| Autor: |
Kravchuk AP; Department of Urology, St. Elisabeth Hospital Straubing, 94315 Straubing, Germany., Wolff I; Department of Urology, University Medicine Greifswald, 17475 Greifswald, Germany., Gilfrich C; Department of Urology, St. Elisabeth Hospital Straubing, 94315 Straubing, Germany., Wirtz RM; STRATIFYER Molecular Pathology GmbH, 50935 Cologne, Germany., Soares P; IPATIMUP-Institute of Molecular Pathology and Immunology, University of Porto, 4200-135 Porto, Portugal.; Department of Pathology and Oncology, Faculty of Medicine, University of Porto, 4200-139 Porto, Portugal., Braun KP; Institute of General Practice, Otto-von-Guericke-University Magdeburg, 39120 Magdeburg, Germany., Brookman-May SD; Department of Urology, Ludwig-Maximilians-University, 81377 Munich, Germany.; Johnson and Johnson Innovative Medicine, Research & Development, Spring House, PA 19477, USA., Kollitsch L; Department of Urology and Andrology, Klinik Donaustadt, A1220 Vienna, Austria., Hauner K; Department of Urology, University Hospital MRI-TUM (München rechts der Isar), 81675 Munich, Germany., Burchardt M; Department of Urology, University Medicine Greifswald, 17475 Greifswald, Germany., Bründl J; Department of Urology, Caritas St. Josef Medical Centre, University of Regensburg, 93053 Regensburg, Germany., Burger M; Department of Urology, Caritas St. Josef Medical Centre, University of Regensburg, 93053 Regensburg, Germany., May M; Department of Urology, St. Elisabeth Hospital Straubing, 94315 Straubing, Germany. |
| Abstrakt: |
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. |
