Yang Xiao, Cai Lingkai, Xin Yaqun, Chen Xinfeng, Zheng Bing, Han Jie, Yuan Lin, Yang Xuejian, Li Pengchao, Zhuang Juntao, Liu Peikun, Yu Ruixi, Bai Rongjie, Liu Yiyang, Ma Tonghui, Cao Qiang, Lu Qiang
Department of Urology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Department of Urology, Wuxi Medical Center of Nanjing Medical University, Wuxi, China.
Eur Urol Open Sci. 2025 Jun 10;77:49-57. doi: 10.1016/j.euros.2025.05.011. eCollection 2025 Jul.
The necessity of repeat transurethral resection of bladder tumor (re-TURBT) in patients with non-muscle-invasive bladder cancer (NMIBC) remains a matter of debate. The role of liquid biopsy in predicting residual tumor status and selecting patients who can be spared re-TURBT is still undefined. The aim of our study was to assess the efficacy of the urinary OncoUrine assay for mutation and methylation markers in determining the necessity for re-TURBT in NMIBC.
We prospectively recruited patients with NMIBC who were candidates for re-TURBT. Urine samples for OncoUrine testing and exfoliated cytology analysis were collected after initial TURBT, followed by re-TURBT.
Among 151 patients with NMIBC, 48 (32%) had residual tumor at re-TURBT, and 87 (58%) had detrusor muscle (DM) in their initial TURBT specimen. The OncoUrine test showed sensitivity of 77%, specificity of 78%, positive predictive value of 62%, and negative predictive value (NPV) of 88% for residual tumor, while exfoliated cytology showed corresponding values of 20%, 96%, 69%, and 72%. Stratified analyses revealed higher OncoUrine accuracy in predicting disease-free status in intermediate-risk NMIBC (NPV 98%) and in high-risk NMIBC cases with DM in the initial TURBT specimen (NPV 92%). At 18-mo follow-up for 131 patients, 20 had experienced tumor recurrence, for which OncoUrine positivity was the only independent factor predictive for the risk of recurrence (hazard ratio 3.67, 95% confidence interval 1.49-9.00; = 0.005).
The OncoUrine test may identify patients who can avoid unnecessary re-TURBT, especially for intermediate-risk NMIBC cases and high-risk NMIBC cases with DM in the initial TURBT specimen. Conversely, patients with a positive OncoUrine result are at higher risk of recurrence and should undergo re-TURBT.
OncoUrine is a urine test that can help in identifying patients with non-muscle-invasive bladder cancer who may be able to avoid unnecessary repeat resection of the bladder.
非肌层浸润性膀胱癌（NMIBC）患者重复经尿道膀胱肿瘤切除术（re-TURBT）的必要性仍存在争议。液体活检在预测残留肿瘤状态及选择可避免re-TURBT的患者方面的作用仍不明确。本研究旨在评估尿液OncoUrine检测对突变和甲基化标志物的检测在确定NMIBC患者是否需要进行re-TURBT中的有效性。
我们前瞻性招募了有re-TURBT指征的NMIBC患者。在初次TURBT后收集用于OncoUrine检测和脱落细胞学分析的尿液样本，随后进行re-TURBT。
151例NMIBC患者中，48例（32%）在re-TURBT时有残留肿瘤，87例（58%）初次TURBT标本中有逼尿肌（DM）。OncoUrine检测对残留肿瘤的敏感性为77%，特异性为78%，阳性预测值为62%，阴性预测值（NPV）为88%，而脱落细胞学的相应值分别为20%、96%、69%和72%。分层分析显示，OncoUrine在预测中危NMIBC（NPV 98%）及初次TURBT标本中有DM的高危NMIBC病例（NPV 92%）的无病状态时准确性更高。对131例患者进行18个月随访，20例出现肿瘤复发，OncoUrine检测呈阳性是复发风险的唯一独立预测因素（风险比3.67，95%置信区间1.49 - 9.00；P = 0.005）。
OncoUrine检测可识别能避免不必要re-TURBT的患者，尤其是中危NMIBC病例及初次TURBT标本中有DM的高危NMIBC病例。相反，OncoUrine检测结果为阳性的患者复发风险更高，应接受re-TURBT。
OncoUrine是一种尿液检测，可帮助识别可能避免不必要的膀胱重复切除术的非肌层浸润性膀胱癌患者。
