The safety and efficacy of different doses of bacillus Calmette Guérin in superficial bladder transitional cell carcinoma.

Abstract:

OBJECTIVES:To conduct a trial using three different doses of bacillus Calmette-Guérin (BCG) to determine whether lowering the dose of BCG could reduce toxicity without compromising its efficacy in the treatment of superficial bladder cancer. METHODS:From July 2002 to June 2005, 152 patients with superficial bladder cancer entered the trial. The patients were randomized to receive three different doses of BCG: 40, 80, and 120 mg. There were no significant differences in clinical and pathologic characteristics among the three groups. Twenty-four patients could not be followed to the end of the study because of poor compliance. At completion of the study, 40 patients could be evaluated in group A (40 mg), 48 in group B (80 mg), and 40 in group C (120 mg). RESULTS:After treatment patients were evaluated for a mean follow-up period of 36 months (range 18 to 52 months). No significant difference in recurrence rate (20% versus 25% versus 20% respectively; P >0.05) was observed among the groups, and no progression of the disease was seen. Significant differences were observed among groups A, B, and C in local toxicity (30% versus 41.7% versus 70%, respectively; P <0.01). Systemic toxicity was more common in group C compared with groups B and A (P <0.01). CONCLUSIONS:Reduction in the dose of intravesical BCG can reduce the toxicity associated with the treatment of superficial bladder cancer without affecting the efficacy of therapy.

journal_name

Urology

journal_title

Urology

authors

Agrawal MS,Agrawal M,Bansal S,Agarwal M,Lavania P,Goyal J

doi

10.1016/j.urology.2007.07.017

subject

Has Abstract

pub_date

2007-12-01 00:00:00

pages

1075-8

issue

6

eissn

0090-4295

issn

1527-9995

pii

S0090-4295(07)01831-6

journal_volume

70

pub_type

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