Renate Pichler1, Josef Fritz2, Gennadi Tulchiner1, Gerald Klinglmair1, Afschin Soleiman3, Wolfgang Horninger1, Helmut Klocker1,4, Isabel Heidegger1. 1. Department of Urology, Medical University Innsbruck, Innsbruck, Austria. 2. Department of Medical Statistics, Informatics and Health Economics, Medical University Innsbruck, Innsbruck, Austria. 3. Clinical Pathology and Cytodiagnostics, Tyrolean State Hospitals Ltd, Innsbruck, Austria. 4. Urological Laboratory and Division of Experimental Urology, Innsbruck, Austria.
Abstract
OBJECTIVES: To evaluate the diagnostic accuracy of the Xpert Bladder Cancer (BC) Monitor, compared with cystoscopy and cytology in the oncological follow-up of non-muscle-invasive bladder cancer (NMIBC). MATERIAL AND METHODS: A total of 140 patients with a history of NMIBC undergoing routine surveillance at our institution were enrolled prospectively in this study (ISRCTN study registry number 37210907). Urine cytology was evaluated according to the Paris classification system. In addition, urinary specimens were analysed using the Xpert BC Monitor, which measures five target mRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) using real-time PCR. Descriptive analysis, diagnostic accuracy including sensitivity, specificity, positive (PPV) and negative predictive value (NPV), receiver-operating characteristic curve, and area under the curve (AUC) were calculated. RESULTS: The overall sensitivity (0.84) and NPV (0.93) of the Xpert BC Monitor were significantly superior to those of bladder washing cytology (0.33 and 0.76; P < 0.001). Subgroup analyses confirmed the high sensitivity of the Xpert BC Monitor even in low-grade (0.77) and pTa (0.82) disease compared with barbotage cytology (low-grade: 0.13; pTa: 0.21). The overall specificity of the Xpert BC Monitor and barbotage cytology was similar (0.91 vs 0.94; P = 0.41). Combining the Xpert BC Monitor with barbotage cytology (AUC = 0.85) did not enhance diagnostic performance compared with the performance of the Xpert BC Monitor alone (AUC = 0.87). CONCLUSION: In this study, we report for the first time that the Xpert BC Monitor, a new mRNA-based urine test, outperforms cytology with regard to sensitivity and NPV, even in low-grade and pTa tumours, with no reduction of specificity.
OBJECTIVES: To evaluate the diagnostic accuracy of the Xpert Bladder Cancer (BC) Monitor, compared with cystoscopy and cytology in the oncological follow-up of non-muscle-invasive bladder cancer (NMIBC). MATERIAL AND METHODS: A total of 140 patients with a history of NMIBC undergoing routine surveillance at our institution were enrolled prospectively in this study (ISRCTN study registry number 37210907). Urine cytology was evaluated according to the Paris classification system. In addition, urinary specimens were analysed using the Xpert BC Monitor, which measures five target mRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) using real-time PCR. Descriptive analysis, diagnostic accuracy including sensitivity, specificity, positive (PPV) and negative predictive value (NPV), receiver-operating characteristic curve, and area under the curve (AUC) were calculated. RESULTS: The overall sensitivity (0.84) and NPV (0.93) of the Xpert BC Monitor were significantly superior to those of bladder washing cytology (0.33 and 0.76; P < 0.001). Subgroup analyses confirmed the high sensitivity of the Xpert BC Monitor even in low-grade (0.77) and pTa (0.82) disease compared with barbotage cytology (low-grade: 0.13; pTa: 0.21). The overall specificity of the Xpert BC Monitor and barbotage cytology was similar (0.91 vs 0.94; P = 0.41). Combining the Xpert BC Monitor with barbotage cytology (AUC = 0.85) did not enhance diagnostic performance compared with the performance of the Xpert BC Monitor alone (AUC = 0.87). CONCLUSION: In this study, we report for the first time that the Xpert BC Monitor, a new mRNA-based urine test, outperforms cytology with regard to sensitivity and NPV, even in low-grade and pTa tumours, with no reduction of specificity.
Authors: Vittorio Fasulo; Marco Paciotti; Massimo Lazzeri; Roberto Contieri; Paolo Casale; Alberto Saita; Giovanni Lughezzani; Pietro Diana; Nicola Frego; Pier Paolo Avolio; Piergiuseppe Colombo; Grazia Maria Elefante; Giorgio Guazzoni; Nicolò Maria Buffi; Michael Bates; Rodolfo Hurle Journal: Front Oncol Date: 2022-01-27 Impact factor: 6.244
Authors: Barrett Cowan; Eric Klein; Ken Jansz; Karl Westenfelder; Timothy Bradford; Chad Peterson; Douglas Scherr; Lawrence I Karsh; Blair Egerdie; Alfred Witjes; Andrew Trainer; Richard Harris; Bernard Goldfarb; Stanley Flax; Robert Kroeger; Buffi Boyd; Joseph Liao; Sanjay Patel; Julia Bridge; Victor Reuter; Neil Quigley; Sarah Brown; Suling Zhao; Malini Satya; Michael Bates; Iris M Simon; Scott Campbell; Yair Lotan Journal: BJU Int Date: 2021-05-05 Impact factor: 5.969