EAU 2019: Healthy Male Patient Undergoing Radical Cystectomy, Undecided on Diversion: Open

Barcelona, Spain (UroToday.com) In the Common Problems in Muscle Invasive and Advanced Bladder Cancer: Evidence-Based Debates session at the 2019 European Association of Urology meeting EAU 2019, Dr. Juan Palou presented the following case to facilitate the debate between Drs. Agarwal and Lerner titled: "Healthy Male Patient Undergoing Radical Cystectomy, Undecided on Diversion: Open or Robotic?"  The patient case was as follows: a 63-year-old journalist with a BMI of 29, who presented with hematuria and irritative symptoms. His hemoglobin was 13.5 gr/L, with a GFR of 75; ultrasonography revealed a 4.5 cm bladder tumor on the right lateral wall, which was confirmed on CT scan. There was no visible extravesical disease and no hydronephrosis. A complete TURBT was performed, as well as several additional biopsies of the bladder – pathology revealed cT2 high-grade urothelial carcinoma and carcinoma in situ on the posterior wall. A biopsy of the prostatic urethra was negative and a radical cystectomy was proposed after receiving gemcitabine/cisplatin neoadjuvant chemotherapy.

Dr. Seth Lerner took the opinion that an open radical cystectomy is the most appropriate approach for this patient. He notes that the prostatic urethral biopsy is important as it is the most sensitive method for detecting CIS in the apical urethra/prostatic ducts; a negative biopsy minimizes the risk of positive apical urethral margin. Furthermore, he is a good candidate for a neobladder given that he is young, has a negative prostatic urethral biopsy, and clinically organ-confined disease.

According to Dr. Lerner, there are several reasons why open radical cystectomy is better:

1. A neobladder is a highly complex operation requiring lots of experience
2. There is no benefit to robotic-assisted radical cystectomy with regards to morbidity based off of several studies
3. The oncologic outcomes for robotic-assisted radical cystectomy are still to be determined given that there have been several unusual patterns of recurrence
4. Robotic-assisted radical cystectomy cannot compete with the cost
5. Comparative studies have only identified estimated blood loss as a discriminator for robotic-assisted radical cystectomy

Dr. Lerner notes that when he does an open radical cystectomy he does an extended lymphadenectomy, including the pre-sacral, common iliac and aorta/IVC nodes. This increases the nodal count by 34-40% and 36-43% of patients with N+ disease have nodal metastases above the common iliac bifurcation. 

Dr. Lerner then described the Memorial Sloan Kettering randomized trial with the primary aim to determine if robotic-assisted radical cystectomy could substantially reduce the morbidity of open radical cystectomy 1. He notes this trial was powered to detect ≥20% reduction in grade II-V 90-day complications; furthermore, the authors assessed whether robotic-assisted radical cystectomy can shorten the length of stay and improve quality of life. Ultimately, this trial was stopped at the planned interim analysis for futility. 

Advocates of robotic-assisted radical cystectomy claim that the high complication rates of open radical cystectomy result in extra cost, according to Dr. Lerner, which may be offset by lower morbidity with a robotic approach. However, he notes that in a recently published cost-effectiveness study, in a 90-day model the cost of robotic-assisted radical cystectomy was €3,761 greater than open radical cystectomy 2. Cost savings for robotic-assisted radical cystectomy was only possible if the OR time was <175 minutes, length of stay was ≤4 days, or there was a reduction in equipment cost threshold to ≤ €281.

Dr. Lerner notes that the RAZOR randomized trial was a 15 center multi-center non-inferiority trial with a primary endpoint of 2-year PFS 3. The estimate was that 2-year PFS would be 70% in the open radical cystectomy arm and non-inferiority margin for robotic-assisted radical cystectomy would be ≤15%. According to Dr. Lerner, although this trial proved that robotic-assisted radical cystectomy was non-inferior to open radical cystectomy it is important to note that it was not designed to assess superiority or equivalence of robotic-assisted radical cystectomy to open radical cystectomy.

Dr. Lerner concluded with several take-home messages defending his stance of open radical cystectomy:
  • The open surgical principles are well established
  • Robotic-assisted radical cystectomy is a highly complex operation requiring experience and is not associated with as significant reduction in morbidity (only reduction in EBL)
  • Robotic-assisted radical cystectomy is associated with higher financial cost and oncologic equivalence is not established – only non-inferior 2-year PFS

Presented by:
Juan Palou, MD, Ph.D., FEBU, University Autonoma of Barcelona, Barcelona, Spain
Seth Lerner, Baylor University, Houston, Texas

Written by: Zachary Klaassen, MD, MSc – Assistant Professor of Urology, Georgia Cancer Center, Augusta University - Medical College of Georgia, Twitter: @zklaassen_md at the 34th European Association of Urology (EAU 2019) #EAU19 conference in Barcelona, Spain, March 15-19, 2019.

1. Bochner BH, Dalbagni G, Sjoberg DD, et al. Comparing Open Radical Cystectomy and Robot-assisted Laparoscopic Radical Cystectomy: A Randomized Clinical Trial. Eur Urol 2015;67(6):1042-1050.
2. Michels CTJ, Wijburg CJ, Leijte E, et al. A cost-effectiveness modeling study of robot-assisted (RARC) versus open radical cystectomy (ORC) for bladder cancer to inform future research. Eur Urol Focus. 2018 May 18 [Epub ahead of print]. 
3. 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 2018 Jun 23;391(10139):2525-2536.

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Healthy Male Patient Undergoing Radical Cystectomy, Undecided on Diversion: Robotic