Longitudinal follow-up and performance validation of an mRNA-based urine test (Xpert® Bladder Cancer Monitor) for surveillance in patients with non-muscle-invasive bladder cancer

Barrett Cowan, Eric Klein, Ken Jansz, Karl Westenfelder, Timothy Bradford, Chad Peterson, Douglas Scherr, Lawrence I. Karsh, Blair Egerdie, Alfred Witjes, Andrew Trainer, Richard Harris, Bernard Goldfarb, Stanley Flax, Robert Kroeger, Buffi Boyd, Joseph Liao, Sanjay Patel, Julia Bridge, Victor ReuterNeil Quigley, Sarah Brown, Suling Zhao, Malini Satya, Michael Bates, Iris M. Simon, Scott Campbell, Yair Lotan

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To evaluate the performance of the Xpert Bladder Cancer Monitor (Xpert; Cepheid, Sunnyvale, CA, USA) test as a predictor of tumour recurrence in patients with non-muscle-invasive bladder cancer (NMIBC). Patients and Methods: Patients (n = 429) undergoing surveillance for NMIBC underwent Xpert, cytology, and UroVysion testing. Patients with a positive Xpert and a negative cystoscopy result (positive-negative [PN] group, n = 66) and a control group of double negative patients (negative Xpert and cystoscopy results [NN] group) were followed for 12 months (±90 days). Results: Histology-confirmed recurrences were detected in 58 patients (13.5%). Xpert had an overall sensitivity of 60.3% and a specificity of 76.5%. The sensitivity for high-grade (HG) cancer was 87% with a negative predictive value (NPV) of 99%. Urine cytology showed an overall sensitivity of 23.2% (47.6% sensitivity for HG tumours) and a specificity of 88.3%. In the PN group, 32% (n = 21) developed a recurrence within 12 months, 11 of which were HG tumours. In the NN control group, 14% (n = 9) developed a recurrence and only two were HG tumours. The hazard ratio for developing recurrence in the PN group was 2.68 for all tumours and 6.84 for HG cancer. Conclusions: The Xpert test has a high sensitivity for detecting the recurrence of cancer and a high NPV for excluding HG cancer. In addition, the data suggest that patients with a positive Xpert assay in the setting of negative cystoscopy are at high risk for recurrence and need close surveillance.

Original languageEnglish (US)
JournalBJU international
DOIs
StateAccepted/In press - 2021

Keywords

  • #BladderCancer
  • #blcsm
  • #uroonc
  • anticipatory positive
  • liquid biopsy
  • molecular diagnostic
  • non-muscle-invasive bladder cancer
  • surveillance

ASJC Scopus subject areas

  • Urology

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