Schmitz-Dräger Bernd J, Bismarck Ekkehardt, Roghmann Florian, von Landenberg Nicolas, Noldus Joachim, Jahn Daniela, Kernig Karoline, Hakenberg Oliver W, Goebell Peter J, Hennenlotter Jörg, Erne Eva, Stenzl Arnulf, Rowinski Maciej, Schiffhorst Guido, Baranek Thomas, Benderska-Söder Natalya
Department of Urology and Pediatric Urology, Friedrich-Alexander University, Erlangen, Germany; Urologie 24, St. Theresien Hospital, Nürnberg, Germany.
Urologie 24, St. Theresien Hospital, Nürnberg, Germany.
Eur Urol Oncol. 2025 May 7. doi: 10.1016/j.euo.2025.04.020.
A growing body of evidence suggests that the intensity of current follow-up in non-muscle-invasive bladder cancer (NMIBC) patients greatly exceeds clinical necessities. The UroFollow trial investigated the diagnostic accuracy of marker-based follow-up in patients with low/intermediate-risk NMIBC against the standard of care (SOC) for noninferiority (margin: <20%).
Patients with Ta low- and high-grade (G1-2) NMIBC were randomized to the SOC or 6-monthly marker-based follow-up (algorithm comprising urine markers and ultrasound; marker-based surveillance regimen [MA]). After a negative 3-mo cystoscopy (white light cystoscopy [WLC]), only patients with a positive algorithm underwent WLC in the MA. End-of-study WLC was recommended at 3 yr to recurrence-free patients. Simultaneously, several innovative urine markers were examined.
In total, 214 patients were randomized to the SOC (n = 109) and MA (n = 105). The median follow-up was 2.4 yr; 30 and 29 cases of tumor recurrence were diagnosed in the SOC and MA arms, respectively. Sensitivity was 96.5% versus 81.5% (p = 0.1), with one and five Ta low-grade tumors being overlooked in the SOC and MA patients, respectively. No tumor progressing in stage or grade was missed. A total of 589 WLC procedures were performed in the SOC and 148 in the MA arm (p < 0.001). Among five other markers (ADX-Bladder, CellDetect, Bladder EpiCheck, UBC rapid, and Xpert bladder cancer monitor [BC-M]), Bladder EpiCheck and the Xpert BC-M showed similar performance to the algorithm.
UroFollow is the first urine marker-based randomized trial in low/intermediate-risk NMIBC patients. We conclude that 6-monthly marker-based follow-up after negative 3-mo WLC is safe in this cohort. Results of contemporary urine markers suggest that their potential for use in marker-based surveillance, however, requires prospective confirmation.
越来越多的证据表明，目前对非肌层浸润性膀胱癌（NMIBC）患者的随访强度大大超过了临床需求。UroFollow试验针对低/中危NMIBC患者，对照标准治疗（SOC），研究了基于标志物的随访在非劣效性方面（界值：<20%）的诊断准确性。
Ta期低级别和高级别（G1-2）NMIBC患者被随机分为接受SOC或每6个月进行一次基于标志物的随访（方案包括尿液标志物和超声检查；基于标志物的监测方案[MA]）。在3个月的膀胱镜检查（白光膀胱镜检查[WLC]）结果为阴性后，MA组中只有算法结果为阳性的患者接受WLC检查。建议无复发患者在3年时进行研究结束时的WLC检查。同时，对几种新型尿液标志物进行了检测。
共有214例患者被随机分为SOC组（n = 109）和MA组（n = 105）。中位随访时间为2.4年；SOC组和MA组分别诊断出30例和29例肿瘤复发。敏感性分别为96.5%和81.5%（p = 0.1），SOC组和MA组分别有1例和5例Ta期低级别肿瘤被漏诊。没有遗漏任何分期或分级进展的肿瘤。SOC组共进行了589次WLC检查，MA组进行了148次（p < 0.001）。在其他五种标志物（ADX-Bladder、CellDetect、Bladder EpiCheck、UBC rapid和Xpert膀胱癌监测仪[BC-M]）中，Bladder EpiCheck和Xpert BC-M的表现与该算法相似。
UroFollow是第一项针对低/中危NMIBC患者的基于尿液标志物的随机试验。我们得出结论认为，在3个月WLC检查结果为阴性后，每6个月进行一次基于标志物的随访在该队列中是安全的。当代尿液标志物的结果表明，它们在基于标志物的监测中的应用潜力仍需要前瞻性证实。
