Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma

Yair Lotan, Paul OʼSullivan, Jay Raman, Sharokh F. Shariat, Laimonis Kavalieris, Chris Frampton, Parry Guilford, Carthika Luxmanan, James Suttie, Henry Crist, Douglas Scherr, Scott Asroff, Evan Goldfischer, Jeffrey Thill, David Darling

Research output: Contribution to journalArticle

26 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)531.e15-531.e22
JournalUrologic Oncology: Seminars and Original Investigations
Volume35
Issue number8
DOIs
StatePublished - Aug 1 2017

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Urine
Carcinoma
Cell Biology
Enzyme-Linked Immunosorbent Assay
Fluorescence In Situ Hybridization
Population Surveillance
Recurrence
Cystoscopy
nuclear matrix protein 22
United States Food and Drug Administration
Guidelines

All Science Journal Classification (ASJC) codes

  • Oncology
  • Urology

Cite this

Lotan, Yair ; OʼSullivan, Paul ; Raman, Jay ; Shariat, Sharokh F. ; Kavalieris, Laimonis ; Frampton, Chris ; Guilford, Parry ; Luxmanan, Carthika ; Suttie, James ; Crist, Henry ; Scherr, Douglas ; Asroff, Scott ; Goldfischer, Evan ; Thill, Jeffrey ; Darling, David. / Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma. In: Urologic Oncology: Seminars and Original Investigations. 2017 ; Vol. 35, No. 8. pp. 531.e15-531.e22.
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title = "Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma",
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.",
author = "Yair Lotan and Paul OʼSullivan and Jay Raman and Shariat, {Sharokh F.} and Laimonis Kavalieris and Chris Frampton and Parry Guilford and Carthika Luxmanan and James Suttie and Henry Crist and Douglas Scherr and Scott Asroff and Evan Goldfischer and Jeffrey Thill and David Darling",
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Lotan, Y, OʼSullivan, P, Raman, J, Shariat, SF, Kavalieris, L, Frampton, C, Guilford, P, Luxmanan, C, Suttie, J, Crist, H, Scherr, D, Asroff, S, Goldfischer, E, Thill, J & Darling, D 2017, 'Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma', Urologic Oncology: Seminars and Original Investigations, vol. 35, no. 8, pp. 531.e15-531.e22. https://doi.org/10.1016/j.urolonc.2017.03.008

Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma. / Lotan, Yair; OʼSullivan, Paul; Raman, Jay; Shariat, Sharokh F.; Kavalieris, Laimonis; Frampton, Chris; Guilford, Parry; Luxmanan, Carthika; Suttie, James; Crist, Henry; Scherr, Douglas; Asroff, Scott; Goldfischer, Evan; Thill, Jeffrey; Darling, David.

In: Urologic Oncology: Seminars and Original Investigations, Vol. 35, No. 8, 01.08.2017, p. 531.e15-531.e22.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Clinical comparison of noninvasive urine tests for ruling out recurrent urothelial carcinoma

AU - Lotan, Yair

AU - OʼSullivan, Paul

AU - Raman, Jay

AU - Shariat, Sharokh F.

AU - Kavalieris, Laimonis

AU - Frampton, Chris

AU - Guilford, Parry

AU - Luxmanan, Carthika

AU - Suttie, James

AU - Crist, Henry

AU - Scherr, Douglas

AU - Asroff, Scott

AU - Goldfischer, Evan

AU - Thill, Jeffrey

AU - Darling, David

PY - 2017/8/1

Y1 - 2017/8/1

N2 - 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.

AB - 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.

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U2 - 10.1016/j.urolonc.2017.03.008

DO - 10.1016/j.urolonc.2017.03.008

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JO - Urologic Oncology

JF - Urologic Oncology

SN - 1078-1439

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