Presentation Authors: Maria Becerra*, Vivek Venkatramani, Miami , FL, Isildinha Reis, Miami, FL, Nachiketh Soodana-Prakash, Miami , FL, Erik Castle, Phoenix, AZ, Mark Gonzalgo, Miami , FL, Michael Woods, Chapel Hill, NC, Robert Svatek, San Antonio, TX, Alon Weizer, Ann Arbor, MI, Badrinath Konety, Minneapolis, MN, Mathew Tollefson, Phoenix, AZ, Tracey Krupski, Charlottesville, VA, Norm Smith, Chicago, IL, Ahmad Shabsigh, Columbus, OH, Daniel Berocas, Nashville, TN, Marcus Quek, Maywood, IL, Atreya Dash, Seattle, WA, Adam Kibel, Boston, MA, Raj Pruthi, Chapel Hill, NC, Jeffrey Montgomery, Ann Arbor, MI, Christopher Weight, Minneapolis, MN, David Sharp, Columbus, OH, Sam Chang, Nashville, TN, Michael Cookson, Norman, OK, Gopal Gupta, Alex Gorbonos, Maywood, IL, Edward Uchio, Irvine, CA, Eila Skinner, Stanford, CA, Kerri kendrick, San Antonio, TX, Joseph Smith, Nashville, TN, Ian Thompson, San Antonio, TX, Dipen Parekh, Miami , FL
Introduction: The advantage of health-related quality of life (HRQoL) in continent (C) urinary diversions (UD) over non-continent (NC) UD remains controversial. We compared outcomes by UD type following radical cystectomy (RC) in patients from the RAZOR trial; a multicenter, open-label non-inferiority phase III randomized trial comparing robot-assisted radical cystectomy (RARC) to open cystectomy (OC).
Methods: HRQoL was evaluated using the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index (FACT-VCI) and the SF-8 [with a physical (PCS) and a mental (MCS) component scores]. All questionnaires were administered at baseline, 3- and 6- months (mo) postoperatively. All UD were extracorporeal and determined per patient and surgeon preference. For each endpoint we estimated means by arm and time and by type of diversion and time adjusted for key covariates. We report estimated means with corresponding 95% confidence interval, and p-values adjusted for multiple comparisons among estimated means using the Bonferroniâ€™s method, in the per-protocol population.
Results: Sixty-seven patients (22.2%) had CUD (24.7% and 19.7% from the RARC and OC arms, respectively) and 235 (77.8%) a NCUD (75.3% and 80.3% from the RARC and OC arms, respectively). There was no difference between UD groups at any time point for FACT-VCI scores (Table 1A). CUD group showed a significant improvement in social and emotional well-being (SWB and EWB) at 3 mo but a significant worsening of FACT Bl-Cys score. The NCUD group showed statistically significant improvement at 3- and 6-mo vs baseline in the EWB as well as in all derived scores. SF-8 scores showed an improvement in both groups after surgery (Table 1B). There was no statistically significant difference between diversion types (p>0.05) for MCS. However, for PCS there was a significant difference between diversion types at 6 mo (PCS mean 51.8 for CUD vs. 46.2 for NCUD, adjusted p=0.019).
Conclusions: Our data from the RAZOR trial shows no relevant differences between CUD and NCUD with respect to QOL at any time point up to 6 months. Future adequately powered studies will help guide personalized selection of an appropriate UD for each case.
Source of Funding: The RAZOR trial was supported by the National Institutes of Health (NIH) National Cancer Institute (NCI; grant number 5RO1CA155388).