Background

The long-term oncological outcomes of laparoscopic (LRC) and robotic-assisted radical cystectomy (RARC) are still maturing compared with open radical cystectomy (ORC).

Objective

To evaluate the 5-yr oncological outcomes of patients recruited into the randomised trial of Open, Laparoscopic and Robot Assisted Cystectomy (CORAL) and extracorporeal urinary diversion.

Design, setting, and participants

A review of prospectively maintained database of 60 patients with muscle-invasive bladder cancer (MIBC) or high-risk nonmuscle-invasive bladder cancer (HRNMIBC) who were previously randomised in the CORAL trial to receive ORC, RARC, or LRC. This trial was designed to compare the perioperative and early oncological outcomes of these techniques.

Outcome measurements and statistical analysis

The outcomes of interest included 5-yr recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS). Kaplan–Meier curves were used to plot the recurrence and survival data. The curves between RFS, CSS, and OS were compared using the log-rank test. A two-sided p value <0.05 was considered significant. Results were analysed on the basis of intention to treat.

Results and limitations

A total of 60 patients with either MIBC (n = 38) or HRNMIBC (n = 21) were randomised in the CORAL trial to receive ORC, RARC, or LRC. The 5-yr RFS was 60%, 58%, and 71%; 5-yr CSS was 64%, 68%, and 69%; and 5-yr OS was 55%, 65%, and 61% for ORC, RARC, and LRC, respectively. There was no significant difference in RFS, CSS, and OS between the three surgical arms. The principal limitation is the small sample size.

Conclusions

There was no difference in 5-yr RFS, CSS, and OS rates of patients who underwent ORC, RARC, and LRC for management of bladder cancer. Minimally invasive techniques achieved equivalent oncological outcomes to the gold standard of ORC. However, the study was based at a single institution with a small sample size.

Patient summary

Patients who agreed to participate in the randomised trial of either open, laparoscopic, or robotic-assisted radical cystectomy for bladder cancer did not have different cancer outcomes at 5 yr.

中文翻译：

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从开放，机器人和腹腔镜根治性膀胱切除术（CORAL）的早期随机对照三臂试验的长期肿瘤学结果。

背景

与开放式根治性膀胱切除术（ORC）相比，腹腔镜（LRC）和机器人辅助根治性膀胱切除术（RARC）的长期肿瘤学结果仍然成熟。

客观的

为了评估入选开放，腹腔镜和机器人辅助膀胱切除术（CORAL）和体外导尿的随机试验患者的5年肿瘤学结局。

设计，设置和参与者

回顾性研究了60例患有肌肉浸润性膀胱癌（MIBC）或高危非肌肉浸润性膀胱癌（HRNMIBC）的患者的前瞻性数据库，这些患者先前在CORAL试验中随机分组接受ORC，RARC或LRC。该试验旨在比较这些技术的围手术期和早期肿瘤学结果。

成果测量和统计分析

感兴趣的结果包括5年无复发生存期（RFS），癌症特异性生存期（CSS）和总体生存期（OS）。Kaplan–Meier曲线用于绘制复发和生存数据。使用对数秩检验比较RFS，CSS和OS之间的曲线。双向p值<0.05被认为是显着的。根据治疗意图对结果进行了分析。

结果与局限性

 在CORAL试验中，共有60例MIBC（n  = 38）或HRNMIBC（n = 21）患者被随机分配接受ORC，RARC或LRC。5年RFS分别为60％，58％和71％；5年CSS分别为64％，68％和69％；ORC，RARC和LRC的5年OS分别为55％，65％和61％。三个手术臂之间的RFS，CSS和OS没有显着差异。主要限制是样本量小。

结论

接受ORC，RARC和LRC进行膀胱癌治疗的患者的5年RFS，CSS和OS率无差异。微创技术在肿瘤学上的疗效与ORC的金标准相当。但是，该研究是基于单个机构的样本量较小的。

病人总结

同意参加开放，腹腔镜或机器人辅助根治性膀胱切除术治疗膀胱癌的随机试验的患者在5年时没有不同的癌症预后。