Bladder EpiCheck triggered Photodynamic Diagnosis biopsies Detect High-grade Bladder Cancer Recurrences Missed by White Light Cystoscopy

This is the authors' abstract. We don't add key points for this paper.

BACKGROUND AND OBJECTIVE: White light cystoscopy (WLC) misses ∼70% of carcinoma in situ bladder recurrences that could be identified via photodynamic diagnosis (PDD). The Bladder EpiCheck (BE) test has high sensitivity and specificity, with a recognised anticipatory positive signal. Our aim was to determine the diagnostic accuracy of BE and WLC against PDD-guided biopsy as the diagnostic benchmark during surveillance for high-grade (HG) non-muscle-invasive bladder cancer (NMIBC). METHODS: As part of a National Health Service (NHS) quality improvement project, all consecutive patients with HG-NMIBC who were fit for general anaesthesia and on surveillance in a tertiary centre underwent both WLC and BE from July 2023 to August 2024. Data were prospectively collected. Voided urine was collected before WLC for BE testing. Positive WLC and/or BE results triggered PDD-guided biopsy/resection under general anaesthesia. Performance metrics for WLC and BE were calculated on the basis of biopsies performed within 6 mo of a surveillance visit. KEY FINDINGS AND LIMITATIONS: Valid BE results were available for 315 HG-NMIBC surveillance visits. Of the 37 pathologically confirmed recurrences, 23 (62%, 95% confidence interval [CI] 46-76%) were detected by WLC and 34 (92%, 95% CI 79-97%) by BE (p = 0.0074). Of the 30 HG recurrences, 19 (63%, 95% CI 46-78%) were detected by WLC and 27 (90%, 95% CI 74-97%) by BE (p = 0.0386). Most of the HG cancers missed by WLC and detected by BE (73%) were Tis. Performing PDD-guided biopsies for patients with negative WLC and positive BE results increased the BE specificity from 87% (95% CI 82-90%) to 93% (95% CI 89-96%), and the positive predictive value from 35% (95% CI 24-48%) to 57% (95% CI 44-68%) at 6 mo, and to 70% (95% CI 58-80%) at longer-term follow-up. The main limitations are the nonrandomised setting and the lack of a control group. CONCLUSIONS AND CLINICAL IMPLICATIONS: BE addition to WLC, with PDD-guided biopsy performed for BE-positive cases, reveals the true performance of BE and WLC and significantly improves the detection of HG disease, allowing earlier intervention with potentially bladder-sparing options.