Urologie 24, Nürnberg, Germany.
Institute for Prevention and Occupational Medicine of the German Social Accidence Insurance, Institute of the Ruhr University Bochum (IPA), Bochum, Germany.
Urol Oncol. 2020 Dec;38(12):886-895. doi: 10.1016/j.urolonc.2020.01.006. Epub 2020 Mar 18.
Follow-up recommendations for patients with nonmuscle invasive bladder cancer (NMIBC) are largely based upon expert opinion. A growing body of evidence suggests that current follow-up strategies for bladder cancer patients with low and intermediate risk represent overdiagnosis and may lead to overtreatment. The goal of this study is to explore the options of a noninvasive follow-up in patients with pTa G1-2/low-grade NMIBC.
The risks and options for a urine marker-guided, noninvasive follow-up of patients with pTa G1-2/low-grade NMIBC were defined and the study design for a prospective randomized trial (UroFollow) was developed based upon the current literature.
The investigators postulated that follow-up of patients with pTa G1-2/low-grade NMIBC requires a high sensitivity of urinary tumor markers. However, data from prospective studies with prediagnostic urine samples are scarce, even for approved markers, and cross-sectional studies with symptomatic patients overestimate the sensitivity. So far, cell-based markers (e.g., uCyt+ and UroVysion) in urine appeared to have higher sensitivities and specificities in low-grade NMIBC than urine cytology and markers analyzing soluble tumor-associated antigens. Marker panels are more sensitive than single-marker approaches at the expense of a lower specificity. Given a prospective randomized comparison with a marker sensitivity of 80% compared to usual care with cystoscopy, the sample size calculation yielded that 62 to 185 patients under study per arm are needed depending on different recurrence rates.
Based upon these findings the UroFollow trial has been designed as a prospective randomized study comparing a noninvasive marker-based (UroVysion, NMP22, urine cytology, and ultrasound) follow-up with the current standard of care over a period of 3 years.
非肌肉浸润性膀胱癌（NMIBC）患者的随访建议主要基于专家意见。越来越多的证据表明，目前低危和中危膀胱癌患者的随访策略存在过度诊断的可能，并可能导致过度治疗。本研究的目的是探讨在 pTa G1-2/低级别 NMIBC 患者中进行非侵入性随访的选择。
根据当前文献，确定了尿标志物指导的 pTa G1-2/低级别 NMIBC 患者非侵入性随访的风险和选择，并制定了前瞻性随机试验（UroFollow）的研究设计。
研究人员推测，pTa G1-2/低级别 NMIBC 患者的随访需要尿肿瘤标志物具有较高的灵敏度。然而，即使对于已批准的标志物，来自前瞻性预诊断尿液样本的研究数据也很少，而对有症状患者的横断面研究高估了其灵敏度。迄今为止，尿液中的基于细胞的标志物（例如 uCyt+ 和 UroVysion）在低级别 NMIBC 中的灵敏度和特异性似乎高于尿液细胞学和分析可溶性肿瘤相关抗原的标志物。与单标志物方法相比，标志物组合的灵敏度更高，但特异性较低。与常规膀胱镜检查相比，前瞻性随机比较标志物灵敏度为 80%，预计每个研究组需要 62 至 185 名患者，具体取决于不同的复发率。
基于这些发现，UroFollow 试验被设计为一项前瞻性随机研究，比较了 3 年期间基于非侵入性标志物（UroVysion、NMP22、尿液细胞学和超声）的随访与当前的标准护理。
