Low-dose versus standard-dose bacille Calmette-Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials

• Published in: Investigative and clinical urology 2022, 63(2), , pp.140-150
• Main Authors: Choi, Se Young, Ha, Moon Soo, Kim, Jung Hoon, Chi, Byung Hoon, Kim, Jin Wook, Chang, In Ho, Kim, Tae-Hyoung, Myung, Soon Chul
• Format: Article
• Language: English
• Subjects: administration; adverse effects; BCG Vaccine - adverse effects; Female; Humans; intravesical; Male; Randomized Controlled Trials as Topic; recurrence; Special; urinary bladder neoplasms; Urinary Bladder Neoplasms - drug therapy; 비뇨기과학
• ISSN: 2466-0493; 2466-054X
• DOI: 10.4111/icu.20210340

Intravesical BCG (bacille Calmette-Guérin) instillation in patients with non-muscle-invasive bladder cancer decreases the risk for tumor recurrence and progression. After one BCG product was discontinued, a chronic global BCG shortage occurred. We focused on identifying a reduced dose of BCG that could maintain efficacy and reduce adverse effects. We conducted a comprehensive literature search of PubMed, Embase, the Cochrane Library, CINAHL, Web of Science, and Scopus to identify randomized controlled trials through April 2021. The odds ratios (ORs) and 95% confidence intervals (CIs) for the low and standard doses in nine studies were compared. A low dose was defined as a low volume of BCG compared with the standard BCG dose (Armand Frappier, 120 mg; Connaught, 81 mg; Danish 1331, 120 mg; modified Danish 1331, 120 mg; Tokyo 172, 80 mg). The low-dose group experienced aggravated recurrence (OR, 1.45; 95% CI, 1.09-1.94; p=0.01) but similar progression (OR, 1.11; 95% CI, 0.76-1.62; p=0.59), similar cancer-specific survival (OR, 1.02; 95% CI, 0.60-1.75; p=0.93), similar overall survival (OR, 1.09; 95% CI, 0.76-1.56; p=0.65), favorable adverse effects (OR, 0.41; 95% CI, 0.28-0.62; p