Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients.

Caroline A Sieverink,J Alfred Witjes,Ricardo R Leão,João Vinagre,Paula Soares,Rui P M Batista,Cristina Sampaio,Hugo J M Prazeres,Valdemar Máximo

doi:10.3390/diagnostics10100745

Abstract

The costly and burdensome nature of the current follow-up methods in non-muscle-invasive bladder cancer (NMIBC) drives the development of new methods that may alternate with regular cystoscopy and urine cytology. The Uromonitor-V2® is a new urine-based assay in the detection of hotspot mutations in three genes (TERT, FGFR3, and KRAS) for evaluation of disease recurrence. The aim of this study was to investigate the Uromonitor-V2®’s performance in detecting NMIBC recurrence and compare it with urine cytology. From February 2018 to September 2019 patients were enrolled. All subjects underwent a standard-of-care (SOC) cystoscopy, either as part of their follow-up for NMIBC or for a nonmalignant urological pathology. Urine cytology was performed in NMIBC patients. Out of the 105 patients enrolled, 97 were eligible for the study. Twenty patients presented nonmalignant lesions, 29 had a history of NMIBC with disease recurrence, and 49 had a history of NMIBC without recurrence. In NMIBC, the Uromonitor-V2® displayed a sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 93.1%, 85.4%, 79.4%, and 95.3%, respectively. Urine cytology was available for 52 patients, and the sensitivity, specificity, PPV, and NPV were 26.3%, 90.9%, 62.5%, and 68.2%, respectively. With its high NPV of 95.3%, the Uromonitor-V2® revealed promising properties for the follow-up of patients with NMIBC.

Highlights

Bladder cancer (BCa) is the tenth most common type of cancer worldwide with more than 500,000 newly diagnosed cases in 2018 [1]
The current follow-up schedule of patients with a history of non-muscle-invasive bladder cancer (NMIBC) consists of regular surveillance cystoscopies in combination with urine cytology
Follow-up through regular cystoscopies and cytology should be maintained years following diagnosis and can even span throughout life [8]. These extensive schemes lead to high costs, making BCa the most expensive cancer when considering patients’ lifetime expenses [9]. Another drawback of the current follow-up is the invasive nature of the cystoscopic procedure and the low sensitivity of urine cytology, in low-grade NMIBC [10]

Summary

Introduction

Bladder cancer (BCa) is the tenth most common type of cancer worldwide with more than 500,000 newly diagnosed cases in 2018 [1]. Follow-up through regular cystoscopies and cytology should be maintained years following diagnosis and can even span throughout life [8]. These extensive schemes lead to high costs, making BCa the most expensive cancer when considering patients’ lifetime expenses [9]. Another drawback of the current follow-up is the invasive nature of the cystoscopic procedure and the low sensitivity of urine cytology, in low-grade NMIBC [10]. For biomarker-based tests that aim to (partially) replace cystoscopies in the follow-up of NMIBC, a high negative predictive value (NPV) should be mandatory. Tests like the NMP22 BladderCheck, UroVysion, or BTA stat failed to be implemented into clinical practice due to insufficient NPV and low specificity

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