<abstract xmlns="http://www.w3.org/1999/xhtml"><sec id="j_raon-2020-0072_s_006_w2aab3b7b9b1b6b1aab1c16b1Aa"><h3>Background</h3><p>Cystoscopy in complement with urinary cytology represents the gold standard for the follow-up of patients with urinary bladder tumours. Xpert Bladder Cancer Monitor Test (XBC) is a novel mRNA-based urine test for bladder cancer surveillance. The aim of the study was to evaluate the performance of the XBC and voided urinary cytology (VUC) in the follow-up of bladder tumours.</p></sec><sec id="j_raon-2020-0072_s_007_w2aab3b7b9b1b6b1aab1c16b2Aa"><h3>Patients and methods</h3><p>The XBC was performed on stabilized voided urine and VUC was performed on urine samples. The results were compared to cystoscopic findings and histopathological results after transurethral resection of the bladder lesion.</p></sec><sec id="j_raon-2020-0072_s_008_w2aab3b7b9b1b6b1aab1c16b3Aa"><h3>Results</h3><p>For the prediction of malignant histopathological result sensitivity, the specificity and negative predictive value were 76.9%, 9 7.5% and 93.0% for the XBC and 38.4%, 9 7.5% and 83.3%, respectively for VUC. For the prediction of suspicious or positive cystoscopic finding sensitivity, the specificity and negative predictive value were 75.0%, 95.2%, and 93.0% respectively for the XBC and 41.7%, 97.6%, and 85.4% for VUC. The sensitivities for papilary urothelial neoplasms of low malignant potential (PUNLMP), low- and high-grade tumours were 0.0%, 66.7% an d 100.0% for the XBC and 0.0%, 66 .7% and 42.9%, respectively for VUC.</p></sec><sec id="j_raon-2020-0072_s_009_w2aab3b7b9b1b6b1aab1c16b4Aa"><h3>Conclusions</h3><p>The XBC showed significantly higher overall sensitivity and negative predictive value than VUC and could be used to increase the recommended follow-up cystoscopy time intervals. Complementing the XBC and voided urinary cytology does not improve performance in comparison to the XBC alone.</p></sec></abstract>

BackgroundCystoscopy in complement with urinary cytology represents the gold standard for the follow-up of patients with urinary bladder tumours. Xpert Bladder Cancer Monitor Test (XBC) is a novel mRNA-based urine test for bladder cancer surveillance. The aim of the study was to evaluate the performance of the XBC and voided urinary cytology (VUC) in the follow-up of bladder tumours.Patients and methodsThe XBC was performed on stabilized voided urine and VUC was performed on urine samples. The results were compared to cystoscopic findings and histopathological results after transurethral resection of the bladder lesion.ResultsFor the prediction of malignant histopathological result sensitivity, the specificity and negative predictive value were 76.9%, 9 7.5% and 93.0% for the XBC and 38.4%, 9 7.5% and 83.3%, respectively for VUC. For the prediction of suspicious or positive cystoscopic finding sensitivity, the specificity and negative predictive value were 75.0%, 95.2%, and 93.0% respectively for the XBC and 41.7%, 97.6%, and 85.4% for VUC. The sensitivities for papilary urothelial neoplasms of low malignant potential (PUNLMP), low- and high-grade tumours were 0.0%, 66.7% an d 100.0% for the XBC and 0.0%, 66 .7% and 42.9%, respectively for VUC.ConclusionsThe XBC showed significantly higher overall sensitivity and negative predictive value than VUC and could be used to increase the recommended follow-up cystoscopy time intervals. Complementing the XBC and voided urinary cytology does not improve performance in comparison to the XBC alone.

The performance of the Xpert Bladder Cancer Monitor Test and voided urinary cytology in the follow-up of urinary bladder tumors

Radiology and Oncology

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

BackgroundCystoscopy in complement with urinary cytology represents the gold standard for the follow-up of patients with urinary bladder tumours. Xpert Bladder...

Test / Stage	CIS	Ta	T1	T2	Grade	PUNLMP	low grade	high grade
XBC, LDATC 0.4923	100%(2/2)	80.0%(4/5)	100%(2/2)	100%(1/1)		0.0%(0/1)	66.7%(2/3)	100.0%(7/7)
VUC	50.0%(1/2)	40.0%(2/5)	50.0%(1/2)	100%(1/1)		0.0%(0/1)	66.7%(2/3)	42.9%(3/7)

Gender	Number of patients	Mean age, years ± SD
All	54 (100.0%)	70.5 ± 8.8
Male	42 (77.8%)	70.5 ± 8.7
Female	12 (22.2%)	70.5 ± 9.6

Noninvasive test / standard invasive diagnostic procedure	Number of patients with TP / FN / TN / FP noninvasive test result

XBC / cystocopy (LDATC 0.4923)	9 / 3 / 40 / 2
XBC / cystocopy (LDATC 0.5)	8 / 4 / 40 / 2
VUC / cystoscopy	5 / 7 / 41 / 1
XBC / histology (LDATC 0.4923)	10 / 3 / 40 / 1
XBC / histology (LDATC 0.5)	9 / 4 / 40 / 1
VUC / histology	5 / 8 / 40 / 1

Test	Sensitivity	Specificity	PPV	NPV
XBC, LDATC 0.4923	76.9%	97.5%	90,9%	93.0%
XBC, LDATC 0.5	69.2%	97.5%	90.0%	90.9%
VUC	38.4%	97.5%	83.3%	83.3%
XBC, LDATC 0.4923 + VUC	76.9%	97.5%	90,9%	93.0%

The performance of the Xpert Bladder Cancer Monitor Test and voided urinary cytology in the follow-up of urinary bladder tumors

Article Category: Research Article

Data publikacji: 29 gru 2020

Zakres stron: 196 - 202

Otrzymano: 22 wrz 2020

Przyjęty: 03 lis 2020

DOI: https://doi.org/10.2478/raon-2020-0072

© 2021 Tomaz Smrkolj, Urska Cegovnik Primozic, Teja Fabjan, Sasa Sterpin, Josko Osredkar, published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License.

Figure 1

Figure 2

Specificity, sensitivity and positive and negative predictive value of noninvasive urinary tests for the prediction of positive cystoscopic findings

Sensitivity of the XBC and voided urinary cytology stratified by tumour stage and grade. Number of cases detected by noninvasive test against number of cases detected by hystology analysis is shown in the parenthsis

Summary of the patients’ demographics and test results numbers

Specificity, sensitivity and positive and negative predictive value of noninvasive urinary tests for the prediction of positive histological results

Test	Sensitivity	Specificity	PPV	NPV
XBC, LDATC 0.4923	75.0%	95.2%	81,8%	93.0%
XBC, LDATC 0.5	66.7%	95.2%	80.0%	90.9%
VUC	41.7%	97.6%	83.3%	85.4%
XBC, LDATC 0.4923 + VUC	75.0%	95.2%	81,8%	93.0%