D'Elia Carolina, Trenti Emanuela, Krause Philipp, Pycha Alexander, Mian Christine, Schwienbacher Christine, Hanspeter Esther, Kafka Mona, Palermo Margherita, Spedicato Giorgio Alfredo, Holl Stefanie, Pycha Armin
Department of Urology, Provincial Hospital of Bolzano, Bolzano, Italy.
Department of Urology, Bolzano Provincial Hospital, Lorenz Böhler St 5, Bolzano 39100, Italy.
Ther Adv Urol. 2022 Apr 13;14:17562872221090320. doi: 10.1177/17562872221090320. eCollection 2022 Jan-Dec.
Upper urinary tract urothelial carcinoma (UTUC) represents about 5-10% of all urothelial malignancies with an increasing incidence. The standard diagnostic tools for the detection of UTUC are cytology, computed tomography (CT) urography, and ureterorenoscopy (URS). No biomarker to be included in the daily clinical practice has yet been identified. The aim of our study was to evaluate the potential role of Xpert® Bladder-Cancer (BC)-Detection in the diagnosis of UTUC.
Eighty-two patients underwent 111 URS with Xpert® BC-Detection, cytology, or Urovysion® analysis of UT for suspicion of UTUC. Twenty-four cases were excluded from the analysis due to a non-diagnostic Xpert® BC-Detection, cytology, or Urovysion®. Samples were analyzed with upper tract (UT) urinary cytology, with Xpert® BC-Detection on UT urines, and with Urovysion® Fluorescence hybridization (FISH) test. After urine collection, the patients underwent retrograde pyelography and/or URS, and if positive a UT biopsy. The Xpert® BC-Detection was reported by the software as negative or positive [cut-off total Linear Discriminant Analysis (LDA) = 0.45]. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cytology, Xpert® BC-Detection and Urovysion-FISH were calculated using URS and/or histology results as reference.
In all, 27 (31%) of 87 URS resulted positive, with 20 low-grade (LG) and 7 high-grade (HG) tumors. Overall sensitivity was 51.9% for cytology, 100% for Xpert® BC-Detection, and 92.6% for Urovysion. The sensitivity of cytology increased from 26% in LG to 100% in HG tumors. For Xpert® BC-Detection, sensitivity was 100% both in LG and in HG, and for Urovysion-FISH, it increased from 90% in LG to 100% in HG tumors. PPV was 82.4% for cytology, 35% for Xpert® BC-Detection, and 73.5% for Urovysion. NPV was 81.4% for cytology, 100% for Xpert® BC-Detection, and 96.2% for Urovysion.
The excellent NPV of Xpert® BC-Detection allows to avoid unnecessary endoscopic exploration of the UT, reducing invasiveness and URS complications in the follow-up of UTUC.
上尿路尿路上皮癌（UTUC）约占所有尿路上皮恶性肿瘤的5%-10%，且发病率呈上升趋势。检测UTUC的标准诊断工具是细胞学检查、计算机断层扫描（CT）尿路造影和输尿管肾镜检查（URS）。目前尚未发现可纳入日常临床实践的生物标志物。本研究的目的是评估Xpert®膀胱癌（BC）检测在UTUC诊断中的潜在作用。
82例患者因怀疑UTUC接受了111次URS检查，并同时进行了Xpert® BC检测、细胞学检查或UT的Urovysion®分析。由于Xpert® BC检测、细胞学检查或Urovysion®检查结果无法诊断，24例被排除在分析之外。样本采用上尿路（UT）尿液细胞学检查、UT尿液的Xpert® BC检测以及Urovysion®荧光杂交（FISH）试验进行分析。收集尿液后，患者接受逆行肾盂造影和/或URS检查，若结果为阳性则进行UT活检。Xpert® BC检测软件报告结果为阴性或阳性[截断值总线性判别分析（LDA）=0.45]。以URS和/或组织学结果为参考，计算细胞学检查、Xpert® BC检测和Urovysion-FISH的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
87次URS检查中，共有27例（31%）结果为阳性，其中低级别（LG）肿瘤20例，高级别（HG）肿瘤7例。细胞学检查的总体敏感性为51.9%，Xpert® BC检测为100%，Urovysion为92.6%。细胞学检查的敏感性在LG肿瘤中为26%，在HG肿瘤中为100%。对于Xpert® BC检测，LG和HG肿瘤的敏感性均为100%；对于Urovysion-FISH，其在LG肿瘤中的敏感性从90%提高到HG肿瘤中的100%。细胞学检查的PPV为82.4%，Xpert® BC检测为35%，Urovysion为73.5%。细胞学检查的NPV为81.4%，Xpert® BC检测为100%，Urovysion为96.2%。
Xpert® BC检测出色的NPV可避免对UT进行不必要的内镜探查，减少UTUC随访中的侵入性和URS并发症。
