MP63-04: One year oncological outcome updated analysis of a single-center prospective, randomized, controlled, non-inferiority trial: En bloc vs. conventional transurethral resection of bladder tumor
Introduction: Several randomized controlled trials (RCTs) comparing en-bloc resection of bladder tumor (ERBT) versus conventional transurethral resection of bladder tumor (cTURBT) were published showing controversial results. In particular, 1-yr recurrence rate ranged from 5-40% and 11-31% for ERBT and cTURBT, respectively. We provide an updated analysis of an RCT comparing the oncological outcome of ERBT vs. cTURBT at 1-yr follow-up (FU). Methods: This is an updated analysis of a single-center prospective, randomized, controlled, non-inferiority trial analyzing patients subjected to ERBT vs cTURBT for BC. Inclusion criteria were: tumor size of =3 cm, and =3 lesions, and no sign of muscle invasion and/or ureteral involvement. The trial (NCT04712201) was approved by the Institutional Review Board (2017/09c). Kaplan-Meier (KM) curves were used to illustrate recurrence-free survival. Log-rank test was used to assess univariable differences in recurrence-free survival/technique. Results: From April 2018 to June 2021, 248 patients were assessed for eligibility. After excluding patients diagnosed with cT0/cT2/benign/variant histology (n=11/11/5/2), we relied on a cohort of 219 patients: 123 (56.2%) and 96 (43.8%) in the ERBT and cTURBT group. Patients presenting with low-grade (LG), high-grade (HG), and CIS were 70 (56.9%), 49 (39.8%), and 4 (3.3%) vs 56 (58.3%), 37 (38.5%), and 3 (3.1%) for ERBT versus cTURBT, respectively. 201 patients reached 1-yr FU. The median FU of patients without recurrence was 19mo (IQR 14-35). Bladder 1-yr recurrence was recorded in 11 (8.9%) cases in the ERBT group (5LG; 6HG) and 12 (12.5%) cases after cTURBT (5LG; 6HG), respectively. Median time to recurrence was 14mo (IQR 8-22). The KM curve revealed that recurrence-free survival was similar between groups, as well as for LG/HG separately (p= 0.88, 0.85, 0.98; Fig.1). Conclusions: No statistical difference was found in the comparison of recurrence rates between ERBT and cTURBT at 1-yr FU. Compared to other RCTs the heterogeneity in terms of bladder recurrence may be explained by the scarce and heterogenous adoption of tools and techniques proved to lower the recurrence rate of NMIBC, supporting the implementation of a TURBT-checklist. SOURCE OF Funding: -
