背景:通常,标准切除术(SR)是通过以零碎的方式切除膀胱肿瘤来进行的。已提出膀胱肿瘤整块切除术(ERBT)作为治疗非肌肉浸润性膀胱癌(NMIBC)的替代技术。
目的:探讨ERBT能否改善NMIBC的1年复发率,与SR相比。
方法:多中心,随机化,3期试验在香港进行.从2017年4月至2020年12月纳入膀胱肿瘤≤3cm的成年人,并随访至手术后1年。
方法:患者被随机分配接受1:1比例的ERBT或SR。
方法:主要结果是1年复发率。对组织学证实为NMIBC的患者进行了改良的意向治疗分析。主要次要结果包括逼尿肌采样率,手术时间,住院,30d并发症,经尿道二次电切术后任何残留或升级的疾病,和1年进展率。
结论:共有350名患者接受了随机分组,276例患者经组织学证实患有NMIBC。在1年,ERBT组31例,SR组46例复发;Kaplan-Meier估计的1年复发率为29%(95%置信区间,18-37)在ERBT组中,38%(95%置信区间,28-46)在SR组中(p=0.007)。根据亚组分析,1-3厘米肿瘤患者,单个肿瘤,Ta病,或中等风险的NMIBC从ERBT中获益显著.ERBT组的患者和SR组中的三名患者均未发展为肌肉浸润性膀胱癌;ERBT组的Kaplan-Meier估计的1年进展率分别为0%和2.6%(95%置信区间,0-5.5)在SR组(p=0.065)。中位手术时间为28分钟(四分位距,20-45)在ERBT组中和22分钟(四分位数间距,15-30)在SR组中(p<0.001)。两组的其他次要结局相似。
结论:在NMIBC≤3cm的患者中,与SR(由GRF/ECS资助,RGC,参考编号:24116518;ClinicalTrials.gov编号,NCT02993211)。
结果:按惯例,非肌肉浸润性膀胱癌是通过局部切除膀胱肿瘤来治疗的。在这项研究中,我们发现整块切除,也就是说,一块切除膀胱肿瘤,可以降低非肌层浸润性膀胱癌的1年复发率。
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.
UNASSIGNED: 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: 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.