经尿道整块切除术与膀胱肿瘤标准切除术比较：一项随机、多中心、3 期临床试验。

Transurethral En Bloc Resection Versus Standard Resection of Bladder Tumour: A Randomised, Multicentre, Phase 3 Trial.

机构信息

S.H. Ho Urology Centre, Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong; Division of Urology, Department of Surgery, North District Hospital, Hong Kong.

Division of Urology, Department of Surgery, Pok Oi Hospital, Hong Kong; Division of Urology, Department of Surgery, Tuen Mun Hospital, Hong Kong.

出版信息

Eur Urol. 2024 Aug;86(2):103-111. doi: 10.1016/j.eururo.2024.04.015. Epub 2024 Apr 30.

DOI:10.1016/j.eururo.2024.04.015

PMID:38692956

Abstract

BACKGROUND AND OBJECTIVE

Conventionally, standard resection (SR) is performed by resecting the bladder tumour in a piecemeal manner. En bloc resection of the bladder tumour (ERBT) has been proposed as an alternative technique in treating non-muscle-invasive bladder cancer (NMIBC). The objective of this study is to investigate whether ERBT could improve the 1-yr recurrence rate of NMIBC, as compared with SR.

METHODS

A multicentre, randomised, phase 3 trial was conducted in Hong Kong. Adults with bladder tumour(s) of ≤ 3cm were enrolled from April 2017 to December 2020, and followed up until 1 yr after surgery. Patients were randomly assigned to receive either ERBT or SR in a 1:1 ratio. The primary outcome was 1-yr recurrence rate. A modified intention-to-treat analysis on patients with histologically confirmed NMIBC was performed. The main secondary outcomes included detrusor muscle sampling rate, operative time, hospital stay, 30-d complications, any residual or upstaging of disease upon second-look transurethral resection, and 1-yr progression rate.

KEY FINDINGS AND LIMITATIONS

A total of 350 patients underwent randomisation, and 276 patients were histologically confirmed to have NMIBC. At 1 yr, 31 patients in the ERBT group and 46 in the SR group developed recurrence; the Kaplan-Meier estimate of 1- yr recurrence rates were 29% (95% confidence interval, 18-37) in the ERBT group and 38% (95% confidence interval, 28-46) in the SR group (p = 0.007). Upon a subgroup analysis, patients with 1-3 cm tumour, single tumour, Ta disease, or intermediate-risk NMIBC had a significant benefit from ERBT. None of the patients in the ERBT group and three patients in the SR group developed progression to muscle-invasive bladder cancer; the Kaplan-Meier estimates of 1-yr progression rates were 0% in the ERBT group and 2.6% (95% confidence interval, 0-5.5) in the SR group (p = 0.065). The median operative time was 28 min (interquartile range, 20-45) in the ERBT group and 22 min (interquartile range, 15-30) in the SR group (p < 0.001). All other secondary outcomes were similar in the two groups.

CONCLUSIONS AND CLINICAL IMPLICATIONS

In patients with NMIBC of ≤ 3cm, ERBT resulted in a significant reduction in the 1-yr recurrence rate when compared with SR. The study results support ERBT as the first-line surgical treatment for patients with bladder tumours of≤ 3cm.

摘要

背景与目的

传统上，标准切除术（SR）通过分片切除膀胱肿瘤来进行。整块切除膀胱肿瘤（ERBT）已被提议作为治疗非肌肉浸润性膀胱癌（NMIBC）的替代技术。本研究旨在探讨 ERBT 是否能比 SR 降低 NMIBC 的 1 年复发率。

方法

这是一项在香港进行的多中心、随机、3 期临床试验。2017 年 4 月至 2020 年 12 月期间，纳入了肿瘤直径≤3cm 的膀胱肿瘤患者，并在手术后随访 1 年。患者按照 1:1 的比例被随机分配接受 ERBT 或 SR。主要终点是 1 年复发率。对组织学证实为 NMIBC 的患者进行了改良意向治疗分析。主要次要结局包括逼尿肌取样率、手术时间、住院时间、30 天并发症、二次经尿道膀胱肿瘤切除术时的任何残留或升级疾病、以及 1 年进展率。

主要发现和局限性

共有 350 例患者接受了随机分组，276 例患者的组织学证实为 NMIBC。在 1 年时，ERBT 组的 31 例和 SR 组的 46 例患者复发；ERBT 组的 1 年复发率估计值为 29%（95%置信区间，18-37），SR 组为 38%（95%置信区间，28-46）（p=0.007）。亚组分析显示，肿瘤直径为 1-3cm、单发肿瘤、Ta 疾病或中危 NMIBC 的患者从 ERBT 中获益显著。ERBT 组无患者进展为肌层浸润性膀胱癌，而 SR 组有 3 例患者进展为肌层浸润性膀胱癌；ERBT 组的 1 年进展率估计值为 0%，SR 组为 2.6%（95%置信区间，0-5.5）（p=0.065）。ERBT 组的中位手术时间为 28 分钟（四分位距，20-45），SR 组为 22 分钟（四分位距，15-30）（p<0.001）。两组的其他次要结局相似。