Increased accuracy of a novel <scp>mRNA</scp>‐based urine test for bladder cancer surveillance

Pichler, Renate; Fritz, Josef; Tulchiner, Gennadi; Klinglmair, Gerald; Soleiman, Afschin; Horninger, Wolfgang; Klocker, Helmut; Heidegger, Isabel

doi:10.1111/bju.14019

Cited by 89 publications

(92 citation statements)

References 35 publications

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“…Combining the two tests, the overall sensitivity rose to 48.1%, and evaluating only the HG tumours, Xpert BC Monitor correctly identified 85.7% and cytology 57.1%, respectively. The significantly lower sensitivity for both tests in our study compared with Pichler et al 8 could be explained by the different analysed sample types. While we used only voided urine cytology, Pichler et al analysed voided urine and barbotage cytology but compared the performance of the test in terms of sensitivity, specificity, PPV and NPV only with bladder washing cytology.…”

Section: Discussioncontrasting

confidence: 84%

“…PPV was 36.9% for Xpert BC Monitor and 54.5% for cytology in contrast to 80% and 70%, respectively, as published by Pichler et al 8. NPV for Xpert BC Monitor was similar to cytology with 83% versus 79%, but lower in comparison with the values reported by the previous two studies (93% and 93.9%) 8 14.…”

Section: Discussionmentioning

confidence: 45%

“…Pichler et al 8 reported a high specificity for both tests: 91% for Xpert BC Monitor versus 94% for cytology (p=0.41). The specificity for the Xpert BC Monitor in our study was lower than for cytology with 76.9% versus 97.2%, respectively.…”

Section: Discussionmentioning

confidence: 97%

“…They reported an overall sensitivity of 84% for Xpert BC Monitor and 33% for bladder washing cytology 8. Van Valenberg et al conducted a multicentre study involving 22 European centres and 255 patients, reporting lower sensitivities with 75% for Xpert BC Monitor and 29.5% for cytology, respectively 14…”

Section: Discussionmentioning

confidence: 99%

“…As previously reported by Pichler et al ,8 100 tumour markers described as differentially expressed in bladder cancer were selected and tested by quantitative real-time, reverse transcription PCR (RT-PCR) to identify markers that consistently show upregulation in urine specimens from subjects with bladder cancer compared with urine specimens from control subjects. After evaluation of the 10 best biomarkers (UPK1B, IGF2, CRH, ANXA10, ABL1, KRT20, AR, PIK3CA, UPK2 and MGEA5) within a training set of 444 urine specimens, the best performing five markers were further validated.…”

Section: Introductionmentioning

confidence: 99%

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Diagnostic predictive value of Xpert Bladder Cancer Monitor in the follow-up of patients affected by non-muscle invasive bladder cancer

et al. 2018

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AimsCystoscopy and urine cytology represent the gold standard for monitoring superficial bladder cancer (BC). Xpert BC Monitor is a new urinary marker based on the evaluation of five target mRNAs overexpressed in patients with bladder cancer. The aim of our study was to evaluate the diagnostic accuracy of Xpert BC Monitor in follow-up of patients with non-muscle invasive bladder cancer (NMIBC).Methods230 patients were included in this prospective study. Xpert BC Monitor cut-off was set to 0.5. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of cytology, Xpert BC Monitor and their combination were calculated and compared with cystoscopy/histology.Results52/230 patients showed a NMIBC recurrence, 45 low grade (LG) and 7 high grade (HG). Overall sensitivity was 11.5% for cytology, 46.2% for Xpert BC Monitor and 48.1% for the two tests combined. Sensitivity of cytology increased from 4.4% in LG to 57.1% in HG tumours whereas for the Xpert BC Monitor it was 40% in LG and 85.7% in HG tumours. Combined cytology and Xpert BC Monitor yielded an overall sensitivity of 42% for LG and 85.7% for HG. Overall specificity was 97.2% for cytology, 77% for Xpert BC Monitor and 75.8% for the two tests.ConclusionsSensitivity for the Xpert BC Monitor Test was significantly higher than for cytology. The test performed very well in terms of specificity but could not reach the value of cytology, while PPV and NPV performed approximately the same for both tests.

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Section: Discussioncontrasting

confidence: 84%

Section: Discussionmentioning

confidence: 45%

Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Diagnostic predictive value of Xpert Bladder Cancer Monitor in the follow-up of patients affected by non-muscle invasive bladder cancer

et al. 2018

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Comparison of 2 new real‐time polymerase chain reaction–based urinary markers in the follow‐up of patients with non–muscle‐invasive bladder cancer

Trenti

Pycha

Mian

et al. 2020

Cancer Cytopathology

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BackgroundThe objective of the current study was to compare the diagnostic accuracy of 2 new real‐time polymerase chain reaction–based urinary markers with each other and with urinary cytology, cystoscopy, and/or histology in patients being followed for non–muscle‐invasive bladder cancer.MethodsA total of 487 patients were enrolled in the study. Patients were evaluated using voided urine cytology, the Xpert Bladder Cancer Monitor, the Bladder EpiCheck test, and white light cystoscopy.ResultsThe overall sensitivity was 27.17% for cytology, 64.13% for the Bladder EpiCheck test, and 66.3% for the Xpert Bladder Cancer Monitor. The overall specificity was 98.82% for cytology, 82.06% for the Bladder EpiCheck test, and 76.47% for the Xpert Bladder Cancer Monitor. The negative predictive value was very similar for the 3 tests at 83.56% for cytology, 89.42% for the Bladder EpiCheck test, and 89.35% for the Xpert Bladder Cancer Monitor. When combined, the Bladder EpiCheck test and Xpert Bladder Cancer Monitor detected overall 79.35% of the tumors: 70.37% in low‐grade and 92.11% in high‐grade tumors.ConclusionsThe Xpert Bladder Cancer Monitor and Bladder EpiCheck test were found to perform very well in terms of sensitivity. Together, the 2 tests detected approximately 92.11% of high‐grade tumors. Their specificity was high but could not reach the excellent value of cytology. The negative predictive value was the same for both tests and was higher than that for cytology, especially when the tests were used together (92.24%). These 2 new tests hold promise as urinary biomarkers. They may be used in combination to maximize sensitivity in a less invasive way, thereby reducing invasiveness in the follow‐up of patients with non–muscle‐invasive bladder cancer and decreasing discomfort for the patients as well as complications and costs.

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Urine cytology suspicious for urothelial carcinoma: Prospective follow‐up of cases using cytology and urine biomarker‐based ancillary techniques

Montalbo

Izquierdo

Ingelmo-Torres

et al. 2020

Cancer Cytopathology

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BackgroundUrine cytology results that are suspicious for urothelial carcinoma (UC) are challenging. The objective of this study was to elucidate the clinical significance of such results in patients who have a negative cystoscopy. MethodsIn this prospective study, 83 patients who had urine cytology that was suspicious of UC and a negative cystoscopy underwent a second cystoscopy and urine evaluation by cytology, UroVysion fluorescence in situ hybridization (FISH) assay, FGFR3 (fibroblast growth factor receptor 3) and TERT (telomerase reverse transcriptase) mutations and an 8‐gene expression classifier (GEC). Results from all techniques were compared with patients' clinical outcomes. ResultsThe presence of tumor was identified in 41% of patients; of these, 82% had tumors identified at their second evaluation (76% high‐grade [HG] tumors), and 18% had tumors identified at a later follow‐up (50% were HG tumors). After The Paris System for Reporting urinary Cytology (TPS) reclassification, 53 cytology results still had an indeterminate diagnosis (13 were suspicious for HGUC, and 40 had atypical urothelial cells (AUCs)]. Complete results from second evaluations using urine cytology, cytology‐TPS, FISH, and GEC were available for 6 cases that were suspicious for HGUC and 34 cases that had AUCs. The sensitivity of these techniques to detect HG tumors in cases that were suspicious for HGUC was 100%, except for cytology‐TPS, for which the sensitivity was 50%. The sensitivity of cytology and cytology‐TPS to detect HG tumors in cases with AUCs was 33%, whereas the sensitivity of fluorescence in situ hybridization and GEC in these cases was 83% and 75%, respectively, to detect HG tumors at the second evaluation.ConclusionsThe current results indicate the relevant clinical significance of indeterminate urine cytology findings and strongly suggest the use of complementary evaluations by urine biomarker‐based, ancillary techniques to elucidate their significance.

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Increased accuracy of a novel mRNA‐based urine test for bladder cancer surveillance

Cited by 89 publications

References 35 publications

Diagnostic predictive value of Xpert Bladder Cancer Monitor in the follow-up of patients affected by non-muscle invasive bladder cancer

Diagnostic predictive value of Xpert Bladder Cancer Monitor in the follow-up of patients affected by non-muscle invasive bladder cancer

Comparison of 2 new real‐time polymerase chain reaction–based urinary markers in the follow‐up of patients with non–muscle‐invasive bladder cancer

Urine cytology suspicious for urothelial carcinoma: Prospective follow‐up of cases using cytology and urine biomarker‐based ancillary techniques

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