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Top Line: Is radical cystectomy (RC) superior to intravesical BCG for patients with high-grade, non-muscle invasive bladder cancer (NMIBC)?

The Study: There are no randomized trials directly comparing BCG and RC for NMIBC, and accrual to trials comparing non-surgical treatment to a radical surgery is difficult. BRAVO was a randomized, phase 3 trial designed to assess the feasibility of conducting a larger randomized trial comparing BCG and RC. So, it’s important to know that BRAVO doesn’t tell us whether BCG or RC are superior, but it does tell us a lot about factors influencing treatment choice. Eligible patients had high-grade, non-muscle invasive bladder cancer (HG-NMIBC, pTa, pTis, or pT1) and at least one other adverse risk factor. The authors estimated that across 7 UK centers they would need to find 200 eligible patients per year and have 25% agree to randomization in order to complete a phase 3 comparison. Just over half of patients screened were eligible, and among those 27.6% agreed to be randomly assigned to treatment. The most common reasons for declining enrollment were preference for BCG (50%), preference for RC (25%), and dislike of random treatment assignment (18%). So was RC overkill? Among patients who had RC, 10% had muscle invasive disease, 65% had residual NMIBC, and 25% had no disease. While most patients in the BCG arm remained free of disease and with bladders intact, 9% developed distant metastasis during follow-up.

TBL: A definitive comparison of intravesical BCG and RC for high-grade, NMIBC would be a challenging endeavor, and it remains uncertain if RC is superior to BCG in this population. | Catto, J Clin Oncol 2020