In a Danish study (DaBlaCa-13) reported in the Journal of Clinical Oncology, Lindgren et al found that short-term intensive chemoresection with mitomycin reduced the need for surgical procedures in patients with recurrent non–muscle-invasive bladder cancer.
Study Details
The trial was conducted at two sites in Denmark between January 2018 and August 2021. A total of 119 patients with a history of stage Ta low- or high-grade disease were enrolled upon recurrence.
Patients were randomly assigned to receive either:
- Intravesical mitomycin at 40 mg/40 mL three times a week for 2 weeks and transurethral resection of bladder tumor (TURBT) or office biopsy only if response was incomplete (intervention group, n = 58)
- TURBT or office biopsy and 6 weekly adjuvant instillations of mitomycin for low-grade and Bacillus Calmette-Guérin for high-grade tumors (control group, n = 61).
The primary outcome measure was the proportion of patients undergoing a surgical procedure (TURBT or office biopsy with tumor fulguration) within 2 years from inclusion. Recurrence-free survival at 12 months was compared between groups.
Key Findings
Overall, procedures were performed in 71% (95% confidence interval [CI] = 57%–81%) of patients in the intervention group and in 100% (95% CI = 94%–100%) of patients in the control group (P < .001).
No difference between groups was observed in proportions of patients requiring a procedure due to subsequent recurrence; such procedures were required in 37 patients in the intervention group (64%) vs 35 (57%) in the control group (P = .5). During follow-up, TURBT was performed in 26 patients in the intervention group (45%) vs 21 (34%) in the control group (P = .2).
Twelve-month recurrence-free survival was 36% (95% CI = 24%–50%) in the intervention group vs 43% (95% CI = 30%–56%) in the control group (P = .5).
The investigators concluded, “Short-term intensive chemoresection is an effective treatment strategy for recurrent non–muscle-invasive bladder cancer that leads to a reduced number of required procedures without compromising long-term oncological safety.”
Maria S. Lindgren, MD, of the Department of Urology, Aarhus University Hospital, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Danish Cancer Society, Medac GmbH Germany, and others. For full disclosures of the study authors, visit ascopubs.org.
