Plenary: Next Frontier, Monday
Plenary: Next Frontier
Presentation Authors: Dipen Parekh*, Coral Gables, FL
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.
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.
Source Of Funding: National Cancer Institute - 5RO1CA155388
University of Miami
Dipen J. Parekh, M.D.
Professor and Chairman
The Victor Politano Endowed Chair in Urology and Director of Robotic Surgery
Department of Urology the University of Miami Miller School of Medicine
Dipen J. Parekh, M.D. is an expert in the prevention, diagnosis and treatment of urologic malignancies.
Dr. Parekh earned his M.D. from Poona University and completed residencies in general surgery and urology at Mumbai University. He completed a residency in urology at Vanderbilt University Medical Center and a fellowship in urologic oncology at Memorial Sloan Kettering Cancer Center in New York. He was the Doctors Hospital at Renaissance Distinguished University Chair in Urology and Chief of Robotic Surgery and Urologic Oncology at the University of Texas at San Antonio before joining the University of Miami in 2012 as Professor and Chair of the Department of Urology and the Director of Robotic Surgery, The Victor A Politano Endowed Chair in Urology.Dr. Parekh holds a Masters in Healthcare Administration from Trinity University, San Antonio, Texas. In 2013, Dr Parekh was selected by the American Urological Association (AUA) as the recipient of the Gold Cytoscope Award, one of the most prestigious awards bestowed upon any one urologist each He was also the 2014 recipient of the American Association of Physicians of Indian Origin “Most Distinguished Physician Award.” The organization selects 1 from a pool of 35,000 practicing physicians. Dr Parekh has one of the largest experiences in the world in performing robotic surgeries for urologic malignancies including prostate, kidney and bladder cancers.His research interests have led to transformative discoveries in the understanding of human renal inschemia, novel biomarkers for prostate cancer, and the only phase 3 multiinstitutional randomized clinical trial comparing robotic to open radical cystectomy for bladder cancer funded by the National Cancer Institute.
Sunday, May 14
1:00 PM – 3:00 PM
Sunday, May 14
4:30 PM – 4:45 PM
Monday, May 15
11:20 AM – 11:25 AM
Monday, May 15
1:00 PM – 1:30 PM