Improving detection of carcinoma in situ in bladder cancer: urinary cytology vs the Xpert® BC Monitor

Maximilian Haas; Maximilian C Kriegmair; Johannes Breyer; Danijel Sikic; Felix Wezel; Florian Roghmann; Mirco Brehmer; Ralph M Wirtz; Jonas Jarczyk; Philipp Erben; Veronika Bahlinger; Franziska Goldschmidt; Guido Fechner; Jack Chen; Ellen Paxinos; Michael Bates; Friedemann Zengerling; Christian Bolenz; Maximilian Burger; Arndt Hartmann; Markus Eckstein

doi:10.1111/bju.16389

Improving detection of carcinoma in situ in bladder cancer: urinary cytology vs the Xpert® BC Monitor

BJU Int. 2024 May 8. doi: 10.1111/bju.16389. Online ahead of print.

Authors

Maximilian Haas¹, Maximilian C Kriegmair^{2

3}, Johannes Breyer¹, Danijel Sikic⁴, Felix Wezel⁵, Florian Roghmann⁶, Mirco Brehmer⁶, Ralph M Wirtz^{7

8}, Jonas Jarczyk², Philipp Erben², Veronika Bahlinger⁹, Franziska Goldschmidt¹⁰, Guido Fechner¹⁰, Jack Chen¹¹, Ellen Paxinos¹², Michael Bates¹², Friedemann Zengerling⁵, Christian Bolenz⁵, Maximilian Burger¹, Arndt Hartmann⁹, Markus Eckstein⁹

Affiliations

¹ Department of Urology, Caritas St. Josef Medical Center, University of Regensburg, Regensburg, Germany.
² Department of Urology and Urosurgery, Medical Faculty Mannheim, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany.
³ Urological Hospital Munich-Planegg, Munich, Germany.
⁴ Department of Urology and Pediatric Urology, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
⁵ Department of Urology and Pediatric Urology, University of Ulm, Ulm, Germany.
⁶ Department of Urology, Marien Hospital, Ruhr-University Bochum, Herne, Germany.
⁷ Stratifyer Molecular Pathology GmbH, Cologne, Germany.
⁸ Institute of Pathology, St. Elisabeth Hospital Köln-Hohenlind, Cologne, Germany.
⁹ Institute of Pathology, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
¹⁰ Department of Urology and Pediatric Urology, University Hospital Bonn, Bonn, Germany.
¹¹ Biostatistics, Cepheid Inc., Sunnyvale, CA, USA.
¹² Medical and Scientific Affairs, Cepheid Inc., Sunnyvale, CA, USA.

PMID: 38717014
DOI: 10.1111/bju.16389

Abstract

Objective: To investigate and compare the performance of urinary cytology and the Xpert BC Monitor test in the detection of bladder cancer in various clinically significant patient cohorts, including patients with carcinoma in situ (CIS), in a prospective multicentre setting, aiming to identify potential applications in clinical practice.

Patients and methods: A total of 756 patients scheduled for transurethral resection of bladder tumour (TURBT) were prospectively screened between July 2018 and December 2020 at six German University Centres. Central urinary cytology and Xpert BC Monitor tests were performed prior to TURBT. The diagnostic performance of urinary cytology and the Xpert BC Monitor was evaluated according to sensitivity (SN), specificity (SC), negative predictive value (NPV) and positive predictive value (PPV). Statistical comparison of urinary cytology and the Xpert BC Monitor was conducted using the McNemar test.

Results: Of 756 screened patients, 733 (568 male [78%]; median [interquartile range] age 72 [62-79] years) were included. Bladder cancer was present in 482 patients (65.8%) with 258 (53.5%) high-grade tumours. Overall SN, SC, NPV and PPV were 39%, 93%, 44% and 92% for urinary cytology, and 75%, 69%, 59% and 82% for the Xpert BC Monitor. In patients with CIS (concomitant or solitary), SN, SC, NPV and PPV were 59%, 93%, 87% and 50% for urinary cytology, and 90%, 69%, 95% and 50% for the Xpert BC Monitor. The Xpert BC Monitor missed four tumours (NPV = 98%) in patients with solitary CIS, while potentially avoiding 63.3% of TURBTs in inconclusive or negative cystoscopy and a negative Xpert result.

Conclusion: Positive urinary cytology may indicate bladder cancer and should be taken seriously. The Xpert BC Monitor may represent a useful diagnostic tool for correctly identifying patients with solitary CIS and unsuspicious or inconclusive cystoscopy.

Keywords: NMIBC; Xpert; bladder cancer; carcinoma in situ; cytology; urine marker.

Grants and funding

Cepheid