Effective Dose and Adverse Effects of Maintenance Bacillus Calmette-Gue´Rin in Intermediate and High Risk Non-muscle Invasive Bladder Cancer: a Meta-analysis of Randomized Clinical Trial
ABSTRACT: to evaluate the
effective dose and adverse effects of BCG doses. Methods: we searched published
RCTs in Medline and Cochrane database before October 2013. Article using
maintenance BCG after TUR in intermediate-high risk non-muscle invasive bladder
cancer (NMIBC) and followed for effectiveness, local and systemic side effect
are included. Low risk patients, other dose and MIBC were excluded. Results:
meta-analysis of 6 clinical trials involving 2719 intermediate-high risk NMIBC
patients showed recurrence rate in full dose (81 mg), low dose (27 mg) and very
low dose (13.5 mg) were 33.3%, 34.7% and 30%, respectively. Meta-analysis of
2175 patients, 81 mg BCG was found to be superior to 27 mg in reducing tumour
recurrences (RR 0.86; 95% CI 0.77-0.96, I2 = 0% and p=0.008). Meta-analysis of
544 patients, the effectiveness reducing tumour recurrences in 27 mg BCG was
found to be superior to 13,5 BCG (RR 0.66; 95% CI 0.49-0.89, I2 = 8.8% and
p=0.006). Systemic side effects were happened in 25%, 28.5%, and 15.5% in the
doses 81.27 and 13.5 mg BCG, respectively. Low dose was superior to full dose
in affecting systemic side effect (p=0,000) but no difference in affecting
local side effect (p=0.137) in the meta-analysis of 1816 patients in 2 clinical
trials. Conclusion: full dose BCG had superior outcome to reduce recurrences
compared to low dose and very low dose. There were no signifcant differences
between each dose in local side effect. However full dose regimen has higher
systemic side effect compared to low and very low dose.
Key words: Bacillus
Calmette-Gue´Rin, dose and adverse effect, non-muscle invasive bladder cancer (NMIBC)
Author: Ari Astram dkk
Journal Code: jpkedokterangg140289
