Department of Urology, Caritas St. Josef Medical Center, University of Regensburg, Regensburg, Germany.
Department of Urology and Urosurgery, Medical Faculty Mannheim, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany.
BJU Int. 2024 Nov;134(5):755-762. doi: 10.1111/bju.16389. Epub 2024 May 8.
To investigate and compare the performance of urinary cytology and the Xpert BC Monitor test in the detection of bladder cancer in various clinically significant patient cohorts, including patients with carcinoma in situ (CIS), in a prospective multicentre setting, aiming to identify potential applications in clinical practice.
A total of 756 patients scheduled for transurethral resection of bladder tumour (TURBT) were prospectively screened between July 2018 and December 2020 at six German University Centres. Central urinary cytology and Xpert BC Monitor tests were performed prior to TURBT. The diagnostic performance of urinary cytology and the Xpert BC Monitor was evaluated according to sensitivity (SN), specificity (SC), negative predictive value (NPV) and positive predictive value (PPV). Statistical comparison of urinary cytology and the Xpert BC Monitor was conducted using the McNemar test.
Of 756 screened patients, 733 (568 male [78%]; median [interquartile range] age 72 [62-79] years) were included. Bladder cancer was present in 482 patients (65.8%) with 258 (53.5%) high-grade tumours. Overall SN, SC, NPV and PPV were 39%, 93%, 44% and 92% for urinary cytology, and 75%, 69%, 59% and 82% for the Xpert BC Monitor. In patients with CIS (concomitant or solitary), SN, SC, NPV and PPV were 59%, 93%, 87% and 50% for urinary cytology, and 90%, 69%, 95% and 50% for the Xpert BC Monitor. The Xpert BC Monitor missed four tumours (NPV = 98%) in patients with solitary CIS, while potentially avoiding 63.3% of TURBTs in inconclusive or negative cystoscopy and a negative Xpert result.
Positive urinary cytology may indicate bladder cancer and should be taken seriously. The Xpert BC Monitor may represent a useful diagnostic tool for correctly identifying patients with solitary CIS and unsuspicious or inconclusive cystoscopy.
在一个前瞻性多中心环境中，研究并比较尿细胞学和 Xpert BC Monitor 检测在不同具有临床意义的患者队列中检测膀胱癌的性能，包括原位癌 (CIS) 患者，以确定其在临床实践中的潜在应用。
2018 年 7 月至 2020 年 12 月，在德国 6 家大学中心前瞻性筛查了 756 例拟行经尿道膀胱肿瘤切除术 (TURBT) 的患者。在 TURBT 前进行中央尿细胞学和 Xpert BC Monitor 检测。根据敏感性 (SN)、特异性 (SC)、阴性预测值 (NPV) 和阳性预测值 (PPV) 评估尿细胞学和 Xpert BC Monitor 的诊断性能。使用 McNemar 检验对尿细胞学和 Xpert BC Monitor 进行统计学比较。
在 756 例筛查患者中，733 例（568 例男性[78%]；中位[四分位数范围]年龄 72[62-79]岁）被纳入。482 例患者（258 例高级别肿瘤[53.5%]）存在膀胱癌。尿细胞学的总体 SN、SC、NPV 和 PPV 分别为 39%、93%、44%和 92%，Xpert BC Monitor 分别为 75%、69%、59%和 82%。在 CIS（同时或单发）患者中，尿细胞学的 SN、SC、NPV 和 PPV 分别为 59%、93%、87%和 50%，Xpert BC Monitor 分别为 90%、69%、95%和 50%。Xpert BC Monitor 在 4 例（NPV=98%）单发 CIS 患者中漏诊，同时在膀胱镜检查不明确或阴性且 Xpert 结果阴性时可能避免了 63.3%的 TURBT。
阳性尿细胞学可能提示膀胱癌，应引起重视。Xpert BC Monitor 可能是一种有用的诊断工具，可正确识别单发 CIS 和膀胱镜检查不明确或阴性的患者。
