Background: Intravesical therapy with Bacillus Calmette-Guerin (BCG)aims to reduce the incidence of tumour recurrence following transurethral resection (TUR) for patients with superficial bladder cancer. Objectives: The primary aim was to assess the efficacy of intravesically administered BCG following TUR in patients with Ta and Tl superficial bladder cancer compared to TUR alone. Efficacy is defined as tumourr recurrence, as measured by the number of patients developing recurrence at 12 months and the hazard ratio. The secondary objective was to evaluate and compare adverse events in the two treatment groups. Methods: Randomised or quasi-randomised trials of transurethral resection alone versus transurethral resection plus intravesical Bacillus Calmette-Guerin were identified. Four reviewers assessed trial quality and two abstracted the data independently. Results: Six randomized trials were included 585 eligible patients. There were significantly fewer patients with disease recurrence at 12 months in the BCG plus TUR group compared to those that received TUR alone (RR 0.30, 95%CI 0.21,0.43). Toxicities associated with BCG consisted mainly of cystitis (67%), haematuria (23%), fever (25%) and urinary frequency (71%). No BCG-induced deaths were reported. Conclusions: In patients with medium/high risk Ta or T1 bladder cancer, immunotherapy with intravesical BCG following TUR appears to provide a significant advan-... |