Clinical genitourinary cancer · 2025
mRNA-Based Urine Test Performance in High and Very-High Risk Non-Muscle-Invasive Bladder Cancer Patients Undergoing Contextual Endoscopic Follow-up (VERNAL: Vesical Tumor Early Monitoring: mRNA-Based Follow-up).
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Macchi Alberto, Bruniera Martina, Nazzani Sebastiano, Ceccato Tommaso, Colbacchini Claudia, Taverna Alessandra, Aiello Giuseppe, Bernasconi Valentina, Catanzaro Mario, Torelli Tullio, Biasoni Davide, Stagni Silvia, Tesone Antonio, Silvani Carlo, Claps Melanie, Giannatempo Patrizia, Zimatore Matteo, Bonini Chiara, Morelli Daniele, Nicolai Nicola
Аннотация
INTRODUCTION AND OBJECTIVES: Non-muscle-invasive bladder cancer (NMIBC) patients need a strict follow-up with cystoscopy (UCS) and voided urinary cytology (vUC) due to high rate of recurrence and progression. To reduce invasiveness and costs, a new diagnostic biomarker, namely Xpert Monitor BCⓇ-detecting 5 mRNAs in voided urine-, has been proposed. We test Xpert Monitor BCⓇ ability to detect tumor recurrence at an early point during follow-up of high risk (HR) or very high risk (VHR) NMIBC patients, aiming at evaluating reliability of this test as a single procedure.
MATERIALS AND METHODS: Between September 2022 and July 2023 included, 80 HR or VHR NMIBC patients were prospectively enrolled. Both naïve and previously treated patients (including Bacillus Calmette-Guérin-BCG-and/or systemic immunotherapy) were admitted. Patients with known upper urinary tract urothelial carcinoma (UTUC) were excluded. Xpert Monitor BCⓇ test was carried out on precystoscopy voided urine samples. In case of suspicious urethra-cystoscopy (UCS), a transurethral resection (TURB) or a biopsy was indicated. vUC was usually prescribed to be performed prior to UCS. Negative predictive value (NVP), positive predictive value (PPV), sensitivity (SE) and specificity (SP) of Xpert Monitor BCⓇ and vUC, were assessed and compared with UCS and secondarily with histology at TURB/bladder biopsy. Patients who proceeded with follow-up underwent a second evaluation with Xpert Monitor BCⓇ test.
RESULTS: Seventy-six patients were evaluable. Median age was 70 years (interquartile range [IQR] 65-78) and 62 (81.6%) patients were male. VHR patients were 14 (18.4%), 47 (61.8%) had a history of carcinoma in situ (CIS) and 37 (49.3%) had multifocal disease while 51 patients (67.1%) had recurrent bladder cancer (BC). BC recurred in 15 patients (19.7%): in 3 of them as a muscle-invasive bladder cancer (MIBC). Xpert Monitor BCⓇ showed a NPV, PPV, SE, SP of 95.3% (41/43), 57.6% (19/33), 90.5% (19/21) and 74.5% (41/55) respectively. When available, vUC displayed a NPV of 78.9% (30/38), a PPV of 75% (3/4), a SE of 27.3% (3/11) and a SP of 96.7% (30/31). Twenty patients underwent a subsequent Xpert Monitor BCⓇ test and UCS during their follow-up, and 3 had a bladder cancer recurrence. Of note Xpert Monitor BCⓇ was positive in all those 3 patients who previously tested positive despite a negative UC.
CONCLUSIONS: High NPV and SE of Xpert Monitor BCⓇ are confirmed in our HR and VHR NMIBC series. Apparent false positive tests may be regarded as suspicious for persistent/recurrent disease. Implementation of Xpert Monitor BCⓇ aiming at improving cancer detection is supported by these findings, and a single test based follow-up may be explored.
MATERIALS AND METHODS: Between September 2022 and July 2023 included, 80 HR or VHR NMIBC patients were prospectively enrolled. Both naïve and previously treated patients (including Bacillus Calmette-Guérin-BCG-and/or systemic immunotherapy) were admitted. Patients with known upper urinary tract urothelial carcinoma (UTUC) were excluded. Xpert Monitor BCⓇ test was carried out on precystoscopy voided urine samples. In case of suspicious urethra-cystoscopy (UCS), a transurethral resection (TURB) or a biopsy was indicated. vUC was usually prescribed to be performed prior to UCS. Negative predictive value (NVP), positive predictive value (PPV), sensitivity (SE) and specificity (SP) of Xpert Monitor BCⓇ and vUC, were assessed and compared with UCS and secondarily with histology at TURB/bladder biopsy. Patients who proceeded with follow-up underwent a second evaluation with Xpert Monitor BCⓇ test.
RESULTS: Seventy-six patients were evaluable. Median age was 70 years (interquartile range [IQR] 65-78) and 62 (81.6%) patients were male. VHR patients were 14 (18.4%), 47 (61.8%) had a history of carcinoma in situ (CIS) and 37 (49.3%) had multifocal disease while 51 patients (67.1%) had recurrent bladder cancer (BC). BC recurred in 15 patients (19.7%): in 3 of them as a muscle-invasive bladder cancer (MIBC). Xpert Monitor BCⓇ showed a NPV, PPV, SE, SP of 95.3% (41/43), 57.6% (19/33), 90.5% (19/21) and 74.5% (41/55) respectively. When available, vUC displayed a NPV of 78.9% (30/38), a PPV of 75% (3/4), a SE of 27.3% (3/11) and a SP of 96.7% (30/31). Twenty patients underwent a subsequent Xpert Monitor BCⓇ test and UCS during their follow-up, and 3 had a bladder cancer recurrence. Of note Xpert Monitor BCⓇ was positive in all those 3 patients who previously tested positive despite a negative UC.
CONCLUSIONS: High NPV and SE of Xpert Monitor BCⓇ are confirmed in our HR and VHR NMIBC series. Apparent false positive tests may be regarded as suspicious for persistent/recurrent disease. Implementation of Xpert Monitor BCⓇ aiming at improving cancer detection is supported by these findings, and a single test based follow-up may be explored.