Adjuvant Gemcitabine, BCG for NMIBC Offer Similar Efficacy
Adjuvant intravesical gemcitabine and bacillus Calmette-Guérin for NMIBC do not differ significantly with respect to risk of recurrence, progression, and adverse events, new meta-analysis shows.
Intravesical gemcitabine may have similar efficacy and a lower incidence of dysuria and hematuria compared with bacillus Calmette-Guérin (BCG) for the adjuvant treatment of non-muscle invasive bladder cancer (NMIBC), according to a recent meta-analysis.
The meta-analysis, by Ziqi Ye, of the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China, and colleagues, included 5 pooled trials (including 3 randomized controlled trials [RCTs]) involving 386 patients with NMIBC. The investigators found no significant difference between the treatments with regard to risk of recurrence, progression, incidence of fever, or adverse events. Intravesical gemcitabine, however, was associated with a significant 69% lower overall relative risk of dysuria and 73% lower relative risk of hematuria compared with BCG, the investigators reported in OncoTargets and Therapy.
The authors acknowledged that their meta-analysis had a number of limitations, including the small number of clinical trials, the absence of double blinding in all 5 included studies, and the possibility of publication bias, which might introduce false-positive results in a meta-analysis.
The investigators noted that a systematic review published in 2012 indicated the gemcitabine had similar effects effects to BCG in patients with NMIBC, but its safety profile was not reported. The review included only 3 RCTs, and no meta-analysis was performed. In addition, results from studies comparing the efficacy and safety of intravesical gemcitabine and BCG in patients with NMIBC have yielded inconsistent conclusions.
Ye Z, Chen J, Hong Y, et al. The efficacy and safety of intravesical gemcitabine vs bacilli Calmette-Guérin for adjuvant treatment of non-muscle invasive bladder cancer: a meta-analysis. Onco Targets Ther. 2018;11:4641-4649.