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

Frontiers in Oncology

Piergiuseppe Colombo²  Grazia Maria Elefante²  Pietro Diana³  Giovanni Lughezzani³  Vittorio Fasulo³  Giorgio Guazzoni³  Alberto Saita³  Paolo Casale³  Marco Paciotti³  Roberto Contieri³  Rodolfo Hurle³  Nicolò Maria Buffi³  Massimo Lazzeri³  Pier Paolo Avolio³  Nicola Frego³  Michael Bates⁴ 

[1] Department of Biomedical Sciences, Humanitas University, Milan, Italy;Department of Pathology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Humanitas Research Hospital, Milan, Italy;Department of Urology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Humanitas Research Hospital, Milan, Italy;Medical and Scientific Affairs and Strategy, Oncology, Cepheid, Sunnyvale, CA, United States;

关键词: BIAS;    active surveillance;    Xpert BC;    NMIBC;    biomarker;    cystoscopies;   

DOI  :  10.3389/fonc.2022.832835

来源: DOAJ

【 摘 要 】

ObjectivesTo 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 MethodsThis 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.ResultsOverall, 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.ConclusionOur 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.

【 授权许可】

Unknown