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DaBlaCa-13 Study: Five-year Follow-up from the Randomized Controlled Trial of Chemoresection with Intravesical
Søren Klingenberg1, Maria S Lindgren2, Jakob K Jakobsen1
1Department of Urology, Aarhus University Hospital, Aarhus N, Denmark; Department of Clinical Medicine, Aarhus University, Aarhus C, Denmark.
Background And Objective:
Transurethral resection of bladder tumors (TURBT) remains the standard treatment for non-muscle-invasive bladder cancer (NMIBC) but is associated with procedural risks and health care burden. Chemoresection using intravesical mitomycin C (MMC) has emerged as a minimally invasive alternative. This randomized controlled trial presents 5-yr follow-up data evaluating long-term outcomes of MMC chemoresection versus standard surgical management in patients with intermediate-risk NMIBC.
Methods:
From 2018 to 2024, 120 patients with recurrent Ta low-grade or high-grade NMIBC and >1 papillary tumor <2 cm were randomized 1:1 to receive either short-term, intensive chemoresection (6 MMC instillations over 2 wk) or standard care with TURBT/biopsy followed by adjuvant instillations with a 5-yr follow-up. Primary end points were the number of procedures (TURBT or biopsy/fulguration) and recurrence-free survival (RFS).
Key Findings And Limitations:
Fewer patients in the intervention group underwent TURBT (64% vs 89%, p = 0.003), and more patients avoided procedures entirely (17% vs 0%, p = 0.002). Nonresponders shifted from TURBT to office procedures (p = 0.029). At 5 yr, RFS was 14% vs 28% (p = 0.3), with no statistically significant between-group difference (hazard ratio = 1.32, 95% confidence interval 0.86-2.01). Patients with fewer baseline tumors had better RFS (p = 0.012). Findings are limited by a few high-grade tumors at baseline.
Conclusions And Clinical Implications:
Chemoresection reduces the need for surgical procedures in patients with recurrent NMIBC without compromising long-term oncological outcomes. These findings support its integration as a less-invasive treatment option in selected patients.
