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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

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., …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
Print ISSN 0732-183X
Electronic ISSN 1527-7755
Publisher American Society of Clinical Oncology
Peer Reviewed Peer Reviewed
Volume 39
Issue 3
Pages 202-214
DOI https://doi.org/10.1200/JCO.20.01665
Public URL https://hull-repository.worktribe.com/output/3711113

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