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Low‐dose bacille Calmette‐Guerin (BCG) therapy in superficial high‐risk bladder cancer: a phase II study with the BCG strain Connaught Canada
Author(s) -
Mack D.,
Frick J.
Publication year - 1995
Publication title -
british journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 0007-1331
DOI - 10.1111/j.1464-410x.1995.tb07308.x
Subject(s) - medicine , dysuria , toxicity , surgery , urology , gastroenterology , urinary system
Objective To evaluate low‐dose bacille Calmette‐Guerin (BCG) therapy, with the Connaught Canada strain, in patients with superficial transitional cell carcinoma (STCC) of the urinary bladder. Patients and methods Between September 1990 and December 1992 25 patients were entered into a phase II study to evaluate the feasibility, response and tox‐icity of BCG immunotherapy for patients with high‐risk STCC. Therapy consisted of six, weekly instillations of 27 mg (3 times 10 8 colony‐forming units) of the BCG strain Connaught Canada. Maintenance therapy was administered monthly for 1 year with the same dosage. Results 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 cystec‐tomy. The mean length of follow‐up was 30.8 months (25–36). Toxicity included profound local reactions such as severe dysuria, frequency and gross haema‐turia. No systemic infections, except fever, were seen; none of the patients needed isoniazid. All reactions were treated symptomatically. Conclusions 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.