Efficacy and Toxicity in Scheduled Intravesical Gemcitabine Versus Bacillus Calmette-Guérin for Bladder Cancer: A Systematic Review and Meta-Analysis.

Background/

Objectives

The present study aimed to compare the efficacy and safety of intravesical gemcitabine versus Bacillus Calmette-Guérin administered after transurethral resection of bladder tumor in patients with non-muscle-invasive bladder cancer.

Methods

A comprehensive literature search was conducted using PubMed, Embase, and the Cochrane Library databases up to September 2025. Studies were eligible for inclusion if they were comparative studies evaluating intravesical gemcitabine versus Bacillus Calmette-Guérin following transurethral resection of bladder tumor. The primary outcomes were recurrence-free survival, progression-free survival, and incidence of adverse events. Pooled hazard ratios were calculated using a random-effects model based on log hazard ratios and standard error values.

Results

Seven studies comprising approximately 774 patients were included in this analysis. The pooled hazard ratio was 0.80 (95% confidence interval, 0.42-1.53) for recurrence-free survival and 0.76 (95% confidence interval, 0.46-1.26) for progression-free survival, indicating no significant difference between gemcitabine and Bacillus Calmette-Guérin. However, gemcitabine was associated with a significantly lower incidence of adverse events, with a pooled odds ratio of approximately 0.48 (95% confidence interval, 0.27-0.86). Risk-of-bias assessment revealed that most randomized trials had "some concerns" based on the Risk of Bias 2 tool, whereas non-randomized studies were rated as having "moderate to serious" risk of bias according to the Risk of Bias in Non-randomized Studies of Interventions tool.

Conclusions

Gemcitabine demonstrated an oncologic efficacy comparable to that of Bacillus Calmette-Guérin in terms of recurrence and progression outcomes while showing a substantially lower incidence of treatment-related toxicities.