Data from: Distinct longitudinal patterns of urine tumor DNA in patients undergoing surveillance for bladder cancer

Abstract:

Cystoscopy is the gold standard for surveillance of non-muscle invasive bladder cancer (NMIBC), but is invasive and has suboptimal accuracy. The aim of this study was to investigate the potential of urine tumor DNA (utDNA) to replace cystoscopy for surveillance of bladder cancer recurrences. In this longitudinal, prospective and observational study, 47 patients were followed for recurrence for two years, involving droplet digital PCR (ddPCR) analysis of utDNA using the BladMetrix DNA methylation biomarker test at each cystoscopy control. utDNA was detected in 21/23 recurrences (91% sensitivity), including 5/5 T1, T2 and CIS tumors (100%) and 10/12 Ta tumors (83%), with <1% false negative test results. Importantly, utDNA analysis showed potential to reduce the number of cystoscopies by 55%, benefitting 79% of the patients. Eleven of 23 recurrences (48%) were detected earlier with utDNA than with cystoscopy, and distinct patterns of residual utDNA post-surgery indicated minimal residual disease (MRD) or field effect in 6% and 15% of the patients, respectively. In conclusion, utDNA analysis shows high sensitivity to detect tumor recurrence, potential to reduce the number of cystoscopies, and promise to guide patient-specific surveillance regimes.