Roldán Fiorella L, Ingelmo-Torres Mercedes, Mercader Claudia, Figueras Marcel, Padullés Bernat, Durán María Angeles, Carrasco Josep L, Ribal María José, Franco Agustín, Izquierdo Laura, Alcaraz Antonio, Mengual Lourdes
Laboratori i Servei d'Urologia, Hospital Clinic de Barcelona, Barcelona, Spain.
Genètica i Tumors Urològics, Fundació de Recerca Clinic Barcelona-Institut d'Investigacions Biomèdiques August Pi i Sunyer (FRCB-IDIBAPS), Barcelona, Spain.
BJU Int. 2025 Oct;136(4):682-689. doi: 10.1111/bju.16697. Epub 2025 Mar 6.
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.
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.
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.
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.
评估膀胱上皮检测试剂盒（Bladder Epicheck®，BE；以色列雷霍沃特市Nucleix有限公司）在诱导治疗后第一年预测肿瘤复发和卡介苗（BCG）治疗失败的性能。
一项前瞻性研究，纳入了2018年至2021年间65例接受卡介苗治疗的非肌层浸润性膀胱癌患者。在卡介苗诱导治疗前后收集用BE分析的尿液样本。采用逻辑二元回归分析评估临床和病理变量以及BE结果与诱导治疗后第一年肿瘤复发和卡介苗治疗失败之间的关联。
在随访期间，16例（24.6%）患者发生了膀胱癌事件，其中11例（68.8%）为卡介苗治疗失败（高级别复发），5例（31.2%）为低级别复发。总体复发的中位（范围）时间为7.3（3.8 - 17.4）个月。发现肿瘤复发/卡介苗治疗失败风险与卡介苗治疗后膀胱镜检查结果（优势比[OR]分别为10.0；P < 0.001和OR为13.1；P < 0.001）、卡介苗治疗后BE结果（OR分别为16.9；P < 0.001和OR为33.1；P < 0.001）以及卡介苗治疗前后EpiScore值变化（OR分别为14.4；P = 0.001和OR为7.1；P = 0.018）之间存在显著关联。包含这三个变量的列线图在预测卡介苗诱导治疗后任何膀胱癌事件方面优于西班牙泌尿肿瘤治疗俱乐部（CUETO）风险表（曲线下面积分别为95.1%和67.1%）。需要在更大的独立队列中进行结果验证。
卡介苗治疗后的BE状态和EpiScore值变化有助于我们迅速识别发生任何膀胱癌事件和卡介苗治疗失败风险较高的患者。这些数据可能会对疾病管理产生影响。
