Yair Lotan1, Paul OʼSullivan2, Jay D Raman3, Sharokh F Shariat4, Laimonis Kavalieris2, Chris Frampton5, Parry Guilford6, Carthika Luxmanan2, James Suttie7, Henry Crist3, Douglas Scherr8, Scott Asroff9, Evan Goldfischer10, Jeffrey Thill11, David Darling2. 1. Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX. 2. Pacific Edge Ltd., Dunedin, New Zealand. 3. Penn State Milton S. Hershey Medical Center, Hershey, PA. 4. Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX; Department of Urology, Weill Cornell Medical College, Cornell University, New York, NY; Department of Urology, Medical University of Vienna, Vienna, Austria. 5. Department of Psychological Medicine, University of Otago, Christchurch, New Zealand. 6. Pacific Edge Ltd., Dunedin, New Zealand; Department of Biochemistry, University of Otago, Dunedin, New Zealand. 7. Pacific Edge Ltd., Dunedin, New Zealand. Electronic address: jimmy.suttie@pelnz.com. 8. Department of Urology, Weill Cornell Medical College, Cornell University, New York, NY. 9. Delaware Valley Urology, Mount Laurel, NJ. 10. Premier Medical Group of the Hudson Valley, Poughkeepsie, NY. 11. Florida Urology Associates, Orlando, FL.
Abstract
OBJECTIVE: Patients with urothelial carcinoma (UC) undergo rigorous surveillance for recurrence. Noninvasive urine tests are not currently recommended by guideline panels owing to insufficient clinical benefit. The objective of this study was to prospectively compare the performance of the Cxbladder Monitor test to other commonly available urine markers and cytology for surveillance of patients with UC. METHODS AND MATERIALS: A total of 1,036 urine samples were collected from 803 patients undergoing surveillance for UC. Of these, 1,016 samples were directly assessed using cytology, NMP22 Bladderchek and NMP22 enzyme-linked immunosorbent assay (ELISA), and the clinically validated Cxbladder Monitor test. An exploratory analysis was also performed comparing data from 157 samples where UroVysion fluorescence in situ hybridization analysis was performed locally. RESULTS: The sensitivity of Cxbladder Monitor (0.91) significantly outperformed cytology (0.22), NMP22 ELISA (0.26), and NMP22 BladderChek (0.11). The negative predictive value of Cxbladder Monitor was also superior at 0.96 compared with cytology (0.87), NMP22 ELISA (0.87), and NMP22 BladderChek (0.86). All false-negative results (n = 14) observed using Cxbladder Monitor were also negative for cytology, NMP22 ELISA, and NMP22 BladderChek. In the more limited set, UroVysion fluorescence in situ hybridization also had inferior sensitivity (0.33) and negative predictive value (0.92). CONCLUSIONS: The Cxbladder Monitor test significantly outperforms current Food and Drug Administration-approved urine-based monitoring tests, as well as cytology, in a large representative population undergoing surveillance for recurrent UC. This supports using Cxbladder Monitor as a confirmatory negative adjunct to cystoscopy or to justify postponing cystoscopic investigations in patients with a low risk of recurrence.
OBJECTIVE:Patients with urothelial carcinoma (UC) undergo rigorous surveillance for recurrence. Noninvasive urine tests are not currently recommended by guideline panels owing to insufficient clinical benefit. The objective of this study was to prospectively compare the performance of the Cxbladder Monitor test to other commonly available urine markers and cytology for surveillance of patients with UC. METHODS AND MATERIALS: A total of 1,036 urine samples were collected from 803 patients undergoing surveillance for UC. Of these, 1,016 samples were directly assessed using cytology, NMP22 Bladderchek and NMP22 enzyme-linked immunosorbent assay (ELISA), and the clinically validated Cxbladder Monitor test. An exploratory analysis was also performed comparing data from 157 samples where UroVysion fluorescence in situ hybridization analysis was performed locally. RESULTS: The sensitivity of Cxbladder Monitor (0.91) significantly outperformed cytology (0.22), NMP22 ELISA (0.26), and NMP22 BladderChek (0.11). The negative predictive value of Cxbladder Monitor was also superior at 0.96 compared with cytology (0.87), NMP22 ELISA (0.87), and NMP22 BladderChek (0.86). All false-negative results (n = 14) observed using Cxbladder Monitor were also negative for cytology, NMP22 ELISA, and NMP22 BladderChek. In the more limited set, UroVysion fluorescence in situ hybridization also had inferior sensitivity (0.33) and negative predictive value (0.92). CONCLUSIONS: The Cxbladder Monitor test significantly outperforms current Food and Drug Administration-approved urine-based monitoring tests, as well as cytology, in a large representative population undergoing surveillance for recurrent UC. This supports using Cxbladder Monitor as a confirmatory negative adjunct to cystoscopy or to justify postponing cystoscopic investigations in patients with a low risk of recurrence.
Authors: Susanne Deininger; J Hennenlotter; S Rausch; K Docktor; E Neumann; I A da Costa; J Bedke; A Stenzl; T Todenhöfer Journal: J Cancer Res Clin Oncol Date: 2018-04-19 Impact factor: 4.553
Authors: C A Chai; W S Yeoh; R Rajandram; K P Aung; T A Ong; S Kuppusamy; A Nazran; K Kumaran; A H A Razack; J Y Teoh Journal: Front Surg Date: 2021-05-13