Sorbonne Université, GRC n°5, Predictive Onco-Urology, AP-HP, Hôpital Tenon, Service d'Urologie-Batiment Gabriel, 4 rue de la Chine, 75020, Paris, France.
CeRePP, Hôpital Tenon, 75020, Paris, France.
World J Urol. 2021 Sep;39(9):3329-3335. doi: 10.1007/s00345-021-03629-1. Epub 2021 Mar 26.
To assess the performance of the Xpert Bladder Cancer (BC) Monitor during the follow-up of patients with non-muscle invasive bladder cancer (NMIBC).
Patients with previously diagnosed NMIBC and followed up in clinical practice settings in two French urology departments between September 2017 and July 2019 were consecutively enrolled in this prospective observational study. Patients with a positive cystoscopy or computed tomography urogram underwent subsequent transurethral resection of the bladder, and/or biopsy, and the specimens were pathologically assessed. Cytology and Xpert BC Monitor tests were performed on urine samples. Xpert BC Monitor performance was assessed versus cystoscopy for disease-negative patients or versus histology for disease-positive patients, and was compared to that of cytology.
Overall, 500 patients with a median age of 70.0 years were included. NMIBC recurrence was diagnosed in 44 cases (8.8%). Overall sensitivity, specificity, and negative predictive values (NPVs) were 72.7% (32/44), 73.7% (330/448) and 96.5% (330/342) for the Xpert BC Monitor, and 7.7% (2/26), 97.8% (310/317) and 92.8% (310/334) for cytology, respectively. The Xpert BC Monitor detected 92.3% (12/13) of the high-grade tumours and ruled out their presence in 99.7% (330/331) of cases. Analysis of the areas under the receiver operating characteristic curves demonstrated the superior performance of the Xpert BC Monitor over that of cytology.
Xpert BC Monitor performance was superior to that of cytology in the follow-up of NMIBC. The exclusion of aggressive tumours with a very high NPV (99.7%) supports the use of this urinary test in daily practice.
评估 Xpert 膀胱癌（BC）监测仪在非肌肉浸润性膀胱癌（NMIBC）患者随访中的表现。
本前瞻性观察性研究纳入了 2017 年 9 月至 2019 年 7 月在法国两家泌尿科的临床实践环境中确诊为 NMIBC 并接受随访的患者。对膀胱镜检查或计算机断层尿路造影术阳性的患者进行经尿道膀胱肿瘤切除术和/或活检，对标本进行病理评估。对尿液样本进行细胞学和 Xpert BC 监测仪检测。Xpert BC 监测仪的性能针对疾病阴性患者与膀胱镜检查进行评估，针对疾病阳性患者与组织学检查进行评估，并与细胞学进行比较。
共纳入 500 例中位年龄为 70.0 岁的患者。NMIBC 复发诊断 44 例（8.8%）。Xpert BC 监测仪的总体敏感性、特异性和阴性预测值（NPV）分别为 72.7%（32/44）、73.7%（330/448）和 96.5%（330/342），细胞学分别为 7.7%（2/26）、97.8%（310/317）和 92.8%（310/334）。Xpert BC 监测仪检测到 92.3%（12/13）的高级别肿瘤，在 99.7%（330/331）的病例中排除了其存在。受试者工作特征曲线下面积分析表明，Xpert BC 监测仪的性能优于细胞学。
在 NMIBC 的随访中，Xpert BC 监测仪的性能优于细胞学。极高的 NPV（99.7%）排除了侵袭性肿瘤的存在，支持该尿液检测在日常实践中的应用。
