Elsevier

European Urology

Volume 77, Issue 1, January 2020, Pages 110-118
European Urology

Bladder Cancer
Long-term Oncological Outcomes from an Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL)

https://doi.org/10.1016/j.eururo.2019.10.027Get rights and content

Abstract

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.

Introduction

Radical cystectomy, although a highly morbid procedure, remains the standard of care for muscle-invasive bladder cancer (MIBC) and high-risk nonmuscle-invasive bladder cancer (HRNMIBC) where bladder preservation treatments have failed [1], [2]. Open radical cystectomy (ORC) is accepted as the gold standard because its long-term oncological outcomes are well-established [3], [4]. In an endeavour to minimise the perioperative morbidity, minimally invasive radical cystectomy (MIRC) techniques such as laparoscopic (LRC) and robotic-assisted (RARC) radical cystectomy have been developed.

The main findings from our previously published CORAL Trial demonstrated reduced blood loss and shorter hospital stay with the minimally invasive approaches. We found no significant differences in 90-d complication rates and oncological outcomes among the randomised groups [5]. Several other studies have shown lower complication rates for RARC compared with ORC [6], [7], [8], [9], but evidence on the long-term oncological outcomes of MIRC is still maturing.

This article aims to report long-term oncological outcomes of the three-arm CORAL trial (open, laparoscopic, and robotic), a randomised trial of radical cystectomy.

Section snippets

Patients and methods

Patients’ eligibility for trial inclusion, the randomisation process, and the technical aspects of ORC, RARC, and LRC were previously described [5]. All operations were performed at Guy's Hospital London by three expert surgeons (MSK, PD, and PR) who were all well over their learning curves for their respective operative modalities. Urinary diversions were performed extracorporeally in both laparoscopic and robotic subgroups and pelvic lymph node (LN) dissection was performed in all arms.

At

Results

A total of 60 patients agreed to participate in the study and were randomised to receive either ORC, LRC, or RARC. All 20 patients who were randomised to ORC underwent the assigned procedure. In the RARC arm, one patient was converted to ORC due to equipment failure. In the LRC group, one patient randomised to LRC was withdrawn from the trial after further review of the histology by the specialist bladder cancer pathologist team panel changed the diagnosis to small cell bladder cancer. Surgery

Discussion

Minimally invasive approaches in the treatment of benign or malignant conditions have been embraced widely in all surgical specialties, but none more so than in urology. The minimally invasive techniques provide important benefits such as reduced blood loss, quicker recovery, shorter hospital stay, and reduced wound complications [10], [11]. However, aside from these perioperative benefits, there is as yet little evidence to suggest that these approaches yield superior oncological outcomes,

Conclusions

Based on our observation, there was no difference in 5-yr RFS, CSS, and OS of patients who underwent ORC, RARC, and LRC. Minimally invasive techniques achieved similar oncological outcomes to the gold standard of ORC. However, the results need to be interpreted with caution due to the small sample size. These results from the only randomised trial comparing all three approaches with radical cystectomy should provide some reassurance to the clinicians and the patients.

Author contributions:

References (38)

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