The efficacy and safety of intravesical gemcitabine vs Bacille Calmette-Guérin for adjuvant treatment of non-muscle invasive bladder cancer: a meta-analysis
Received 8 April 2018
Accepted for publication 24 May 2018
Published 8 August 2018 Volume 2018:11 Pages 4641—4649
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Andrew Yee
Peer reviewer comments 2
Editor who approved publication: Dr Carlos E Vigil
Ziqi Ye,1,* Jie Chen,2,* Yun Hong,1 Wenxiu Xin,3 Si Yang,1 Yuefeng Rao1
1Department of Pharmacy, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China; 2The Second Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, People’s Republic of China; 3Laboratory of Clinical Pharmacy, Zhejiang Cancer Hospital, Hangzhou, People’s Republic of China
*These authors contributed equally to this work
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, Clinical Trials.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 English 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: intravesical therapy, non-muscle invasive bladder cancer, NMIBC, gemcitabine, Bacille Calmette-Guérin, meta-analysis
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