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.
RCT Entities:
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.
Authors: Cyrill A Rentsch; Claire Biot; Joël R Gsponer; Alexander Bachmann; Matthew L Albert; Romulus Breban Journal: PLoS One Date: 2013-02-25 Impact factor: 3.240