Comparison of sequential intravesical gemcitabine and docetaxel versus bacillus Calmette-Guérin in the treatment of non-muscle invasive bladder cancer: A meta-analysis.

Abstract

e16603 Background: Bacillus Calmette-Guérin (BCG) is considered the standard treatment for non-muscle invasive bladder cancer (NMIBC). However, the global shortage of BCG, along with issues of unresponsiveness and recurrence after treatment, prompts the need for alternative therapies. Sequential intravesical gemcitabine and docetaxel (Gem-doce) has emerged as a promising second-line treatment option, warranting further investigation into its comparative efficacy in NMIBC management. Methods: We conducted a comprehensive search of PubMed, Embase, Cochrane, Scopus, and ClinicalTrials.gov using relevant keywords from inception until December 2024 to identify studies that directly compared Gem-doce and BCG in patients with NMIBC. Outcomes were stratified as high-grade recurrence-free survival (HG-RFS), recurrence-free survival (RFS), progression-free survival (PFS), cystectomy-free survival (CFS), cancer-specific survival (CSS), and overall survival (OS) at 6-, 12-, 24-, and 36-month time points. Statistical analysis was performed with Review Manager 5.4.1. Risk ratios (RR) with 95% confidence intervals (CI) were pooled using the Mantel-Haenszel random-effects model. Heterogeneity was assessed using the I² statistic and chi-squared test. Results: Six observational studies, including 830 patients with treatment-naïve NMIBC, were included, of whom 399 were treated with Gem-doce and 431 with BCG. Gem-doce was associated with a statistically significant improvement in CFS at 24 months (RR: 1.05; 95% CI: 1.01–1.10; p = 0.02; I² = 0%), CFS at 36 months (RR: 1.06; 95% CI: 1.02–1.11; p = 0.007; I² = 0%), PFS at 12 months (RR: 1.03; 95% CI: 1.00–1.06; p = 0.04; I² = 0%), PFS at 24 months (RR: 1.04; 95% CI: 1.01–1.08; p = 0.01; I² = 0%), and PFS at 36 months (RR: 1.10; 95% CI: 1.03–1.17; p = 0.003; I² = 33%). BCG was associated with an improvement in OS at 24 months (RR: 0.93; 95% CI: 0.88–0.99; p = 0.02; I² = 0%). In terms of HG-RFS, RFS, and CSS, no significant differences were found between the two groups. Conclusions: Our meta-analysis indicates that Gem-doce significantly improves CFS and PFS compared to BCG in NMIBC, while BCG shows better OS at 24 months. Further studies are needed to explore the long-term survival benefits of Gem-doce.