Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study
Brown, Julia M.; Croft, Julie; Poad, Heather; Bell, Richard; Collinson, Michelle; Gordon, Kathryn; Dooldeniya, Mohantha; Conroy, Samantha; Catto, James W.F.; Noon, Aidan P.; Simms, Matt; Chahal, Rohit; Jain, Sunjay; Koenig, Phillip; Johnson, Mark; Twiddy, Maureen; Goodwin, Louise
Authors
Julia M. Brown
Julie Croft
Heather Poad
Richard Bell
Michelle Collinson
Kathryn Gordon
Mohantha Dooldeniya
Samantha Conroy
James W.F. Catto
Aidan P. Noon
Matt Simms
Rohit Chahal
Sunjay Jain
Phillip Koenig
Mark Johnson
Dr Maureen Twiddy M.Twiddy@hull.ac.uk
Reader in Mixed Methods Research
Louise Goodwin
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.
Citation
Brown, J. M., Croft, J., Poad, H., Bell, R., Collinson, M., Gordon, K., Dooldeniya, M., Conroy, S., Catto, J. W., Noon, A. P., Simms, M., Chahal, R., Jain, S., Koenig, P., Johnson, M., Twiddy, M., & Goodwin, L. (2021). Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study. Journal of Clinical Oncology, 39(3), 202-214. https://doi.org/10.1200/JCO.20.01665
Journal Article Type
Article
Acceptance Date
Oct 28, 2020
Publication Date
Jan 20, 2021
Deposit Date
Apr 22, 2021
Publicly Available Date
Apr 22, 2021
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
