Soorojebally Yanish, Neuzillet Yann, Roumiguié Mathieu, Lamy Pierre-Jean, Allory Yves, Descotes Françoise, Ferlicot Sophie, Kassab-Chahmi Diana, Oudard Stéphane, Rébillard Xavier, Roy Catherine, Lebret Thierry, Rouprêt Morgan, Audenet François
Department of Urology, Foch Hospital, Paris Saclay University, Suresnes, France.
Department of Urology, Andrology and Renal Transplantation, CHU Rangueil, Paul-Sabatier University, Toulouse Cedex, France.
World J Urol. 2023 Feb;41(2):345-359. doi: 10.1007/s00345-022-04253-3. Epub 2023 Jan 2.
Bladder cancer detection and follow-up is based on cystoscopy and/or cytology, but it remains imperfect and invasive. Current research focuses on diagnostic biomarkers that could improve bladder cancer detection and follow-up by discriminating patients at risk of aggressive cancer who need confirmatory TURBT (Transurethral Resection of Bladder Tumour) from patients at no risk of aggressive cancer who could be spared from useless explorations.
To perform a systematic review of data on the clinical validity and clinical utility of eleven urinary biomarkers (VisioCyt, XpertBladder, BTA stat, BTA TRAK™, NMP22 BC, NMP22 BladderChek Test, ImmunoCyt™/uCyt1+™, UroVysion Bladder Cancer Kit, Cxbladder, ADXBLADDER, Urodiag) for bladder cancer diagnosis and for non-muscle invasive bladder cancer (NMIBC) follow-up.
All available studies on the 11 biomarkers published between May 2010 and March 2021 and present in MEDLINE were reviewed. The main endpoints were clinical performance for bladder cancer detection, recurrence or progression during NMIBC monitoring, and additional value compared to cytology and/or cystoscopy.
Most studies on urinary biomarkers had a prospective design and high level of evidence. However, their results should be interpreted with caution given the heterogeneity among studies. Most of the biomarkers under study displayed higher detection sensitivity compared with cytology, but lower specificity. Some biomarkers may have clinical utility for NMIBC surveillance in patients with negative or equivocal cystoscopy or negative or atypical urinary cytology findings, and also for recurrence prediction.
Urinary biomarkers might have a complementary place in bladder cancer diagnosis and NMIBC surveillance. However, their clinical benefit remains to be confirmed.
膀胱癌的检测与随访基于膀胱镜检查和/或细胞学检查，但这些方法仍存在不足且具有侵入性。当前的研究聚焦于诊断生物标志物，这些标志物可通过区分需要进行确诊性经尿道膀胱肿瘤切除术（TURBT）的侵袭性癌高危患者和可避免不必要检查的非侵袭性癌低危患者，来改善膀胱癌的检测与随访。
对11种尿液生物标志物（VisioCyt、XpertBladder、BTA stat、BTA TRAK™、NMP22 BC、NMP22 BladderChek Test、ImmunoCyt™/uCyt1+™、UroVysion膀胱癌检测试剂盒、Cxbladder、ADXBLADDER、Urodiag）用于膀胱癌诊断及非肌层浸润性膀胱癌（NMIBC）随访的临床有效性和临床实用性数据进行系统评价。
对2010年5月至2021年3月期间发表于MEDLINE且涉及这11种生物标志物的所有可用研究进行综述。主要终点为膀胱癌检测的临床性能、NMIBC监测期间的复发或进展情况，以及与细胞学检查和/或膀胱镜检查相比的附加价值。
大多数关于尿液生物标志物的研究采用前瞻性设计且证据水平较高。然而，鉴于研究之间的异质性，其结果应谨慎解读。大多数所研究的生物标志物与细胞学检查相比显示出更高的检测敏感性，但特异性较低。一些生物标志物可能对膀胱镜检查阴性或结果不明确、尿液细胞学检查阴性或不典型的患者进行NMIBC监测以及复发预测具有临床实用性。
尿液生物标志物在膀胱癌诊断和NMIBC监测中可能具有补充作用。然而，其临床益处仍有待证实。
