Performance Characteristics of a Multigene Urine Biomarker Test for Monitoring for Recurrent Urothelial Carcinoma in a Multicenter Study

Urothelial carcinoma is associated with a high rate of recurrence with guidelines recommending rigorous, regular surveillance programs that are invasive and expensive. This study describes a non-invasive urine test with sufficient sensitivity to 'rule out' recurrent urothelial carcinoma, thereby reducing invasive diagnostic evaluations without compromising patient care.

1036 urine samples were prospectively collected from 763 patients undergoing routine surveillance for recurrent urothelial carcinoma of the bladder to develop and validate a test with combined high sensitivity and high negative predictive value. Cxbladder Monitor combines gene expression, clinical and patient data and is designed to rule out the presence of recurrent urothelial carcinoma.

Cxbladder Monitor offers an internally validated sensitivity of 0.93 with a negative predictive value of 0.97 and a test-negative rate of 0.34. Sensitivity is 0.95 for recurrent disease with a high risk of progression (all high-grade disease and low-grade, stage ≥T1 disease) compared with 0.86 for low-grade Ta disease. Subgroup analyses indicated that diagnostic performance was not significantly different within different age groups, gender or tumor stages. The sensitivity was not affected by adjuvant Bacillus Calmette-Guérin treatment within the last 6 months. False-negatives were reported in <1.5% of all samples collected.

The Cxbladder Monitor test offers high sensitivity and high negative predictive value, combined, for ruling out urothelial carcinoma. This test has clinical utility as a confirmatory negative adjunct to cystoscopy, potentially justifying the postponement/avoidance of cystoscopic investigations for monitoring for recurrence patients.

The Journal of urology. 2016 Dec 13 [Epub ahead of print]

L Kavalieris, P O'Sullivan, C Frampton, P Guilford, D Darling, E Jacobson, J Suttie, J D Raman, S F Shariat, Y Lotan

Pacific Edge Ltd., Dunedin, New Zealand., Department of Medicine, University of Otago, Christchurch, New Zealand., Pacific Edge Ltd., Dunedin, New Zealand; Department of Biochemistry, University of Otago, Dunedin, New Zealand., Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA., Department of Urology, Weill Cornell Medical College, Cornell University, New York, New York, USA; Department of Urology Medical University of Vienna, Vienna, Austria; Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas, USA., Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.

Included In: Badrinath Konety, MD 2018 AUA Presentation: Journal of Urology: Top Papers in Bladder and Renal Cancer

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