Simulation of the effects of molecular urine markers in follow-up of patients with high-risk non-muscle invasive bladder cancer.

A plethora of urine markers for the management of patients with bladder cancer has been developed and studied in the past. However, the clinical impact of urine testing on patient management remains obscure. The goal of this manuscript is to identify scenarios for the potential use of molecular urine markers in the follow-up of patients with high-risk non-muscle-invasive BC (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 the 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 (SOC) at 1 year was calculated at 96%. For different marker-supported strategies sensitivities ranging from 77% to 97.9% were estimated. Calculations suggest that several strategies are effective for the SOC. While for the SOC 24.6 WLCs were required to diagnose 1 tumor recurrence (NND), this NND dropped below 5 in some marker-supported strategies. 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 WLCs. Further research focusing on prospective randomized trials is needed to finally find a way to implement urine markers into clinical decision-making.

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Copyright © 2024. Published by Elsevier Inc.

Déclaration de conflit d'intérêts

Declaration of competing interest Thorsten Ecke is trialist for Concile GmbH, Germany. Florian Roghmann is trialist for Cepheid, CA, USA. Bas W.G. van. Rhijn is consultant for QED Therapeutics, CA, USA and Incyte International Biosciences, DE, USA. Arnulf Stenzl is trialist and consultant for Arquer Ltd, UK, Cepheid, CA, USA and Nucleix Inc., Israel. J. Alfred Witjes is trialist and consultant for Arquer Ltd, UK, Cepheid, CA, USA and Nucleix Inc., Israel. Peter J. Goebell is trialist for Cepheid, CA, USA. Jorgen Bjerggaard Jensen is trialist and consultant for Cepheid, CA, USA and Nucleix Inc., Israel. Bernd J. Schmitz-Dräger is trialist and consultant for Arquer Ltd, UK, Cepheid, CA, USA, Concile GmbH, Germany and Nucleix Inc., Israel. Remaining authors have no conflict of interest to disclose.