Postinduction Urine Tumor DNA Is Predictive for Response to Maintenance Intravesical Therapy in Non-muscle-invasive Bladder Cancer

Why clinicians should know about it

• Picked for Urology (paper of the day, 2 November 2026): Prospective bladder cancer study informs maintenance therapy and de-escalation

Abstract

Non-muscle-invasive bladder cancer has a high recurrence risk and is typically managed with transurethral resection of bladder tumors followed by intravesical therapy (IVT) induction. Thereafter, guidelines support maintenance IVT, but real-world adherence is reported as low as 2%. Management is complicated by ambiguity regarding which patients derive the greatest benefit, highlighting the need for biomarkers to inform management decisions. Postinduction urine tumor DNA (utDNA) was evaluated as a predictor of maintenance benefit in INSITE, a prospectively designed multicenter observational study. utDNA status was determined using a previously validated algorithm. The primary outcome was recurrence-free survival (RFS). Among 140 evaluable patients, 47% received maintenance IVT. For patients with utDNA-negative status, maintenance therapy provided no significant RFS benefit (hazard ratio [HR] 1.35, 95% confidence interval [CI] = 0.50-3.64, p = 0.6), and RFS was 88% at 24 mo regardless of whether patients received maintenance. Conversely, patients with utDNA-positive status who received maintenance experienced a survival advantage over those who did not (HR 0.22, 95% CI = 0.09-0.52, p < 0.001). RFS was 68% in patients with utDNA-positive status who received maintenance but was just 16% in those who remained untreated at 24 mo. Traditional clinicopathologic risk factors were not significantly associated with recurrence. Postinduction utDNA identifies patients who benefit from maintenance therapy versus those who may consider de-escalation, enabling personalized care within guideline ranges.

Abstract as published, via PubMed.