Bladder CancerLong-term Oncological Outcomes from an Early Phase Randomised Controlled Three-arm Trial of Open, Robotic, and Laparoscopic Radical Cystectomy (CORAL)
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 In the LRC group, one patient randomised to LRC was withdrawn from the trial after further review of the histology by the specialist bladder cancer pathologist team panel changed the diagnosis to small cell bladder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)
- et al.
Outcomes of radical cystectomy for transitional cell carcinoma of the bladder: a contemporary series from the Bladder Cancer Research Consortium
J Urol
(2006) - et al.
Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology
Eur Urol
(2009) - et al.
A single-centre early phase randomised controlled three-arm trial of open, Robotic, and Laparoscopic Radical Cystectomy (CORAL)
Eur Urol
(2016) - et al.
Systematic review and meta-analysis of comparative studies reporting early outcomes after robot-assisted radical cystectomy versus open radical cystectomy
Cancer Treat Rev
(2013) - et al.
Robotic vs. open radical cystectomy in bladder cancer: a systematic review and meta-analysis
Eur J Surg Oncol
(2014) - et al.
The importance of surgeon characteristics on impacting oncologic outcomes for patients undergoing radical cystectomy
J Urol
(2014) - et al.
Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study
Lancet
(2016) - et al.
Perioperative outcomes and oncologic efficacy from a pilot prospective randomized clinical trial of open versus robotic assisted radical cystectomy
J Urol
(2013) - et al.
Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results
Eur Urol
(2010) - et al.
Comparing open radical cystectomy and robot-assisted laparoscopic radical cystectomy: a randomized clinical trial
Eur Urol
(2015)
Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomised, phase 3, non-inferiority trial
Lancet
Positive surgical margins in soft tissue following radical cystectomy for bladder cancer and cancer specific survival
J Urol
Outcome after radical cystectomy with limited or extended pelvic lymph node dissection
J Urol
Super extended versus extended pelvic lymph node dissection in patients undergoing radical cystectomy for bladder cancer: a comparative study
J Urol
Impact of the number of lymph nodes retrieved on outcome of patients with muscle invasive bladder cancer
J Urol
Soft tissue surgical margin status is a powerful predictor of outcomes after radical cystectomy: a multicenter study of more than 4,400 patients
J Urol
Complications after robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium
Eur Urol
Standardization of radical cystectomy and pelvic lymph node dissection for bladder cancer: a collaborative group report
J Urol
Standardized analysis of frequency and severity of complications after robot-assisted radical cystectomy
Eur Urol
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