Lozano Fernando, Raventós Carles Xavier, Carrión Albert, Trilla Enrique
Servicio Urología. Hospital Universitario Vall d'Hebron. Vall d´Hebron. Barcelona. España. Universitat Autónoma de Barcelona. Barcelona. España.
Arch Esp Urol. 2022 Mar;75(2):133-143.
Bladder cancer is thefifth most common tumor in the world. Moreover, it isone of the most expensive due to its high recurrencerate. Urinary biomarkers for surveillance of non muscleinvasive bladder cancer is a promising and growingfield due to the invasiveness of the actual methods, basedon cystoscopy and cytology. Although current EuropeanGuidelines only consider the use of biomarkersin the low risk scenario as an alternative to cystoscopywhen the patient declines invasive methods for the follow-up after surgery, there is increasing evidence oftheir safety in high risk tumors.
We have performeda review of the main urinary biomarkers, includingFDA-approved ones, protein-based and genetic biomarkers.We have also described the different options to incorporatethe biomarkers in the clinical practice.
There are not randomized control trialscomparing any biomarker with the gold standard follow-up. Most of the papers published so far are cohortstudies, limitating the evidence of the results. Biomarkerscan be used as an alternative of cystoscopy, in a noninvasive follow-up, or alternating both tests. There arefew economical studies comparing both options, but theevidence supports the efficiency of the main biomarkers.
Cystoscopy and cytology are the goldstandard for non muscle invasive bladder cancer surveillance.2021 European Guidelines suggest, for the firsttime, an alternative use of biomarkers in a concrete lowgrade scenario to avoid invasive explorations to patientswith low risk of progression. Paradoxically, biomarkers(mainly genetic ones) have a very good profile of sensitivityand negative predictive value in the high risk scenario.Although there is increasing evidence to supporttheir implementation, the lack of fase IV trials hinderstheir daily use.
膀胱癌是全球第五大常见肿瘤。此外，由于其高复发率，它也是最昂贵的肿瘤之一。由于基于膀胱镜检查和细胞学的现有方法具有侵入性，用于监测非肌层浸润性膀胱癌的尿液生物标志物是一个有前景且不断发展的领域。尽管当前欧洲指南仅在低风险情况下考虑使用生物标志物作为膀胱镜检查的替代方法，即当患者拒绝接受侵入性术后随访方法时，但越来越多的证据表明它们在高风险肿瘤中是安全的。
我们对主要的尿液生物标志物进行了综述，包括美国食品药品监督管理局（FDA）批准的生物标志物、基于蛋白质的生物标志物和基因生物标志物。我们还描述了将这些生物标志物纳入临床实践的不同选择。
尚无将任何生物标志物与金标准随访进行比较的随机对照试验。迄今为止发表的大多数论文都是队列研究，这限制了结果的证据。生物标志物可作为膀胱镜检查的替代方法，用于无创随访，或两者交替使用。很少有经济学研究比较这两种选择，但证据支持主要生物标志物的有效性值得信赖。
膀胱镜检查和细胞学检查是监测非肌层浸润性膀胱癌的金标准。2021年欧洲指南首次建议，在特定的低级别情况下可替代使用生物标志物，以避免对进展风险低的患者进行侵入性检查。矛盾的是，生物标志物（主要是基因生物标志物）在高风险情况下具有非常好的敏感性和阴性预测值。尽管有越来越多的证据支持其应用，但缺乏IV期试验阻碍了它们的日常使用。
需注意，你提供的原文最后一句“the lack of fase IV trials hinderstheir daily use.”中“fase”可能有误，我按正确理解翻译为“IV期”。若原文无误，请告知我以便我准确翻译。
