To investigate the clinical performance of a new mRNA-based urine test, aiming to avoid unnecessary follow-up cystoscopy in patients under active surveillance (AS) for recurrent NMIBC.
This is a prospective cohort study enrolling patients with history of low-grade (LG) NMIBC, who developed a recurrence during the follow-up and underwent AS. Their urinary samples were analyzed by Xpert BC Monitor (Cepheid, Sunnyvale, CA, USA). The primary endpoint was to investigate if Xpert BC Monitor could avoid unnecessary cystoscopy during the follow-up period. Its sensitivity, specificity, PPVs and NPVs were calculated. A cutoff of 0.4 “linear discriminant analysis” (LDA) was optimized for the AS setting.
The cohort consisted of 106 patients with a mean age of 72 ± 9.52 and a median follow-up from AS start of 8.8 (range 0–56.5) months. No statistically significant difference was found for the mean age, smoker status, lesion size, and number of lesions with a cutoff of 0.4. Of 106 patients, 22 (20.8%) were deemed to require treatment because of cystoscopic changes in size and/or number of lesions during the follow-up period. Using a cutoff value of < 0.4, 34 (33.7%) cystoscopies could be avoided due to low LDA value, missing 2/22 (9%) failures, none with high-grade (HG) NMIBC. Further research on larger population remains mandatory before its clinical use.
Xpert BC Monitor seems to be a reliable assay, which might avoid unnecessary cystoscopies without missing HG NMIBC when its cutoff is optimized for the AS setting.
This is a preview of subscription content, log in to check access.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
Tax calculation will be finalised during checkout.
Rieken M, Xylinas E, Kluth L et al (2014) Long-term cancer-specific outcomes of TaG1 urothelial carcinoma of the bladder. Eur Urol 65:201
Sylvester RJ, van der Meijden AP, Oosterlinck W et al (2006) Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol 49:466
Brausi M, Collette L, Kurth K et al (2002) Variability in the recurrence rate at first follow-up cystoscopy after TUR in stage Ta-T1 transitional cell carcinoma of the bladder: a combined analysis of seven EORTC studies. Eur Urol 41:523
Soloway MS, Bruck DS, Kim SS (2003) Expectant management of small, recurrent, noninvasive papillary bladder tumours. J Urol 170:438
Martinez Caceres P, Hidalgo Arroyo JG, Chechile Toniolo GE (2005) Is it necessary to always treat the relapses of superficial bladder tumour at the moment of diagnosis? Preliminary communication. Actas Urol Esp 29:567
Gofrit ON, Pode D, Lazar A, Katz R, Shapiro A (2006) Watchful waiting policy in recurrent Ta G1 bladder tumours. Eur Urol 49:303
Pruthi RS, Baldwin N, Bhalani V, Wallen EM (2008) Conservative management of low risk superficial bladder tumours. J Urol 179:87
Hernandez V, Alvarez M, de la Pena E (2009) Safety of active surveillance program for recurrent non muscle-invasive bladder carcinoma. Urology 73:1306
Hernández V, Llorente C, de la Peña E, Pérez-Fernández E, Guijarro A, Sola I (2016) Long-term oncological outcomes of an active surveillance program in recurrent low grade Ta bladder cancer. Urol Oncol 34(165):e19
Hurle R, Pasini L, Lazzeri M et al (2016) Active surveillance for low-risk non-muscle-invasive bladder cancer: mid-term results from the Bladder cancer Italian Active Surveillance (BIAS) project. BJU Int 118(6):935
Hurle R, Lazzeri M, Vanni E et al (2018) Active surveillance for low risk nonmuscle invasive bladder cancer: a confirmatory and resource consumption study from the BIAS project. J Urol 199:401
Strock V, Holmang S (2013) A prospective Study of size, number and histopathology of new and recurrent bladder tumours. Urol Pract 2:260
Hurle R, Colombo P, Lazzeri M et al (2018) Pathological outcomes for patients who failed to remain under active surveillance for low-risk non-muscle-invasive bladder cancer: update and results from the bladder cancer: update and results from the bladder cancer Italian active surveillance project. Eur Urol Oncol. https://doi.org/10.1016/j.euo.2018.05.006(in press)
Wallace E, Higuchi R, Satya M et al (2018) Development of a 90-minute integrated noninvasive urinary assay for bladder cancer detection. J Urol 199(3):65
Pichler R, Fritz J, Tulchiner G et al (2018) Increased accuracy of a novel mRNA-based urine test for bladder cancer surveillance. BJU Int 121:29
Angulo JC, Lopez JI, Grignon DJ, Sanchez-Chapado M (1995) Muscularis mucosa differentiates two populations with different prognosis in stage T1 bladder cancer. Urology 45:47
Barkan GA, Wojcik EM, Nayar R et al (2016) The Paris system for reporting urinary cytology: the quest to develop a standardized terminology. Adv Anat Pathol 23:193
Crundwell M (2004) Pathology and genetics of tumours of the urinary system and male genital organs. International Agency for Research on Cancer (IARC), Oxford University Press
Edge S, Byrd DR, Compton CC, Fritz AG, Greene F, Trotti A (eds) (2009) AJCC cancer staging handbook, 7th edn. Springer, New York
D’Elia C, Pycha A, Folchini DM et al (2019) Diagnostic predictive value of Xpert Bladder Cancer Monitor in the follow-up of patients affected by non-muscle invasive bladder cancer. J Clin Pathol 72(2):140
van Valenberg FJPV, Hiar AM, Wallace E et al (2018) Prospective validation of an mRNA-based urine test for surveillance of patients with bladder cancer. Eur Urol. https://doi.org/10.1016/j.eururo.2018.11.055(in press)
Babjuk M, Bohle A, Burger M et al (2017) EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2016. Eur Urol 71:447
Burger M, Grossman HB, Droller M et al (2013) Photodynamic diagnosis of non-muscle-invasive bladder cancer with hexaminolevulinate cystoscopy: a meta-analysis of detection and recurrence based on raw data. Eur Urol 64:846–854
Yafi FA, Brimo F, Steinberg J, Aprikian AG, Tanguay S, Kassouf W (2015) Prospective analysis of sensitivity and specificity of urinary cytology and other urinary biomarkers for bladder cancer. Urol Oncol 33:66
McCroskey Z, Pambuccian SE, Kleitherms S et al (2015) Accuracy and interobserver variability of the cytologic diagnosis of low-grade urothelial carcinoma in instrumented urinary tract cytology specimens. Am J Clin Pathol 144:902
We would like to thank Nadia Lo Iacono, who provided and supervised the data management.
Conflict of interest
The authors declare that they have no conflict of interest and do not have anything to disclose.
The study was approved by the institutional research committee and was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
About this article
Cite this article
Hurle, R., Casale, P., Saita, A. et al. Clinical performance of Xpert Bladder Cancer (BC) Monitor, a mRNA-based urine test, in active surveillance (AS) patients with recurrent non-muscle-invasive bladder cancer (NMIBC): results from the Bladder Cancer Italian Active Surveillance (BIAS) project. World J Urol 38, 2215–2220 (2020). https://doi.org/10.1007/s00345-019-03002-3
- Active surveillance
- mRNA-based urine test
- Non-muscle-invasive bladder cancer