Optimal urine-based diagnostic tests (UBDT) minimize unnecessary follow-up cystoscopies in patients with non-muscle-invasive bladder-cancer (NMIBC), while accurately detecting high-grade bladder-cancer without false-negative results. Such UBDTs have not been comprehensively described upon a broad, validated dataset, resulting in cautious guideline recommendations. Uromonitor®, a urine-based DNA-assay detecting hotspot alterations in TERT, FGFR3, and KRAS, shows promising initial results. However, a systematic review merging all available data is lacking. Studies investigating the diagnostic performance of Uromonitor® in NMIBC until November 2023 were identified in PubMed, Embase, Web-of-Science, Cochrane, Scopus, and medRxiv databases. Within aggregated analyses, test performance and area under the curve/AUC were calculated. This project fully implemented the PRISMA statement. Four qualifying studies comprised a total of 1190 urinary tests (bladder-cancer prevalence: 14.9%). Based on comprehensive analyses, sensitivity, specificity, positive-predictive value/PPV, negative-predictive value/NPV, and test accuracy of Uromonitor® were 80.2%, 96.9%, 82.1%, 96.6%, and 94.5%, respectively, with an AUC of 0.886 (95%-CI: 0.851-0.921). In a meta-analysis of two studies comparing test performance with urinary cytology, Uromonitor® significantly outperformed urinary cytology in sensitivity, PPV, and test accuracy, while no significant differences were observed for specificity and NPV. This systematic review supports the use of Uromonitor® considering its favorable diagnostic performance. In a cohort of 1000 patients with a bladder-cancer prevalence of ~15%, this UBDT would avert 825 unnecessary cystoscopies (true-negatives) while missing 30 bladder-cancer cases (false-negatives). Due to currently limited aggregated data from only four studies with heterogeneous quality, confirmatory studies are needed.
Cancers. 2024 Feb 11*** epublish ***
Anton P Kravchuk, Ingmar Wolff, Christian Gilfrich, Ralph M Wirtz, Paula Soares, Kay-Patrick Braun, Sabine D Brookman-May, Lisa Kollitsch, Katharina Hauner, Martin Burchardt, Johannes Bründl, Maximilian Burger, Matthias May
Department of Urology, St. Elisabeth Hospital Straubing, 94315 Straubing, Germany., Department of Urology, University Medicine Greifswald, 17475 Greifswald, Germany., STRATIFYER Molecular Pathology GmbH, 50935 Cologne, Germany., IPATIMUP-Institute of Molecular Pathology and Immunology, University of Porto, 4200-135 Porto, Portugal., Institute of General Practice, Otto-von-Guericke-University Magdeburg, 39120 Magdeburg, Germany., Department of Urology, Ludwig-Maximilians-University, 81377 Munich, Germany., Department of Urology and Andrology, Klinik Donaustadt, A1220 Vienna, Austria., Department of Urology, University Hospital MRI-TUM (München rechts der Isar), 81675 Munich, Germany., Department of Urology, Caritas St. Josef Medical Centre, University of Regensburg, 93053 Regensburg, Germany.