Objective: Several studies have compared the safety and efficacy of intravesical gemcitabine (Gem) with Bacille Calmette-Guérin (BCG) for non-muscle invasive bladder cancer. However, the results are not consistent. We carried out a meta-analysis to provide a more comprehensive analysis of the efficacy and safety of these 2 drugs.
Methods: We searched PubMed, EMBASE, Cochrane Library, ClinicalTrials.gov, and reference lists. Randomized controlled trials and retrospective controlled trials comparing intravesical Gem and BCG in adjuvant therapy for non-muscle invasive bladder cancer published in Eng-lish were included in this study. The strength of association was weighed by pooled risk ratio (RR) with 95% CIs. Sensitivity analysis was performed to examine whether the findings of the meta-analysis were robust.
Results: We analyzed 386 subjects from 5 pooled trials. Compared with BCG, intravesical Gem had lower incidence of dysuria (overall RR =0.31, 95% CI: 0.16, 0.61, I2=0%, p=0.001) and hematuria (overall RR =0.27, 95% CI: 0.11, 0.71, I2=0%, p=0.008). There were no statistical differences in risk of recurrence, progression, incidence of fever, and any adverse events between intravesical Gem and BCG therapy (p>0.05). No publication bias was found.
Conclusion: This meta-analysis suggests that intravesical Gem may have similar efficacy and lower incidence of dysuria and hematuria compared with BCG. Nevertheless, we recommend additional high-quality randomized controlled trials to confirm these results.
Keywords: Bacille Calmette-Guérin; NMIBC; gemcitabine; intravesical therapy; meta-analysis; non-muscle invasive bladder cancer.