IBCN 2023: Simulating The Effects of Molecular Urine Markers In Follow-Up Of Patients With High Risk Non-Muscle Invasive Bladder Cancer

(UroToday.com) There are numerous urine markers for diagnosis and follow-up of patients with bladder cancer which have been developed and studied in the past. However, the clinical impact of urine testing on patient management remains obscure until today. The goal of this study was to identify scenarios for the potential use of molecular urine markers in the follow-up of patients with high-risk non-muscle-invasive bladder cancer (NMIBC) and estimate potential risks and benefits.

Information on the course of disease of patients with high-risk NMIBC and performance data of a point-of-care test (UBC rapid™), an MCM-5 directed ELISA (ADXBLADDER™) and 2 additional novel assays targeting alterations of mRNA expression and DNA methylation (Xpert bladder cancer monitor™, Epicheck™) were retrieved from high-quality trials and/or meta-analyses. In addition, the sensitivity of white light cystoscopy (WLC) and the impact of a urine marker result on performance of WLC were estimated based on fluorescence cystoscopy data and information from the CeFub trial. This information was applied to different scenarios in patient follow-up and sensitivity, estimated number of cystoscopies and the numbers needed to diagnose were calculated.

The sensitivity of guideline-based regular follow-up standard of care (SOC) at 1 year was calculated with 91.7%. For different marker-supported strategies, sensitivities were estimated ranging from 77 to 97.9%. Calculations suggest that most strategies are equieffective or even superior to SOC. While for the SOC a number needed to diagnose (NND) of 25.9 per tumor detected was observed, the NND dropped to 4.2 in some marker-supported strategies.

In summary, based on the results of this simulation, a marker-supported follow-up of patients with HR NMIBC is safe and offers the option to significantly reduce the number of WLC. Further research focusing on prospective randomized trials and real world applications is needed to pave the way toward the inclusion of urine markers into clinical decision-making. Cost-effectiveness studies will also help pave the way towards understanding the value and cost savings in decision-making as well.

Presented by: Natalya Benderska-Söder, MD, Department of Urology, Nürnberg, Germany.