A Cochrane review [Abstract] 1 [withdrawn from publication] included 7 studies with a total of 1 901 subjects. The trials included included medium to high risk patients with Ta or T1 bladder cancer. Six trials had sufficient data for meta-analysis and included 1 527 patients, 693 in the mitomycin arm and 834 in the BCG arm. There was no significant difference for tumour recurrence between MMC and BCG (P = 0.76). A subgroup analysis of three trials that included only high risk Ta and T1 patients was in favour of BCG (P = 0.0008). Only two trials included sufficient data to analyse disease progression and survival, representing a total of 681 patients; 338 randomised to BCG and 343 to MMC. There was no significant difference between MMC and BCG for disease progression (log hazard ratio + variance: 0.044 + 0.04, P = 0.16) or survival (-0.112 + 0.03, P = 0.50). Local toxicities (dysuria, cystitis, frequency, and haematuria) were associated with both MMC (30%) and BCG (44%). Systemic toxicities, such as chills, fever and malaise, were observed with both MMC and BCG (12% and 19%, respectively) although skin rash was more common with MMC.
Comment: The quality of evidence is downgraded by inconsistency (heterogeneity in interventions and outcomes).
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