Literature DB >> 35155263

Xpert Bladder Cancer Monitor May Avoid Cystoscopies in Patients Under "Active Surveillance" for Recurrent Bladder Cancer (BIAS Project): Longitudinal Cohort Study.

Vittorio Fasulo1,2, Marco Paciotti1,2, Massimo Lazzeri2, Roberto Contieri1,2, Paolo Casale2, Alberto Saita2, Giovanni Lughezzani1,2, Pietro Diana1,2, Nicola Frego1,2, Pier Paolo Avolio1,2, Piergiuseppe Colombo1,3, Grazia Maria Elefante3, Giorgio Guazzoni1,2, Nicolò Maria Buffi1,2, Michael Bates4, Rodolfo Hurle2.   

Abstract

OBJECTIVES: To test the hypothesis that patients under active surveillance (AS) for Non-muscle Invasive Bladder Cancer (NMIBC) who were negative on longitudinal re-testing by the Xpert® Bladder Cancer Monitor (Xpert BC Monitor) assay may avoid unnecessary cystoscopies and urine cytology (UC). SUBJECTS/PATIENTS OR
MATERIALS AND METHODS: This is a prospective cohort study of patients enrolled in the AS protocol for recurrent NMIBC (Bladder Cancer Italian Active Surveillance, BIAS project), whose urine samples were analyzed by Xpert BC Monitor upon entry in the study (T0). Patients who had a negative Xpert test and did not fail AS, underwent additional Xpert tests after 4 (T1), 8 (T2), and 12 (T3) months. The clinical utility of Xpert was assessed by determining the number of cystoscopies and UC that could be avoided within 1 year.
RESULTS: Overall, 139 patients were tested with Xpert at T0. Median follow-up was 23 (IQR 17-27) months. Sixty-eight (48.9%) patients failed AS, 65 (46.7%) are currently on AS, and 6 (4.3%) were lost at follow-up. At T0 57 (41.0%) patients had a negative test and 36 (63.2%) are still in AS. In patients with 2 consecutives negative Xpert tests, we could have avoided 73.9% of unnecessary cystoscopies, missing 26.4% failure, up to avoid all cystoscopies with 4 negative tests missing only 12% of failure. All the patients with negative Xpert had negative UC. Failure-free-survival at median follow-up (23 month) stratified for having 0, 1, or ≥2 negative tests was 67.0, 55.1. and 84.1, respectively.
CONCLUSION: Our findings suggest that Xpert BC Monitor assay, when it is longitudinally repeated, could significantly reduce the number of unnecessary cystoscopies and UC during their follow-up.
Copyright © 2022 Fasulo, Paciotti, Lazzeri, Contieri, Casale, Saita, Lughezzani, Diana, Frego, Avolio, Colombo, Elefante, Guazzoni, Buffi, Bates and Hurle.

Entities:  

Keywords:  BIAS; NMIBC; Xpert BC; active surveillance; biomarker; cystoscopies; urine cytology

Year:  2022        PMID: 35155263      PMCID: PMC8830778          DOI: 10.3389/fonc.2022.832835

Source DB:  PubMed          Journal:  Front Oncol        ISSN: 2234-943X            Impact factor:   6.244


  51 in total

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2.  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.

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