Assessment of Xpert Bladder Cancer Monitor test performance for the detection of recurrence during non-muscle invasive bladder cancer follow-up

F Vanie,Olivier Cussenot,M Roupret,E Compérat,C Gaffory,U Pinar,G Cancel-Tassin,V Ondet

doi:10.1007/s00345-021-03629-1

Abstract

PurposeTo assess the performance of the Xpert Bladder Cancer (BC) Monitor during the follow-up of patients with non-muscle invasive bladder cancer (NMIBC).MethodsPatients with previously diagnosed NMIBC and followed up in clinical practice settings in two French urology departments between September 2017 and July 2019 were consecutively enrolled in this prospective observational study. Patients with a positive cystoscopy or computed tomography urogram underwent subsequent transurethral resection of the bladder, and/or biopsy, and the specimens were pathologically assessed. Cytology and Xpert BC Monitor tests were performed on urine samples. Xpert BC Monitor performance was assessed versus cystoscopy for disease-negative patients or versus histology for disease-positive patients, and was compared to that of cytology.ResultsOverall, 500 patients with a median age of 70.0 years were included. NMIBC recurrence was diagnosed in 44 cases (8.8%). Overall sensitivity, specificity, and negative predictive values (NPVs) were 72.7% (32/44), 73.7% (330/448) and 96.5% (330/342) for the Xpert BC Monitor, and 7.7% (2/26), 97.8% (310/317) and 92.8% (310/334) for cytology, respectively. The Xpert BC Monitor detected 92.3% (12/13) of the high-grade tumours and ruled out their presence in 99.7% (330/331) of cases. Analysis of the areas under the receiver operating characteristic curves demonstrated the superior performance of the Xpert BC Monitor over that of cytology.ConclusionXpert BC Monitor performance was superior to that of cytology in the follow-up of NMIBC. The exclusion of aggressive tumours with a very high NPV (99.7%) supports the use of this urinary test in daily practice.

Highlights

75% of newly diagnosed bladder cancers are non-muscle invasive bladder cancers (NMIBCs) [1]
Urinary tests are used in the follow-up of NMIBC patients with the aim of reducing the frequency of such invasive testing, while still allowing the early detection of disease recurrence, the presence of recurrence to be excluded, and the detection of progression [14, 15]
Our results showed that the Xpert Bladder Cancer (BC) Monitor test performed well, regardless of whether the analysis was based on the initial EORTC risk group or the highest EORTC risk group during NMIBC surveillance

Summary

Introduction

75% of newly diagnosed bladder cancers are non-muscle invasive bladder cancers (NMIBCs) [1]. The 5-year recurrence (31–78%) and progression (0.8–45%) rates of NMIBC are high [2], requiring diligent and accurate. AP-HP, Hôpital Pitié-Salpêtrière, 75013 Paris, France follow-up for early detection as well as treatment of recurrence and/or progression. The follow-up schedule should be adapted according to the predicted European Organisation for Research and Treatment of Cancer (EORTC) risk score (i.e., low, intermediate or high) assigned at tumour diagnosis [2], and specific guidelines [3]. White light cystoscopy and urine cytology are the gold standard for patient surveillance after NMIBC diagnosis [3]. White light cystoscopy demonstrates a lack of sensitivity for flat lesions [7]. The procedure is unpleasant for patients, which can lead to non-compliance with followup schedules. Surveillance of NMIBC patients with these methodologies is costly [8]

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Results

Conclusion