Real-world performance of Uromonitor® in urothelial bladder cancer detection: a multicentric trial.

Autor: Wolff I; Department of Urology, University Medicine Greifswald, Greifswald, Germany., Kravchuk AP; Department of Urology, St. Elisabeth Hospital Straubing, Brothers of Mercy Hospital, Straubing, Germany., Wirtz RM; STRATIFYER Molecular Pathology GmbH, Cologne, Germany., Schlomm T; Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany., Rabien A; Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany., Rong D; Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany., Hofbauer SL; Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany., Labonté FK; Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany., Barski D; Department of Urology, Rheinland Clinic Neuss, Neuss, Germany., Otto T; Department of Urology, Rheinland Clinic Neuss, Neuss, Germany.; Medical School, University of Duisburg-Essen, Essen, Germany., Gössl A; Department of Urology, Rheinland Clinic Neuss, Neuss, Germany., Brookman-May SD; Department of Urology, University of Munich, LMU, Munich, Germany.; Johnson and Johnson Innovative Medicine, Research & Development, Spring House, PA, USA., Gilfrich CP; Department of Urology, St. Elisabeth Hospital Straubing, Brothers of Mercy Hospital, Straubing, Germany., Ecke TH; Department of Urology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.; Department of Urology, Helios Hospital, Bad Saarow, Germany., May M; Department of Urology, St. Elisabeth Hospital Straubing, Brothers of Mercy Hospital, Straubing, Germany.; Teaching Hospital of the University Clinic Regensburg, Chair of Urology at the Caritas St. Josef Medical Center, Regensburg, Germany.
Jazyk: angličtina
Zdroj: BJU international [BJU Int] 2024 Dec; Vol. 134 (6), pp. 992-1000. Date of Electronic Publication: 2024 Jun 24.
DOI: 10.1111/bju.16450
Abstrakt: Objectives: To compare Uromonitor® (U-Monitor Lda, Porto, Portugal), a multitarget DNA assay that detects mutated proto-oncogenes (telomerase reverse transcriptase [TERT], fibroblast growth factor receptor 3 [FGFR-3], Kirsten rat sarcoma viral oncogene homologue [KRAS]), with urine cytology in the urine-based diagnosis of urothelial carcinoma of the bladder (UCB) within a multicentre real-world setting.
Patients and Methods: This multicentre, prospective, double-blind study was conducted across four German urological centres from 2019 to 2024. We evaluated the diagnostic performance of Uromonitor compared to urine cytology in a cohort of patients with UCB and in healthy controls within a real-world setting. Sensitivity, specificity, positive-predictive value (PPV), negative-predictive value (NPV), and accuracy of the tests were measured, in addition to multivariate analyses to assess the ability of individual proto-oncogene mutations in detecting UCB. The biometric sample size was designed to achieve a 10% difference in sensitivity.
Results: Patients with UCB comprised 63.7% (339/532) of the study group. Uromonitor showed a sensitivity, specificity, PPV, NPV, accuracy, and an area-under-the-curve of 49.3%, 93.3%, 92.8%, 51.1%, 65.2%, and 0.713%, respectively. These metrics did not demonstrate statistical superiority over urine cytology in terms of sensitivity (44.6%; P = 0.316). Moreover, the comparison of additional test parameters, as well as the comparison within various sensitivity analyses, yielded no significant disparity between the two urinary tests. Multivariate logistic regression underscored the significant predictive value of a positive Uromonitor for detecting UCB (odds ratio [OR] 9.03; P < 0.001). Furthermore, mutations in TERT and FGFR-3 were independently associated with high odds of UCB detection (OR 13.30 and 7.04, respectively), while KRAS mutations did not exhibit predictive capability.
Conclusion: Despite its innovative approach, Uromonitor fell short of confirming the superior results anticipated from previous studies in this real-world setting. The search for an optimal urine-based biomarker for detecting and monitoring UCB remains ongoing. Results from this study highlight the complexity of developing non-invasive diagnostic tools and emphasise the importance of continued research efforts to refine these technologies.
(© 2024 BJU International.)
Databáze: MEDLINE
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