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磁共振成像与经尿道切除术用于新诊断膀胱癌分期的随机对照比较:前瞻性膀胱路径试验的结果

Randomized Comparison of Magnetic Resonance Imaging Versus Transurethral Resection for Staging New Bladder Cancers: Results From the Prospective BladderPath Trial.

作者信息

Bryan Richard T, Liu Wenyu, Pirrie Sarah J, Amir Rashid, Gallagher Jean, Hughes Ana I, Jefferson Kieran P, Knight Allen, Nanton Veronica, Mintz Harriet P, Pope Ann M, Cherian Jacob, Ekwueme Kingsley, Gommersall Lyndon, Hellawell Giles, Hunter-Campbell Paul, Kanda Swamy Gokul, Kotwal Sanjeev, Kumar Vivekanandan, Mak David, Mohee Amar, Nambirajan Thiagarajan, Ward Douglas G, Kennish Steven J, Catto James W F, Patel Prashant, James Nicholas D

机构信息

Bladder Cancer Research Centre, Department of Cancer and Genomic Sciences, University of Birmingham, Birmingham, United Kingdom.

The Translational Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom.

出版信息

J Clin Oncol. 2025 Apr 20;43(12):1417-1428. doi: 10.1200/JCO.23.02398. Epub 2025 Jan 14.

Abstract

PURPOSE

Transurethral resection of bladder tumor (TURBT) is the initial staging procedure for new bladder cancers (BCs). For muscle-invasive bladder cancers (MIBCs), TURBT may delay definitive treatment. We investigated whether definitive treatment can be expedited for MIBC using flexible cystoscopic biopsy and multiparametric magnetic resonance imaging (mpMRI) for initial staging.

PATIENTS AND METHODS

We conducted a prospective open-label, randomized study conducted within 17 UK hospitals (registered as ISRCTN 35296862). Participants with suspected new BC were randomly assigned 1:1 to TURBT-staged or mpMRI-staged care, with minimization factors of sex, age, and clinician visual assessment of stage. Blinding was not possible. Patients unable/unwilling to undergo mpMRI or with previous BC were ineligible. The study had two stages with separate primary outcomes of feasibility and time to correct treatment (TTCT) for MIBC, respectively.

RESULTS

Between May 31, 2018, and December 31, 2021, 638 patients were screened, and 143 participants randomly assigned to TURBT (n = 72; 55 males, 15 MIBCs) or initial mpMRI (n = 71; 53 males, 14 MIBCs). For feasibility, 36 of 39 (92% [95% CI, 79 to 98]) participants with suspected MIBC underwent mpMRI. The median TTCT for participants with MIBC was significantly shorter with initial mpMRI (n = 12, 53 days [95% CI, 20 to 89] n = 14, 98 days [95% CI, 72 to 125] for TURBT, log-rank .02). There was no detriment for participants with non-MIBC (median TTCT: n = 30, 17 days [95% CI, 8 to 25] for mpMRI n = 28, 14 days [95% CI, 10 to 29] for TURBT, log-rank = .67). No serious adverse events were reported.

CONCLUSION

The mpMRI-directed pathway led to a 45-day reduction in TTCT for MIBC. Incorporating mpMRI ahead of TURBT into the standard pathway was beneficial for all patients with suspected MIBC.

摘要

目的

经尿道膀胱肿瘤切除术(TURBT)是新发膀胱癌(BC)的初始分期手术。对于肌层浸润性膀胱癌(MIBC),TURBT可能会延迟确定性治疗。我们研究了使用软性膀胱镜活检和多参数磁共振成像(mpMRI)进行初始分期是否可以加快MIBC的确定性治疗。

患者与方法

我们在英国的17家医院进行了一项前瞻性开放标签随机研究(注册号为ISRCTN 35296862)。疑似新发BC的参与者按1:1随机分配至TURBT分期或mpMRI分期治疗组,将性别、年龄和临床医生对分期的视觉评估作为最小化因素。无法实施盲法。无法/不愿接受mpMRI检查或既往有BC病史的患者不符合入组条件。该研究分为两个阶段,分别以可行性和MIBC的正确治疗时间(TTCT)作为各自的主要结局指标。

结果

在2018年5月31日至2021年12月31日期间,共筛查了638例患者,143名参与者被随机分配至TURBT组(n = 72;55例男性,15例MIBC)或初始mpMRI组(n = 71;53例男性,14例MIBC)。对于可行性,39例疑似MIBC的参与者中有36例(92%[95%CI,79%至98%])接受了mpMRI检查。MIBC参与者的中位TTCT在初始mpMRI组显著缩短(n = 12,53天[95%CI,20至89天];TURBT组n = 14,98天[95%CI,72至125天],对数秩检验P = 0.02)。非MIBC参与者未受影响(中位TTCT:mpMRI组n = 30,17天[95%CI,8至25天];TURBT组n = 28,14天[95%CI,10至29天],对数秩检验P = 0.67)。未报告严重不良事件。

结论

mpMRI引导的治疗路径使MIBC的TTCT缩短了45天。在TURBT之前将mpMRI纳入标准治疗路径对所有疑似MIBC患者均有益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c5e0/12005870/d1eabb20d1b0/jco-43-1417-g001.jpg

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