Associate Professor The Chinese University of Hong Kong
Introduction: Conventionally, standard resection (SR) is performed by resecting the bladder tumor in a piecemeal manner. En bloc resection of bladder tumor (ERBT) has been proposed as a potentially superior technique in treating non-muscle-invasive bladder cancer (NMIBC). Methods: The EB-StaR study is a multi-centre, randomized, phase 3 trial comparing between ERBT and SR. In this study, we randomly assigned patients with bladder tumor(s) of =3cm to receive ERBT or SR. The primary outcome was 1-year recurrence rate. A modified intention-to-treat analysis on patients with histologically confirmed NMIBC was performed for the study outcomes. This trial is registered with ClinicalTrials.gov (NCT02993211). Results: From April 2017 to Dec 2020, a total of 350 patients were recruited and randomized to receive ERBT or SR. Among the 350 patients, 276 patients were histologically confirmed to have NMIBC, with 143 patients in the ERBT group and 133 patients in the SR group. Regarding the primary outcome, the 1-year recurrence rates were 28.5% (95% confidence interval, 18.4-37.4%) in the ERBT group, and 38.1% (95% confidence interval, 28.4-46.5%) in the SR group (p=0.007). The 1-year progression rates were 0% in the ERBT group, and 2.6% (95% confidence interval, 0-5.5%) in the SR group (p=0.065). The ERBT group had a longer operative time (33.4±18.5 vs 24.7±12.9 minutes, p < 0.001) than the SR group. All other secondary outcomes including the detrusor muscle sampling rates, occurrence of obturator reflex, rates of post-operative mitomycin C instillation, hospital stay, 30-day complications, residual disease and upstaging of disease upon second-look transurethral resection were similar between the two groups. Conclusions: In patients with NMIBC of =3cm, ERBT resulted in a significant reduction in 1-year recurrence rate when compared to SR. SOURCE OF Funding: Funded by GRF/ECS, Research Grants Council of Hong Kong, Reference no: 14117421, 14120620 and 24116518.
