IBCN 2023: Initial Results From The Prospective Randomized UroFollow Trial Comparing Markerguided vs. Cystoscopy-Based Standard Follow-Up In Patients With Low/Intermediate Risk Bladder Cancer

(UroToday.com) A growing body of evidence suggests that current follow-up strategies for patients with non-muscle invasive bladder cancer (NMIBC) result in overdiagnosis and may trigger overtreatment. The goal of the UroFollow trial was to explore the efficacy and safety of a marker-guided follow-up in patients with low/intermediate risk NMIBC.

A total of 213 Patients with pTa/low and high grade (G1-2) NMIBC were included in the prospective randomized multicenter UroFollow trial comparing biannual marker-based follow-up (algorithm comprising UroVysion and NMP22 assays, urine cytology and ultrasound) against the current standard of care (SOC). After a 3-months cystoscopy, in the marker arm only patients with a positive algorithm result underwent cystoscopy. An end-of-study cystoscopy was recommended to all patients after 3 years.

The study was conducted between 4/2016 and 4/2022. 102 and 111 patients were randomized to the marker arm and standard of care, respectively. There were no significant differences between the two arms regarding tumor stage, grade, size, focality, and recurrent lesions of the base line tumors. Median follow-up interval was 2.5 years. Tumor recurrence rates were 30.4% vs. 29.7% in the standard of care and marker arm, respectively. Sensitivity of tumor detection in both arms based upon ITT were 96.8% vs. 78.8% with 1 vs. 5 pTa LG tumors being overlooked in the standard of care and marker arm, respectively. App. 20% of all recurrences were observed at the 3-months UC. One patient (SOC arm) was diagnosed with progression to MIBC at the 3 months UC.

In summary, UroFollow is the first randomized trial using the results of molecular urine markers for clinical decision making in patients with low/intermediate risk NMIBC. With all restrictions applying to a small-sized trial marker-guided follow-up in this cohort is a safe strategy if including the 3 months UC as an integral part of surveillance. Whether this is a value added tool in clinical practice remains to be determined.

Presented by: Bernd J. Schmitz-Dräger, MD, PhD, Nürnberg and Department of Urology and Pediatric Urology, Friedrich Alexander University, Erlangen, Germany

Written by: Stephen B. Williams, MD, MBA, MS @SWilliams_MD on Twitter during the International Bladder Cancer Network (IBCN) Annual Meeting, September 29-30, 2023, Montreal, Canada