Results of the Prospective Randomized UroFollow Trial Comparing Marker-guided Versus Cystoscopy-based Surveillance in Patients with Low/Intermediate-risk Bladder Cancer.

Abstract

Background and objective: A growing body of evidence suggests that the intensity of current follow-up in non-muscle-invasive bladder cancer (NMIBC) patients greatly exceeds clinical necessities. The UroFollow trial investigated the diagnostic accuracy of marker-based follow-up in patients with low/intermediate-risk NMIBC against the standard of care (SOC) for noninferiority (margin: <20%).

Methods: Patients with Ta low- and high-grade (G1-2) NMIBC were randomized to the SOC or 6-monthly marker-based follow-up (algorithm comprising urine markers and ultrasound; marker-based surveillance regimen [MA]). After a negative 3-mo cystoscopy (white light cystoscopy [WLC]), only patients with a positive algorithm underwent WLC in the MA. End-of-study WLC was recommended at 3 yr to recurrence-free patients. Simultaneously, several innovative urine markers were examined.

Key findings and limitations: In total, 214 patients were randomized to the SOC (n = 109) and MA (n = 105). The median follow-up was 2.4 yr; 30 and 29 cases of tumor recurrence were diagnosed in the SOC and MA arms, respectively. Sensitivity was 96.5% versus 81.5% (p = 0.1), with one and five Ta low-grade tumors being overlooked in the SOC and MA patients, respectively. No tumor progressing in stage or grade was missed. A total of 589 WLC procedures were performed in the SOC and 148 in the MA arm (p < 0.001). Among five other markers (ADX-Bladder, CellDetect, Bladder EpiCheck, UBC rapid, and Xpert bladder cancer monitor [BC-M]), Bladder EpiCheck and the Xpert BC-M showed similar performance to the algorithm.

Conclusions and clinical implications: UroFollow is the first urine marker-based randomized trial in low/intermediate-risk NMIBC patients. We conclude that 6-monthly marker-based follow-up after negative 3-mo WLC is safe in this cohort. Results of contemporary urine markers suggest that their potential for use in marker-based surveillance, however, requires prospective confirmation.