Md. Shelley et al., A systematic review of intravesical bacillus Calmette-Guerin plus transurethral resection vs transurethral resection alone in Ta and T1 bladder cancer, BJU INT, 88(3), 2001, pp. 209-216
Objective To assess, in a systematic review, the effectiveness of intravesi
cal bacillus Calmette-Guerin (BCG) in preventing tumour recurrence in patie
nts with medium/high risk Ta and T1 bladder cancer.
Patients and methods An electronic database search of Medline, Embase, DARE
, the Cochrane Library, Cancerlit, Healthstar and BIDS was undertaken, plus
hand searching of the Proceedings of ASCO, for randomized controlled trial
s, in any language. comparing transurethral resection (TUR) alone with TUR
followed by intravesical BCG in patients with Ta and T1 bladder cancer.
Results The search identified 26 publications comparing TUR with TUR+BCG. S
ix trials were considered acceptable, representing 585 eligible patients, 2
81 in the TUR-alone group and 304 in the TUR+BCG group. The major clinical
outcome chosen was tumour recurrence. The weighted mean log hazard ratio fo
r the first recurrence, taken across all six trials, was -0.83 (95% confide
nce interval -0.57 to -1.08, P<0.001), which is equivalent to a 56%, reduct
ion in the hazard, attributable to BCG. The Peto odds ratio for patients re
curring at 12 months was 0.3 (95% confidence interval of 0.21-0.43, P<0.001
), significantly favouring BCG therapy. Manageable toxicities associated wi
th intravesical BCG were cystitis (67%), haematuria (23%), fever (25%) and
urinary frequency (71%). No BCG-induced deaths were reported.
Conclusion TUR with intravesical BCG provides a significantly better prophy
laxis of tumour recurrence in Ta and T1 bladder cancer than TUR alone. Rand
omized trials are still needed to address the issues of BCG strain, dose an
d schedule, and to better quantify the effect on progression to invasive di
sease.