Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Jan 27:12:832835.
doi: 10.3389/fonc.2022.832835. eCollection 2022.

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

Vittorio Fasulo  1   2 , Marco Paciotti  1   2 , Massimo Lazzeri  2 , Roberto Contieri  1   2 , Paolo Casale  2 , Alberto Saita  2 , Giovanni Lughezzani  1   2 , Pietro Diana  1   2 , Nicola Frego  1   2 , Pier Paolo Avolio  1   2 , Piergiuseppe Colombo  1   3 , Grazia Maria Elefante  3 , Giorgio Guazzoni  1   2 , Nicolò Maria Buffi  1   2 , Michael Bates  4 , Rodolfo Hurle  2
Affiliations

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

Vittorio Fasulo et al. Front Oncol. .

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.

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

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Flow chart of enrolled and who dropped out of the study. To access the next “time point”, each patient had to have tested negative on the Xpert Bladder Cancer Monitor test and had none of the active surveillance failure criteria.
Figure 2
Figure 2
Kaplan–Meier showing failure-free frequencies by group of patient having 0 negative test, 1 negative test or ≥2 negative tests. T1 = 4 months, T2 = 8 months, T3 = 12 months.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin (2021) 71:7–33. doi: 10.3322/caac.21654 - DOI - PubMed
    1. Carter SM, Rogers W, Heath I, Degeling C, Doust J, Barratt A. The Challenge of Overdiagnosis Begins With Its Definition. BMJ (2015) 350:h869–9. doi: 10.1136/bmj.h869 - DOI - PubMed
    1. Lowenstein LM, Basourakos SP, Williams MD, Troncoso P, Gregg JR, Thompson TC, et al. . Active Surveillance for Prostate and Thyroid Cancers: Evolution in Clinical Paradigms and Lessons Learned. Nat Rev Clin Oncol (2019) 16:168–84. doi: 10.1038/s41571-018-0116-x - DOI - PMC - PubMed
    1. Maggi M, Cowan JE, Fasulo V, Washington SL, Lonergan PE, Sciarra A, et al. . The Long-Term Risks of Metastases in Men on Active Surveillance for Early Stage Prostate Cancer. J Urol (2020) 204:1222–8. doi: 10.1097/JU.0000000000001313 - DOI - PubMed
    1. Herrera-Caceres JO, Jewett MAS. Roles for Active Surveillance in Renal Cancer. Curr Opin Urol (2018) 28:375–82. doi: 10.1097/MOU.0000000000000506 - DOI - PubMed