Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non-muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis.

During 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.

To 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).

PubMed, 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.

Twenty-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.

Our 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.

Novel 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.

European urology oncology. 2021 Nov 06 [Epub ahead of print]

Ekaterina Laukhtina, Sung Ryul Shim, Keiichiro Mori, David D'Andrea, Francesco Soria, Pawel Rajwa, Hadi Mostafaei, Eva Compérat, Alessia Cimadamore, Marco Moschini, Jeremy Yuen-Chun Teoh, Dmitry Enikeev, Evanguelos Xylinas, Yair Lotan, Juan Palou, Paolo Gontero, Marko Babjuk, J Alfred Witjes, Ashish M Kamat, Morgan Roupret, Shahrokh F Shariat, Benjamin Pradere, European Association of Urology–Young Academic Urologists (EAU-YAU): Urothelial Carcinoma Working Group

Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia., Department of Preventive Medicine, Korea University College of Medicine, Seoul, Korea., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, The Jikei University School of Medicine, Tokyo, Japan., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria., Division of Urology, Department of Surgical Sciences, San Giovanni Battista Hospital, University of Studies of Torino, Turin, Italy., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Medical University of Silesia, Zabrze, Poland., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Research Center for Evidence Based Medicine, Tabriz University of Medical Sciences, Tabriz, Iran., Department of Pathology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria., Section of Pathological Anatomy, Marche Polytechnic University, School of Medicine, United Hospitals, Ancona, Italy., Department of Urology and Division of Experimental Oncology, Urological Research Institute, Vita-Salute San Raffaele, Milan, Italy., S.H. Ho Urology Centre, Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China., Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia., Department of Urology, Bichat-Claude Bernard Hospital, Assistance-Publique-Hôpitaux de Paris, Université de Paris, Paris, France., Department of Urology, University of Texas Southwestern, Dallas, TX, USA., Fundació Puigvert, Department of Urology, Autonomous University of Barcelona, Barcelona, Spain., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Department of Urology, Hospital Motol, Second Faculty of Medicine, Charles University, Prague, Czech Republic., Department of Urology, Radboud University, Nijmegen Heyendaal, The Netherlands., Department of Urology, M.D. Anderson Cancer Center, University of Texas, Houston, TX, USA., Urology, GRC n°5, Predictive Onco-Urology, Ap-Hp, Hôpital Pitié-Salpêtrière, Sorbonne Université, Paris, France., Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria; Institute for Urology and Reproductive Health, Sechenov University, Moscow, Russia; Department of Urology, Hospital Motol, Second Faculty of Medicine, Charles University, Prague, Czech Republic; Karl Landsteiner Institute of Urology and Andrology, Vienna, Austria; Department of Urology, Weill Cornell Medical College, New York, NY, USA; Department of Urology, University of Texas Southwestern, Dallas, TX, USA; Hourani Center for Applied Scientific Research, Al-Ahliyya Amman University, Amman, Jordan. Electronic address: .

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