The efficacy and safety of intravesical gemcitabine vs Bacille Calmette-Guérin for adjuvant treatment of non-muscle invasive bladder cancer: a meta-analysis

Ziqi Ye1 Department of Pharmacy, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China, [email protected]

Jie Chen2 The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China

Yun Hong1 Department of Pharmacy, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China, [email protected]

Wenxiu Xin3 Laboratory of Clinical Pharmacy, Zhejiang Cancer Hospital, Hangzhou, People’s Republic of China

Si Yang1 Department of Pharmacy, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China, [email protected]

Yuefeng Rao1 Department of Pharmacy, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China, [email protected]Correspondence[email protected]

Abstract

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:

Supplementary materials

Figure S1 Flow chart for eligible studies.

Abbreviations: RCTs, randomized controlled trials; Gem, gemcitabine; BCG, Bacille Calmette-Guérin; BC, bladder cancer.

Figure S2 Sensitivity analysis of all clinical trials included.

Figure S3 Publication bias risk.

Abbreviations: RR, risk ratio; se, standard error of the mean.

Acknowledgments

This work was supported by the Natural Science Foundation of Zhejiang Province, China (Grant number LYY18H310002), Department of Health of Zhejiang Province, China (No 2015RCB006) and the Natural Science Foundation of Zhejiang Province, China (Grant number LY17H310002).

Disclosure

The authors report no conflicts of interest in this work.