Ecke Thorsten H, Benderska-Söder Natalya, Bismarck Ekkehardt, van Rhijn Bas W G, Todenhöfer Tilman, Schmitz-Dräger Bernd J
Department of Urology, Helios Hospital, Bad Saarow, Germany.
Department of Urology, Universitätsmedizin Berlin Charité, Berlin, Germany.
Methods Mol Biol. 2023;2684:199-212. doi: 10.1007/978-1-0716-3291-8_12.
Although a plethora of urine markers for diagnosis and follow-up of patients with bladder cancer (BC) has been developed and studied, the clinical impact of urine testing on patient management remains unclear. The goal of this manuscript is to identify scenarios for a potential use of modern point-of-care (POC) urine marker assays in the follow-up of patients with high-risk non-muscle-invasive BC (NMIBC) and estimate potential risks and benefits.
To permit comparison between different assays, the results of 5 different POC assays studied in a recent prospective multicenter study including 127 patients with suspicious cystoscopy undergoing TURB were used for this simulation. For the current standard of care (SOC), a "marker-enforced" procedure, and a combined strategy sensitivity (Se), estimated number of cystoscopies, and the numbers needed to diagnose (NND) over a 1-year follow-up period were calculated.
For regular cystoscopy (SOC), a Se of 91.7% and a NND of 42.2 repetitive office cystoscopies (WLCs) for 1 recurrent tumor at 1 year were calculated. For the "marker-enforced" strategy, marker sensitivities between 94.7% and 97.1% were observed. The "combined" strategy yielded for markers with a Se exceeding 50% an overall Se at 1 year similar or superior to the current SOC. Savings regarding the number of cystoscopies in the "marker-enforced" strategy vs. the SOC were small, while, depending on the marker, up to 45% of all cystoscopies may be saved using the "combined" strategy.
Based on the results of this simulation, a marker-supported follow-up of patients with high-risk (HR) NMIBC is safe and offers options to significantly reduce the number of cystoscopies without compromising the Se. Further research focusing on prospective randomized trials is needed to finally find a way to include marker results into clinical decision-making.
尽管已经开发并研究了大量用于膀胱癌（BC）患者诊断和随访的尿液标志物，但尿液检测对患者管理的临床影响仍不明确。本手稿的目的是确定在高危非肌层浸润性膀胱癌（NMIBC）患者随访中潜在使用现代即时检验（POC）尿液标志物检测的情况，并估计潜在风险和益处。
为了便于不同检测方法之间的比较，本模拟使用了最近一项前瞻性多中心研究中5种不同POC检测方法的结果，该研究包括127例接受经尿道膀胱肿瘤切除术（TURB）且膀胱镜检查可疑的患者。对于当前的标准治疗（SOC）、“标志物强化”程序和联合策略，计算了1年随访期内的敏感性（Se）、估计的膀胱镜检查次数以及诊断所需次数（NND）。
对于常规膀胱镜检查（SOC），计算得出1年内1例复发性肿瘤的Se为91.7%，NND为42.2次重复性门诊膀胱镜检查（WLC）。对于“标志物强化”策略，观察到标志物敏感性在94.7%至97.1%之间。对于Se超过50%的标志物，“联合”策略在1年内产生的总体Se与当前SOC相似或更高。“标志物强化”策略与SOC相比，膀胱镜检查次数的节省较少，而根据标志物的不同，使用“联合”策略最多可节省45%的膀胱镜检查次数。
基于该模拟结果，对高危（HR）NMIBC患者进行标志物支持的随访是安全的，并提供了在不影响Se的情况下显著减少膀胱镜检查次数的选择。需要进一步开展前瞻性随机试验研究，以最终找到将标志物结果纳入临床决策的方法。
