AUA 2017: A Prospective, Multicenter, Randomized Trial of Open Versus Robotic Radical Cystectomy (RAZOR)
Dr. Parekh noted that this is the first phase 3, multicenter, prospective randomized trial comparing an open to robotic approach for any organ site. The RAZOR trial aimed to compare open (ORC) versus robotic cystectomy (RARC) using oncologic, perioperative, functional and QOL endpoints. To do this, RAZOR used 15 participating institutions in the United States and included patients with biopsy proven bladder cancer: clinical stage T1-T4, N0-N1, M0 or carcinoma in situ (CIS) refractory to intravesical treatments. The trial was designed and powered as a non-inferiority comparison with RARC being considered inferior if the 2-year progression-free survival (PFS) was >15% lower than ORC. A total of 350 patients were randomized 1:1 to receive ORC or RARC. After exclusions, 151 in the RARC and 156 in the ORC arms were analyzed. RARC was associated with a higher bladder soft tissue margin (10.6% vs 4.5%, p=0.042), longer operative time (425 vs 361 min, p<0.001), shorter median hospital stay (6.5 vs 7 days, p=0.023), associated with more patients staying ≤5 days (28.6% vs 18.7%), less estimated blood loss (mean 363 vs 829, p<0.001), less frequent intraoperative transfusions (13.6% vs 33.6%, p<0.001), and less post-operative transfusions (25.6% vs 41.0%) compared to ORC. There was no difference in extensiveness of lymph node dissection, complications or final pathology between the two arms. There was no difference in 2-year progression-free survival or overall survival (80.2% vs 79.1%, HR 0.80, p=0.31).
Dr. Parekh concluded that based on this level 1 evidence, RARC is not inferior to ORC for both progression free- and overall survival. Furthermore, there are perioperative advantages to RARC compared to ORC. Patient selection and appropriate surgeon skill level with each radical cystectomy modality remain key considerations.
Speaker: Dipen Parekh, University of Miami, Miami, FL, USA
Co-Authors: None
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre
Twitter: @zklaassen_md
at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA