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

Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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.

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Acknowledgment

We would like to thank Nadia Lo Iacono, who provided and supervised the data management.

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Authors

Contributions

RH: project development, data collection. PC: data management and supervision. AS: data management. PC: data collection. GME: data collection. GL: data management. VF: data collection, manuscript editing. MP: data collection. LD: data collection. GB: data collection. DM: data collection. PD: data collection. NF: data collection. MTS: data collection. FM: data collection. EM: data analysis. NMB: data management. GG: supervision. ML: project development, manuscript writing, data analysis, data collection.

Corresponding author

Correspondence to Massimo Lazzeri.

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The authors declare that they have no conflict of interest and do not have anything to disclose.

Ethical approval

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.

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Informed consent was obtained from all individual participants included in the study.

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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

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Keywords

  • Active surveillance
  • Cystoscopy
  • mRNA-based urine test
  • Non-muscle-invasive bladder cancer