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

Overview

Journal J Clin Oncol

Specialty Oncology

Date 2020 Dec 17

PMID 33332191

Citations 38

Authors

James W F Catto

Kathryn Gordon

Michelle Collinson

Heather Poad

Maureen Twiddy

Mark Johnson

Sunjay Jain

Rohit Chahal

Matt Simms

Mohantha Dooldeniya

Richard Bell

Phillip Koenig

Samantha Conroy

Louise Goodwin

Aidan P Noon

Julie Croft

Julia M Brown

Affiliations

Soon will be listed here.

Abstract

Purpose: High-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance (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 -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.

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