Diagnostic Accuracy of MCM5 for the Detection of Recurrence in Non Muscle Invasive Bladder Cancer Follow up: A Blinded, Prospective Cohort, Multicentric European Study
Articolo
Data di Pubblicazione:
2020
Citazione:
Diagnostic Accuracy of MCM5 for the Detection of Recurrence in Non Muscle Invasive Bladder Cancer Follow up: A Blinded, Prospective Cohort, Multicentric European Study / M. Roupret, P. Gontero, S.R.C. McCracken, T. Dudderidge, J. Stockley, A. Kennedy, O. Rodriguez, C. Sieverink, F. Vanié, M. Allasia, J.A. Witjes, M. Colombel, R. Sylvester, F. Longo, E. Montanari, J. Palou. - In: THE JOURNAL OF UROLOGY. - ISSN 0022-5347. - (2020). [Epub ahead of print] [10.1097/JU.0000000000001084]
Abstract:
Purpose: Detection of MCM5 containing cells in urine has been shown to be indicative for the presence of a bladder tumour in primary diagnosis. The objective of this study was to evaluate diagnostic performance of ADXBLADDER in patients undergoing cystoscopic surveillance in Non Muscle Invasive Bladder Cancer (NMIBC) follow-up.
Materials and methods: A multicentric prospective blinded study was carried out at 21 European centres in patients undergoing cystoscopy for NMIBC surveillance, diagnosed in the preceding 2 years. Urine was collected from all eligible patients and ADXBLADDER-MCM5 test was performed. Performance characteristics were calculated by comparing MCM5 results to the outcome of cystoscopy plus pathological assessment.
Results: Of 1431 eligible patients enrolled, 127 were diagnosed with a bladder cancer recurrence. The overall sensitivity for the ADXBLADDER MCM5 test in detecting bladder cancer recurrence was 44.9% (95% CI 36.1-54%) with a 75.6% sensitivity for non pTaLG tumours (95% CI 59.7-87.6%). Specificity was 71.1% (95% CI 68.5-73.5%). The overall negative predictive value was 93% (95% CI 91.2-94.5%) however ADXBLADDER was able to rule out the presence of a non-pTaLG recurrent tumour with a NPV of 99.0% (95% CI 98.2-99.5%). No statistically significant differences in the performance of ADXBLADDER were observed as a result of age or sex.
Conclusions: This large blinded prospective study demonstrates that in the follow-up of NMIBC patients ADXBLADDER is able to exclude the presence of the most aggressive tumours with a NPV of 99%. These results indicate that ADXBLADDER could be incorporated in the follow-up strategy of NMIBC.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
Biomarker; Bladder Cancer; Follow-up; MCM5; NMIBC; Surveillance; Urinary biomarker
Elenco autori:
M. Roupret, P. Gontero, S.R.C. Mccracken, T. Dudderidge, J. Stockley, A. Kennedy, O. Rodriguez, C. Sieverink, F. Vanié, M. Allasia, J.A. Witjes, M. Colombel, R. Sylvester, F. Longo, E. Montanari, J. Palou
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