Abstract: PNFLBA-18
Sources of Funding: National Cancer Institute - 5RO1CA155388

Introduction

Over 3 million surgeries have been performed globally using the surgical robot since its inception without level 1 evidence. We present the first phase 3 multicenter prospective randomized trial comparing an open to robotic approach for any organ site. Open radical cystectomy (ORC) and urinary diversion remains the gold standard management for invasive bladder cancer, however it is a complex procedure with significant perioperative morbidity. Robotic assisted RC (RARC) is a minimally invasive alternative to ORC with the promise of reducing perioperative morbidity without compromising oncological principles. The RAZOR trial compares open versus robotic cystectomy using oncologic, perioperative, functional and QOL endpoints.

Methods

Across 15 participating institutions in the United States, patients with biopsy proven bladder cancer; clinical stage T1-T4, N0-N1, M0 or carcinoma in situ (CIS) refractory to intravesical treatments were randomized to ORC or RAsRC in a 1:1 ratio. The trial was designed as a non-inferiority comparison with RARC being considered inferior if the 2-year progression-free survival (PFS) was >15% lower than ORC [Power = 80% and 2-sided significance level (alpha) = 5%]. Other endpoints included blood transfusion rate, estimated blood loss (EBL), length of stay (LOS), complications (Clavien-Dindo system), lymph node yield and margin status.

Results

A total of 350 patients were randomized. After exclusions, 150 in the RARC and 156 in the ORC arms were analyzed. Follow-up data is currently being reviewed and the 2-year PFS comparison is under analysis. Results are presented in Table 1. Estimated blood loss was significantly lower in the robotic arm translating into significantly lower blood transfusion rates. Major complications (Grade III and above) were similar in both groups. The number of lymph nodes removed was comparable and there was no significant difference in overall positive margin status. Positive bladder soft tissue margins were more common in the robotic arm. There was a trend to shorter LOS for RARC._x000D_

Conclusions

The 2 year oncologic outcomes will be ready for the AUA meeting. The robotic approach is associated with significantly lower EBL and transfusion rates than ORC with a trend to shorter LOS. There is no difference in the perioperative morbidity between the 2 approaches._x000D_

Funding

National Cancer Institute - 5RO1CA155388