In a systematic review published in 2015, assessing the perioperative outcome and complications after RARC1, almost all studies showed a clear advantage to RARC over open radical cystectomy regarding blood loss and transfusion rates. In this systematic review, no differences were seen in the intraoperative complication rate, while the operative time was significantly shorter in open radical cystectomy.
Dr. Wiklund then presented Swedish national data demonstrating that in recent years, the operative time of robotic cystectomy had shortened significantly and currently it is equal to the operating time of open radical cystectomy. He compared data from the Swedish registry to data from his center, the Karolinska institution, showing that in his center there is a higher rate of neobladder creation (32% vs. 11%), and increased rate of extended lymph node dissection (74% vs. 21.3%).
Next, Dr. Wiklund presented a study comparing recurrence patterns between open and robotic radical cystectomy.2 This study demonstrated that RARC has similar recurrence rates as open radical cystectomy. However, recurrences in extrapelvic lymph node locations and peritoneal carcinomatosis were more common in RARC, warranting further study. He then presented a large retrospective study of the international robotic cystectomy consortium. This consortium has a multi-institutional database that included 702 patients from 11 institutions in 6 countries, who underwent RARC more than five years before the publication of this study. This study examined the long-term oncological outcomes after RARC,3 and demonstrated that incision or port site metastases and multiple unusual recurrences only occurred in one patient.
Up until this point, Dr. Wiklund discussed only retrospective studies. At this point he mentioned the two prospective studies available, comparing RARC to open radical cystectomy. In the Memorial Sloan Kettering randomized trial, only 118 patients were randomized to either RARC or open radical cystectomy.4 In both groups of this study, the percentage of lymph node-positive disease and positive surgical margins were similar. The study showed no difference in the recurrence rates in both groups. Furthermore, there was no difference in the death rates between the groups after a median follow-up of 4.9 years. However, the pattern of the first recurrence demonstrated a non-statistically significant increase in metastatic sites for patients in the open radical cystectomy group with a hazard ratio of 2.21, p=0.064. This study was greatly limited by the lack of power to determine differences in cancer recurrences or survival outcomes.
The next trial discussed was the recently published and largest prospective randomized trial to date, comparing RARC to open radical cystectomy. The RAZOR study was a randomized, open-label, non-inferiority, phase 3 trial done in 15 centers in the US.5 Overall, approximately 150 patients were randomized to each group. The results demonstrated that the two-year progression-free survival was 72.3% in the RARC group compared to 71.6% in the open cystectomy group. Adverse events were similar in both groups with a prevalence of 67% and 69% in both groups.
At the end of his discussion, Dr. Wiklund gave some data from his institution, a large robotic center. He demonstrated that after a long follow-up of 5 years, the cancer-specific survival was similar between RARC and open radical cystectomies performed in his center. However, when stratified to only patients with pT3 disease or above, the cancer-specific survival rate was better in the RARC patients, p=0.02, as depicted in figure 1. Looking at the complication rates, the data showed that the rate hospitalization in the intensive care unit was higher in the open radical cystectomy group, (6.6% vs. 2.8%), as was the rate of complications (9.9% vs. 5.1%). He also showed some data on continence and potency that were similar, if not better in the RARC group. Lastly, although the urinary diversion was done in an extracorporeal approach when the center had just begun performing robotic surgery, according to Dr. Wiklund, currently almost all urinary diversions are performed in an intracorporeal technique.
Dr. Wiklund summarized his talk reiterating that RARC has excellent oncological outcomes, with comparable positive surgical margin rate and lymph node counts as in open radical cystectomy. There is no strong evidence to support unusual recurrences in RARC, such as port-site metastasis. Lastly, early recurrence rates following totally intracorporeal RARC are similar to published open radical cystectomy series.
Figure 1 – Karolinska institute data of cancer-specific survival in robotic and open radical cystectomy: (a) for all patients (b) for patients with <=pT2 disease only (c) for patients with >pT3 disease only
(a)
(b)
(c)
Presented by: Professor Peter Wiklund, Karolinska Institutet, Sweden
Written By: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the Global Conference on Bladder Cancer 2018 - September 20-21, 2018 Madrid, Spain
References:
1. Novara G et al. Eur Urol 2015
2. Ngyuen DP et al. Eur Urol 2015
3. Raza SJ et al. Eur Urol 2015
4. Bochner BH et al. Eur Urol 2018
5. Parekh DJ, et al. Lancet, 2018