaught Canada

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Abstract
To evaluate low-dose bacille Calmette-Guérin (BCG) therapy, with the Connaught Canada strain, in patients with superficial transitional cell carcinoma (STCC) of the urinary bladder. Between September 1990 and December 1992 25 patients were entered into a phase II study to evaluate the feasibility, response and toxicity of BCG immunotherapy for patients with high-risk STCC. Therapy consisted of six, weekly instillations of 27 mg (3 x 10(8) colony-forming units) of the BCG strain Connaught Canada. Maintenance therapy was administered monthly for 1 year with the same dosage. Of 25 eligible patients, 84% had complete responses after the initial cycle with low-dose BCG and had stable disease. Four patients had no response, three of whom subsequently underwent radical cystectomy. The mean length of follow-up was 30.8 months (25-36). Toxicity included profound local reactions such as severe dysuria, frequency and gross haematuria. No systemic infections, except fever, were seen; none of the patients needed isoniazid. All reactions were treated symptomatically. The results of this study suggest that low-dose BCG with the strain Connaught Canada can be successfully used in the treatment of patients with high-risk STCC. Toxicity was not reduced substantially by the lower dosage of BCG used.