Robotic cystectomy shows noninferior long-term OS vs open cystectomy in urothelial carcinoma

Patients who underwent robotic-assisted radical cystectomy (RARC) for the management of urothelial carcinoma of the bladder showed no clinically significant difference in long-term survival outcomes compared with those who underwent open radical cystectomy (ORC), according to data presented at the 2023 AUA Annual Meeting in Chicago, Illinois.¹

The 30-day readmission rate was 10% among those who underwent RARC, compared with 9% among those who underwent ORC.

“There are limited randomized controlled trials that have investigated these 2 modalities–that being robotic radical cystectomy and open radical cystectomy–showing that generally speaking, they have a similar perioperative outcome, and in a limited 2-year follow-up, that they have similar progression-free survival. However, there's limited data showing long-term outcomes. So, with that, we developed an emulation study mimicking the real-world RAZOR study to try to investigate what the outcomes are,” said lead author, Joseph Black, MD, PhD, during the presentation on the findings. Black is a urology resident at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

In total, 3493 patients aged 37 to 89 years old were identified for analysis. Of those, 1001 (29%) underwent RARC with lymph node dissection (LND) and 2492 (71%) underwent ORC with LND. All patients had Charlson Comorbidity Index scores of 0 to 1 and received a diagnosis of cT1-4 cN0-1 cM0 urothelial carcinoma of the bladder from 2010 to 2015. The institutions at which patients were treated all performed an average of over 10 radical cystectomies per year.

The primary end point of the study was 5-year overall survival (OS), with secondary end points analyzing perioperative outcomes. Average follow-up was 29.5 months.

5-year OS was similar between the cohorts, with a rate of 57% among patients who underwent RARC, compared with 55% among those who underwent ORC (HR, 0.93; 95% CI, 0.80-1.07; P = .28). After adjustments for cT stage, cN stage, and age, no significant differences were observed in OS treatment effects.

There was also no significant difference found in positive surgical margins, with a rate of 8% observed among both cohorts (P = .64). The 30-day readmission rate was also similar, with a rate of 10% among those who underwent RARC, compared with 9% among those who underwent ORC (P = .80).

A statistically significant difference between the 2 groups was seen in median lymph node (LN) yield, with patients who underwent RARC experiencing a LN yield of 20, compared with 18 among patients who underwent ORC (P <.01). However, this difference was considered to be clinically insignificant. RARC was also associated with a shorter length of hospital stay compared with ORC (P <.01).

RAZOR trial data

The observational analysis was designed to emulate the phase 3 RAZOR trial (NCT01157676), which enrolled 350 patients with T1-T4, N0-N1, M0 bladder cancer or refractory carcinoma in situ.²

Patients in the study were randomized to receive robotic cystectomy (n = 176) or open cystectomy (n = 174). The primary end point of the study was 2-year progression-free survival (PFS). Safety end points were also included during the primary analysis.

Overall, 2-year PFS was similar among the 2 groups, with a rate of 72.3% (95% CI, 64.3-78.8) among those who underwent robotic cystectomy, compared with a rate of 71.6% (95% CI 63.6 to 78.2) among patients who underwent open cystectomy. Safety signals were also similar among the groups, with 101 (67%) patients in the robotic cystectomy cohort experiencing adverse events, compared with 105 (69%) patients in the open cystectomy cohort.

Urinary tract infection (UTI) and postoperative ileus were the most common adverse events experienced by patients. UTIs were experienced among 35% of those in the robotic cystectomy cohort and 26% of those in the open cystectomy group. Postoperative ileus was seen among 22% of those in the robotic cystectomy cohort and 20% of those in the open cystectomy cohort.

References

1. Black J, Kaul S, Fleishman A, et al. Robotic versus open radical cystectomy for urothelial carcinoma of the bladder. Presented at: American Urological Association Annual Meeting, April 28-May 1, Chicago. Abstract MP32-12. doi:10.1097/JU.0000000000003265.12

2. Parekh DJ, Reis IM, Castle EP, et al. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an open-label, randomized, phase 3, non-inferiority trial. Lancet. Published online June 23, 2018. Accessed June 20, 2023. doi: 10.1016/S0140-6736(18)30996-6