Systematic review and meta-analysis compares intravesical gemcitabine/docetaxel versus BCG for non-muscle-invasive bladder cancer
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Key Takeaway
Consider intravesical gemcitabine/docetaxel as an alternative to BCG for high-risk non-muscle-invasive bladder cancer.
This systematic review and meta-analysis examined the efficacy and safety of intravesical gemcitabine and docetaxel versus Bacillus Calmette-Guérin (BCG) therapy for non-muscle-invasive bladder cancer. The pooled analysis included 1634 patients, comprising 999 receiving gemcitabine/docetaxel and 635 receiving BCG. The primary outcome was recurrence-free survival, with secondary outcomes including high-grade recurrence-free survival, progression-free survival, and adverse events. The follow-up duration was 24.0 months.
In high-risk BCG-naïve patients, 24-month recurrence-free survival was 78% (95% CI: 70%-84%) for the gemcitabine/docetaxel group. In high-risk BCG-treated or unresponsive patients, the rate was 41% (95% CI: 34%-47%). Progression-free survival at 24 months was 97% (95% CI: 69%-100%) for BCG-naïve patients and 85% (95% CI: 63%-95%) for BCG-treated patients. A comparison in BCG-naïve intermediate to very-high-risk disease showed no significant difference in recurrence-free survival, with a hazard ratio of 0.87 (95% CI: 0.51-1.50).
Safety analysis revealed that Grade ≥ 3 adverse events occurred in 3.6% of gemcitabine/docetaxel cohorts. The risk of adverse events showed no significant difference between groups, with an odds ratio of 0.58 (95% CI: 0.21-1.60). The authors noted that maintenance effects were derived from between-study comparisons and should be interpreted cautiously due to heterogeneity in maintenance protocols and adherence. Funding or conflicts were not reported.
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View Original Abstract ↓
This meta-analysis evaluated the oncological outcomes and safety profile of intravesical gemcitabine and docetaxel (Gem/Doce) in patients with non-muscle-invasive bladder cancer (NMIBC). Additionally, efficacy comparison to Bacillus Calmette-Guérin (BCG) therapy was aimed only for BCG-naïve NMIBC. A systematic review and meta-analysis were conducted following PRISMA guidelines. Studies evaluating Gem/Doce for NMIBC were identified through PubMed, Web of Science, and Scopus databases. The primary outcome was recurrence-free survival (RFS). Secondary outcomes were high-grade RFS (HG-RFS), progression-free survival (PFS) and risk of adverse events (AEs). A subgroup analysis was performed according to the European Association of Urology (EAU) 2021 risk stratification and previous BCG exposure. A total of 14 studies, involving 1634 NMIBC patients (999 Gem/Doce and 635 BCG), were included. In high-risk BCG-naïve and BCG-treated (BCG-exposed/-unresponsive) NMIBC, Gem/Doce resulted in 24-month RFS of 78% (95% confidence intervals [CI] 70%-84%) and 41% (95% CI: 34%-47%), and 24-month PFS of 97% (95% CI: 69%-100%) and 85% (95% CI: 63%-95%), respectively. Five studies, including BCG-naïve intermediate to very-high-risk NMIBC, directly compared Gem/Doce and BCG, and demonstrated significant heterogeneity and no significant difference in RFS (Hazard ratio: 0.87, 95% CI: 0.51-1.50) and risk of AEs (odds ratio: 0.58, 95% CI: 0.21-1.60). Grade ≥ 3 AEs were found in 3.6% of Gem/Doce cohorts. Across Gem/Doce cohorts, higher maintenance utilization was associated with significantly improved RFS at 24 months (p = .004). However, maintenance effects were derived from between-study comparisons and should be interpreted cautiously due to heterogeneity in maintenance protocols and adherence. Gem/Doce provided acceptable RFS and PFS at 2 years among BCG-naïve patients and those who previously experienced recurrence after BCG. Gem/Doce demonstrated RFS and HG-RFS comparable to BCG in BCG-naïve NMIBC and had an acceptable safety profile.
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