TY - JOUR
T1 - Effective dose and adverse effects of maintenance Bacillus Calmette-Gue'Rin in intermediate and high risk non-muscle invasive bladder cancer
T2 - a meta-analysis of randomized clinical trial
AU - Astram, Ari
AU - Khadijah, Adianti
AU - Yuri, Prahara
AU - Zulfan, Ahmad
AU - Mochtar, Chaidir Arif
AU - Danarto, R.
AU - Umbas, H. Rainy
AU - Hamid, Agus Rizal Ardy Hariandy
PY - 2014/10/1
Y1 - 2014/10/1
N2 - AIM: 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 significant differences between each dose in local side effect. However full dose regimen has higher systemic side effect compared to low and very low dose.
AB - AIM: 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 significant differences between each dose in local side effect. However full dose regimen has higher systemic side effect compared to low and very low dose.
UR - http://www.scopus.com/inward/record.url?scp=84942594149&partnerID=8YFLogxK
M3 - Article
C2 - 25633546
AN - SCOPUS:84942594149
SN - 0125-9326
VL - 46
SP - 298
EP - 307
JO - Acta medica Indonesiana
JF - Acta medica Indonesiana
IS - 4
ER -
