Abstract
Simple SummaryPatients with bladder cancer (BC) require close follow-up with white-light cystoscopy (WLC) and cytology. In this study, we sought to assess (a) the performance of a novel cystoscopy technology based on Narrow Band Imaging© (NBI), and (b) a new urine test (XPERT© Bladder Cancer Monitor, XBCM) that detects cancer proteins. We compared these to the established standard follow-up diagnostics. Our study showed that NBI cystoscopy does not provide any additional benefit over standard WLC. However, the XBCM urine test performed particularly well in instances of aggressive high-grade tumor recurrence. Therefore, XBCM may have enhanced utility in the early detection of potentially harmful BC recurrence.Follow-up is essential for the early detection of recurrent non-muscle invasive bladder cancers (NMIBC). This study investigates the clinical relevance of new diagnostic tools such as an mRNA-based urine test (XPERT© Bladder Cancer Monitor, XBCM) and Narrow Band Imaging© (NBI) and compares them with the established follow-up diagnostics (white-light cystoscopy (WLC) and urine cytology). This was a prospective, double-blind, single-center study that involved patients undergoing NMIBC screening at a tertiary care center. Enrollment occurred between January 2018 and March 2020. In addition to standard care (WLC, cytology, and ultrasound), patients underwent XBCM urine testing and NBI cystoscopy. In total, 301 WLCs were performed; through this, 49 patients demonstrated NMIBC recurrence. NBI cystoscopy was congruent with WLC in all patients. Cytology showed a sensitivity (SE) and specificity (SP) of 27% and 97% (PPV: 65%; NPV 87%), respectively, whereas XBCM showed SE and SP of 58% and 89%, respectively (PPV: 51%; NPV: 92%; AUC: 0.79 (0.716–0.871)). Subgroup analysis showed improved SE and similar SP (PPV, NPV) for high grade (HG) recurrence, with a SE of 74% and SP of 89% (39%, 97%). NBI cystoscopy does not necessarily provide additional benefit over standard WLC. However, the XBCM may provide better SE and a diagnostic advantage in instances of HG disease recurrence.
Highlights
Urothelial carcinoma of the bladder (BC) is one of the most common cancers worldwide
We report the findings of our prospective single-center study aimed at (a) evaluating the clinical performance characteristics of XPERT Bladder Cancer Monitor© (XBCM) and NBI compared to white-light cystoscopy (WLC), urine cytology, and histopathology via transurethral resection of bladder tumors (TURBT), and (b) using the linear discriminant analysis (LDA) of XBCM to identify different thresholds to potentially improve upon the SE of the test
Of the 301 WLCs, 116 (38.5%) initially had low-grade disease while 153 (50.8%) demonstrated high-grade urothelial carcinoma. 31 patients (10.2%) had an unknown BC status (Table 1). 11 patients presented with hematuria at initial follow-up, 93 did not, and 32 had an unknown or undocumented hematuria status. 53 patients were current or former smokers, 23 were nonsmokers, and 60 had an unknown or undocumented smoking status. 20 patients were initially diagnosed with pT1 disease, 111 with pTa, and 5 with pTis
Summary
Urothelial carcinoma of the bladder (BC) is one of the most common cancers worldwide. Cigarette smoking is the most important risk factor for the disease [1,2]. 75% of BC patients have non-muscle invasive tumors (NMIBC), while the remaining 25% are muscle invasive (MIBC). Untreated MIBC has a higher cancer-specific mortality (CSM; 41%) after five years compared to NMIBC patients (7%) [2,3]. Despite the lower CSM, NMIBC has a higher probability of disease recurrence (approximately 70%) within 5 years. It is likely that the majority of patients diagnosed with BC have NMIBC that will progress to MIBC if left untreated, and this mandates frequent and reliable follow-up (FU) [4]
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