Bladder EpiCheck clinical utility to predict BCG response in non-muscle-invasive bladder cancer

Abstract

Objective: To evaluate the performance of Bladder Epicheck® (BE; Nucleix Ltd., Rehovot, Israel) in predicting tumour recurrence and bacillus Calmette-Guérin (BCG) failure during the first year after induction treatment.

Patients and methods: Prospective study including 65 patients with non-muscle-invasive bladder cancer treated with BCG between 2018 and 2021. Urine samples analysed with BE were collected before and after BCG induction. Logistic binary regression was used to assess the association between clinical and pathological variables and BE results with tumour recurrence and BCG failure during the first year after induction treatment.

Results: During follow-up, 16 (24.6%) patients experienced a bladder cancer event, 11 (68.8%) of which were BCG failure (high-grade recurrence) and five (31.2%) were low-grade recurrences. The median (range) time to overall recurrence was 7.3 (3.8-17.4) months. A significant association was found between the risk of tumour recurrence/BCG failure and post-BCG cystoscopy (odds ratio [OR] 10.0; P < 0.001 and OR 13.1; P < 0.001, respectively), post-BCG BE result (OR 16.9; P < 0.001 and OR 33.1; P < 0.001, respectively) and pre/post-BCG EpiScore value variation (OR 14.4; P = 0.001 and OR 7.1; P = 0.018, respectively). A nomogram including these three variables outperformed the Club Urológico Español de Tratamiento Oncológico (CUETO) risk tables to predict any bladder cancer event after BCG induction (area under the curve 95.1% vs 67.1%). Result validation in a larger and independent series is needed.

Conclusions: The BE post-BCG status and variations in EpiScore values can help us identify patients at higher risk of any bladder cancer event and BCG failure promptly. These data can have an impact on disease management.