Kravchuk Anton P, Wolff Ingmar, Gilfrich Christian, Wirtz Ralph M, Soares Paula, Braun Kay-Patrick, Brookman-May Sabine D, Kollitsch Lisa, Hauner Katharina, Burchardt Martin, Bründl Johannes, Burger Maximilian, May Matthias
Department of Urology, St. Elisabeth Hospital Straubing, 94315 Straubing, Germany.
Department of Urology, University Medicine Greifswald, 17475 Greifswald, Germany.
Cancers (Basel). 2024 Feb 11;16(4):753. doi: 10.3390/cancers16040753.
Optimal urine-based diagnostic tests (UBDT) minimize unnecessary follow-up cystoscopies in patients with non-muscle-invasive bladder-cancer (NMIBC), while accurately detecting high-grade bladder-cancer without false-negative results. Such UBDTs have not been comprehensively described upon a broad, validated dataset, resulting in cautious guideline recommendations. Uromonitor, a urine-based DNA-assay detecting hotspot alterations in TERT, FGFR3, and KRAS, shows promising initial results. However, a systematic review merging all available data is lacking. Studies investigating the diagnostic performance of Uromonitor in NMIBC until November 2023 were identified in PubMed, Embase, Web-of-Science, Cochrane, Scopus, and medRxiv databases. Within aggregated analyses, test performance and area under the curve/AUC were calculated. This project fully implemented the PRISMA statement. Four qualifying studies comprised a total of 1190 urinary tests (bladder-cancer prevalence: 14.9%). Based on comprehensive analyses, sensitivity, specificity, positive-predictive value/PPV, negative-predictive value/NPV, and test accuracy of Uromonitor were 80.2%, 96.9%, 82.1%, 96.6%, and 94.5%, respectively, with an AUC of 0.886 (95%-CI: 0.851-0.921). In a meta-analysis of two studies comparing test performance with urinary cytology, Uromonitor significantly outperformed urinary cytology in sensitivity, PPV, and test accuracy, while no significant differences were observed for specificity and NPV. This systematic review supports the use of Uromonitor considering its favorable diagnostic performance. In a cohort of 1000 patients with a bladder-cancer prevalence of ~15%, this UBDT would avert 825 unnecessary cystoscopies (true-negatives) while missing 30 bladder-cancer cases (false-negatives). Due to currently limited aggregated data from only four studies with heterogeneous quality, confirmatory studies are needed.
最佳尿液诊断测试（UBDT）可将非肌层浸润性膀胱癌（NMIBC）患者不必要的后续膀胱镜检查降至最低，同时准确检测出高级别膀胱癌且无假阴性结果。此类UBDT尚未在广泛且经过验证的数据集中得到全面描述，导致指南建议谨慎。Uromonitor是一种基于尿液的DNA检测方法，可检测TERT、FGFR3和KRAS的热点改变，初步结果令人鼓舞。然而，缺乏整合所有可用数据的系统评价。在PubMed、Embase、Web of Science、Cochrane、Scopus和medRxiv数据库中检索了截至2023年11月调查Uromonitor在NMIBC中诊断性能的研究。在汇总分析中，计算测试性能和曲线下面积/AUC。本项目全面实施了PRISMA声明。四项符合条件的研究共包括1190次尿液检测（膀胱癌患病率：14.9%）。基于综合分析，Uromonitor的敏感性、特异性、阳性预测值/PPV、阴性预测值/NPV和测试准确性分别为80.2%、96.9%、82.1%、96.6%和94.5%，AUC为0.886（95%可信区间：0.851 - 0.921）。在两项将测试性能与尿液细胞学进行比较的研究的荟萃分析中，Uromonitor在敏感性、PPV和测试准确性方面显著优于尿液细胞学，而在特异性和NPV方面未观察到显著差异。这项系统评价支持使用Uromonitor，因为其具有良好的诊断性能。在一个膀胱癌患病率约为15%的1000名患者队列中，这种UBDT可避免825次不必要的膀胱镜检查（真阴性），同时漏诊30例膀胱癌病例（假阴性）。由于目前仅来自四项质量参差不齐的研究的汇总数据有限，因此需要进行验证性研究。
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