Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study

Abstract

PURPOSE High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance Bacillus Calmette-Guerin (mBCG) and radical cystectomy (RC). We wanted to understand whether a randomized trial comparing these options was possible. MATERIALS AND METHODS We conducted a two-arm, prospective multicenter randomized study to determine the feasibility in Bacillus Calmette-Guerin-naive patients. Participants had new high-risk HRNMIBC suitable for both treatments. Random assignment was stratified by age, sex, center, stage, presence of carcinoma in situ, and prior low-risk bladder cancer. Qualitative work investigated how to maintain equipoise. The primary outcome was the number of patients screened, eligible, recruited, and randomly assigned. RESULTS We screened 407 patients, approached 185, and obtained consent from 51 (27.6%) patients. Of these, one did not proceed and therefore 50 were randomly assigned (1:1). In the mBCG arm, 23/25 (92.0%) patients received mBCG, four had nonmuscle invasive bladder cancer (NMIBC) after induction, three had NMIBC at 4 months, and four received RC. At closure, two patients had metastatic BC. In the RC arm, 20 (80.0%) participants received cystectomy, including five (25.0%) with no tumor, 13 (65.0%) with HRNMIBC, and two (10.0%) with muscle invasion in their specimen. At follow-up, all patients in the RC arm were free of disease. Adverse events were mostly mild and equally distributed (15/23 [65.2%] patients with mBCG and 13/20 [65.0%] patients with RC). The quality of life (QOL) of both arms was broadly similar at 12 months. CONCLUSION A randomized controlled trial comparing mBCG and RC will be challenging to recruit into. Around 10% of patients with high-risk HRNMIBC have a lethal disease and may be better treated by primary radical treatment. Conversely, many are suitable for bladder preservation and may maintain their prediagnosis QOL.

Clinical Outcomes and Prognosis Analysis of Younger Bladder Cancer Patients

“…However, the survival data of adjuvant treatment with an immune checkpoint inhibitor in NMIBC are still unknown. Catto et al performed a randomized controlled trial that showed that patients with high-risk NMIBC would have more clinical benefits after radical cystectomy compared with the TURB plus BCG group [ 11 ]. In our study, the 10-year CSS rate of included patients was 92.24%.…”

Bacteria−Based Synergistic Therapy in the Backdrop of Synthetic Biology

“…The adverse reactions in both groups were mild [15/23 (65.2%) BCG vs 13/20 (65.0%) RC] with similar quality of life. The results showed that a considerable number of patients were suitable for bladder preservation and could contribute to health and quality of life ( 104 ).…”

Case of the month from the University of Sheffield, UK: Expediting definitive treatment in patients with invasive bladder cancer: an MRI‐guided pathway

“…This may reflect the biology of the disease, healthcare behaviour of the at risk population [5] or that treatment improvements are needed. With regards to the latter, current pathways for BC patients can be slow and fail to discriminate between nonmuscle invasive (NMIBC) and muscle-invasive cancers (MIBC) [6,7]. For patients with MIBC, guidelines recommend that RC should not be delayed for longer than 12 weeks (84 days), as longer delays have significant impact on survival [8].…”