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Abstract
To determine whether Xpert bladder cancer monitor, a noninvasive PCR-based biomarker test, can predict the need for 2nd transurethral resection of the bladder (TURB) better than clinical assessment. Patients scheduled for TURB were prospectively screened. After initial TURB, patients were assigned to 2nd TURB or follow-up cystoscopy at 3 months (FU) by clinicians’ discretion. Central urine cytology and Xpert monitor tests were performed prior to the 1st TURB and 2nd TURB or FU, respectively. Statistical analysis to compare clinical assessment and Xpert monitor comprised sensitivity (SENS), specificity (SPEC), NPV and PPV. Of 756 screened patients, 171 were included (114 with 2nd TURB, 57 with FU). Residual tumors were detected in 34 patients who underwent 2nd TURB, and recurrent tumors were detected in 2 patients with FU. SENS and SPEC of Xpert monitor were 83.3% and 53.0%, respectively, PPV was 32.6% and NPV was 92.1%. Clinical risk assessment outperformed Xpert monitor. In patients with pTa disease at initial TURB, Xpert monitor revealed a NPV of 96%. Xpert monitor was not superior than clinical assessment in predicting the need for 2nd TURB. It might be an option to omit 2nd TURB for selected patients with pTa disease.
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1 University of Regensburg, Department of Urology, Caritas St. Josef Medical Center, Regensburg, Germany (GRID:grid.7727.5) (ISNI:0000 0001 2190 5763); BRIDGE (Bladder Cancer Research Initiative for Drug Targets Germany) Consortium E.V., Mannheim, Germany (GRID:grid.7727.5)
2 Friedrich-Alexander-Universität Erlangen-Nürnberg, Institute of Pathology, Comprehensive Cancer Center EMN, University Hospital Erlangen, Erlangen, Germany (GRID:grid.5330.5) (ISNI:0000 0001 2107 3311); BRIDGE (Bladder Cancer Research Initiative for Drug Targets Germany) Consortium E.V., Mannheim, Germany (GRID:grid.5330.5)
3 Friedrich-Alexander-University Erlangen-Nuremberg, Department of Urology and Pediatric Urology, Erlangen, Germany (GRID:grid.5330.5) (ISNI:0000 0001 2107 3311); BRIDGE (Bladder Cancer Research Initiative for Drug Targets Germany) Consortium E.V., Mannheim, Germany (GRID:grid.5330.5)
4 University Hospital Ulm, Department of Urology and Pediatric Urology, Ulm, Germany (GRID:grid.410712.1); BRIDGE (Bladder Cancer Research Initiative for Drug Targets Germany) Consortium E.V., Mannheim, Germany (GRID:grid.410712.1)
5 Ruhr-University Bochum, Department of Urology, Marien Hospital, Herne, Germany (GRID:grid.5570.7) (ISNI:0000 0004 0490 981X); BRIDGE (Bladder Cancer Research Initiative for Drug Targets Germany) Consortium E.V., Mannheim, Germany (GRID:grid.5570.7)
6 Ruhr-University Bochum, Department of Urology, Marien Hospital, Herne, Germany (GRID:grid.5570.7) (ISNI:0000 0004 0490 981X)
7 Stratifyer Molecular Pathology GmbH, Cologne, Germany (GRID:grid.518593.3); St. Elisabeth Hospital Köln-Hohenlind, Institute of Pathology, Cologne, Germany (GRID:grid.518593.3); BRIDGE (Bladder Cancer Research Initiative for Drug Targets Germany) Consortium E.V., Mannheim, Germany (GRID:grid.518593.3)
8 University of Heidelberg, Department of Urology and Urosurgery, University Hospital Mannheim Medical Faculty Mannheim, Mannheim, Germany (GRID:grid.7700.0) (ISNI:0000 0001 2190 4373); BRIDGE (Bladder Cancer Research Initiative for Drug Targets Germany) Consortium E.V., Mannheim, Germany (GRID:grid.7700.0)
9 University Hospital Bonn, Department of Urology and Pediatric Urology, Bonn, Germany (GRID:grid.15090.3d) (ISNI:0000 0000 8786 803X); BRIDGE (Bladder Cancer Research Initiative for Drug Targets Germany) Consortium E.V., Mannheim, Germany (GRID:grid.15090.3d)
10 Biostatistics, Cepheid Inc., Sunnyvale, USA (GRID:grid.419947.6) (ISNI:0000 0004 0366 841X)
11 Cepheid Inc., Medical and Scientific Affairs, Sunnyvale, USA (GRID:grid.419947.6) (ISNI:0000 0004 0366 841X)