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EAU Annual Congress 2021

EAU 2021: En-Bloc Versus Conventional Transurethral Resection of Bladder Tumors: Interim Analysis of a Single-Center Prospective Randomized Trial

(UroToday.com) At the non-muscle invasive bladder cancer (NMIBC) treatment and prognosis session at the European Association of Urology 2021 annual meeting Dr. Pietro Diana presented interim results of a single-center prospective randomized trial assessing en-bloc versus conventional transurethral resection of bladder tumors (TURBT). TURBT is considered the gold standard in the diagnosis and risk stratification of bladder cancer, however, en-bloc resection of bladder tumors has been proposed to improve resection quality. Recently, the International Collaborative Consensus Statement on en-bloc resection of bladder tumor underlined the lack of high-quality prospective studies precluding the achievement of solid conclusion for en-bloc resection1. The aim of this study was to compare TURBT and en-bloc resection of bladder tumors in terms of pathological diagnosis, surgical, and oncological outcomes.

           
This study is an ongoing, prospective, randomized trial enrolling patients diagnosed with bladder cancer and undergoing endoscopic intervention. Inclusion criteria were tumor size of < 3 cm, and ≤ 3 lesions, and no sign of muscle invasion and/or ureteral involvement. The primary outcome is bladder cancer staging, and secondary outcomes include T1 substaging (microstaging systems T1a/b/c), intraoperative complications, rate of adjuvant treatment, postoperative complications, and oncologic outcomes. A total of 300 subjects will be included in the study with 1:1.5 treatment allocation for en-bloc resection of bladder tumor. From March 2018 to January 2020, 180 patients met inclusion criteria.  An up to date flow diagram is as follows:

Diana_EAU21_figure1.png

Overall, 64 (40.5%) and 94 (59.5%) patients were submitted to TURBT and en-bloc resection of bladder tumor, respectively. Pre-operatively, the populations were comparable. T1 substaging was feasible in 80% of TURBT patients versus 100% of en-bloc resection of bladder tumor patients (p=0.07). Adjuvant treatment was planned in 84% and 94% in TURBT and en-bloc resection of bladder tumor, respectively (p=0.1). The rate of obturator nerve reflex and perforation were comparable (both p=0.3), and Clavien-Dindo >2 complications were 5.3% for TURBT patients compared to 3.1% for en-bloc resection of bladder tumor. Surgical, irrigation and catheterization time were all comparable (all p>0.2). Recurrence at 3 months was 3.1% vs 2.1% in TURBT and en-bloc resection of bladder tumor (p=0.7). The complete outcomes are as follows:

Diana_EAU21_figure2.png

Dr. Diani concluded his presentation with the following take-home messages:

  • According to the interim analysis, en-bloc resection of bladder tumor and TURBT have comparable results in terms of pathological, surgical, and oncological outcomes
  • En-bloc resection of bladder tumor shows a tendency to significance in T1 substaging feasibility
  • This is the first randomized study in this setting and it is warranted to define the role of en-bloc resection of bladder tumor

Presented By: Pietro Diana, MD, Department of Urology, Humanitas Clinical and Research Center, Rozzano, Italy

Written By: Zachary Klaassen, MD, MSc – Urologic Oncologist, Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia, @zklaassen_md on Twitter during the 2021 European Association of Urology, EAU 2021- Virtual Meeting, July 8-12, 2021.

References: 

  1. Teoh JYC, MacLennan S, Chan VWS, et al. An International Collaborative Consensus Statement on En Bloc Resection of Bladder Tumour Incorporating Two Systematic Reviews, a Two-round Delphi Survey, and a Consensus Meeting. Eur Urol 2020 Oct;78(4):546-569.