PD52-11 HEALTH RELATED QUALITY OF LIFE OUTCOMES BY URINARY DIVERSION: AN ANALYSIS FROM THE RANDOMIZED ROBOTIC VERSUS OPEN RADICAL CYSTECTOMY (RAZOR) TRIAL

Abstract

INTRODUCTION AND OBJECTIVES: 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 Bonferroni'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.