Abstract
ContextDuring the past decade, several urinary biomarker tests (UBTs) for bladder cancer have been developed and made commercially available. However, none of these is recommended by international guidelines so far. ObjectiveTo assess the diagnostic estimates of novel commercially available UBTs for diagnosis and surveillance of non–muscle-invasive bladder cancer (NMIBC) using diagnostic test accuracy (DTA) and network meta-analysis (NMA). Evidence acquisitionPubMed, Web of Science, and Scopus were searched up to April 2021 to identify studies addressing the diagnostic values of UBTs: Xpert bladder cancer, Adxbladder, Bladder EpiCheck, Uromonitor and Cxbladder Monitor, and Triage and Detect. The primary endpoint was to assess the pooled diagnostic values for disease recurrence in NMIBC patients using a DTA meta-analysis and to compare them with cytology using an NMA. The secondary endpoints were the diagnostic values for high-grade (HG) recurrence as well as for the initial detection of bladder cancer. Evidence synthesisTwenty-one studies, comprising 7330 patients, were included in the quantitative synthesis. In most of the studies, there was an unclear risk of bias. For NMIBC surveillance, novel UBTs demonstrated promising pooled diagnostic values with sensitivities up to 93%, specificities up to 84%, positive predictive values up to 67%, and negative predictive value up to 99%. Pooled estimates for the diagnosis of HG recurrence were similar to those for the diagnosis of any-grade recurrence. The analysis of the number of cystoscopies potentially avoided during the follow-up of 1000 patients showed that UBTs might be efficient in reducing the number of avoidable interventions with up to 740 cystoscopies. The NMA revealed that diagnostic values (except specificity) of the novel UBTs were significantly higher than those of cytology for the detection of NMIBC recurrence. There were too little data on UBTs in the primary diagnosis setting to allow a statistical analysis. ConclusionsOur analyses support high diagnostic accuracy of the studied novel UBTs, supporting their utility in the NMIBC surveillance setting. All of these might potentially help prevent unnecessary cystoscopies safely. There are not enough data to reliably assess their use in the primary diagnostic setting. These results have to be confirmed in a larger cohort as well as in head-to-head comparative studies. Nevertheless, our study might help policymakers and stakeholders evaluate the clinical and social impact of the implementation of these tests into daily practice. Patient summaryNovel urinary biomarker tests outperform cytology with the potential of improving routine clinical practice by preventing unnecessary cystoscopic examinations during the surveillance of non–muscle-invasive bladder cancer.
Highlights
Cystoscopy is the standard examination for the initial detection and follow-up of non–muscle-invasive bladder cancer (NMIBC) [1]
Repeated cystoscopies are uncomfortable for the patient and are one of the reasons for the high cost associated with bladder cancer, especially NMIBC [3]
Some of these urinary biomarkers, such as nuclear matrix protein 22 (NMP22), bladder tumor antigen (BTA), UroVysion, and ImmunoCyt/uCyt+ [4], have been approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA); these are commercially available as urinary biomarker tests (UBTs)
Summary
Cystoscopy is the standard examination for the initial detection and follow-up of non–muscle-invasive bladder cancer (NMIBC) [1]. Repeated cystoscopies are uncomfortable for the patient and are one of the reasons for the high cost associated with bladder cancer, especially NMIBC [3] Some of these urinary biomarkers, such as nuclear matrix protein 22 (NMP22), bladder tumor antigen (BTA), UroVysion (fluorescence in situ hybridization), and ImmunoCyt/uCyt+ [4], have been approved by the Food and Drug Administration (FDA) and European Medicines Agency (EMA); these are commercially available as urinary biomarker tests (UBTs). None of these UBTs are commonly used in daily practice; these are rarely reimbursed by payors, and have not been implemented in guidelines due to poor specificity and a lack of demonstrable clinical benefits, with some exceptions such as atypical cytology and cystoscopic findings [1,5]
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