Radical cystectomy against intra-vesical BCG immunotherapy for high risk non-muscle invasive bladder cancer: Results from the randomised controlled BRAVO-feasibility study
BAUS ePoster online library. Catto J. 11/10/20; 304209; P12-6 Disclosure(s): JWFC has received reimbursement for consultancy from Astra Zeneca, Roche and Janssen, speaker fees from BMS, MSD, Nucleix and Roche, and honoraria for membership of advisory boards for Ferring, Roche and Janssen.
Prof. James Catto
Prof. James Catto
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Radical cystectomy against intra-vesical BCG immunotherapy for high risk non-muscle invasive bladder cancer: Results from the randomised controlled BRAVO-feasibility study

Catto J1, Gordon K2, Poad H2, Twiddy M3, Johnson M4, Jain S5, Chalal R6, Simms M7, Dooldeniya M8, Bell R9, Koenig P10, Conroy S1, Goodwin L1, Noon A1, Croft J2, Collinson M2, Brown J2
1Sheffield Teaching Hospitals Nhs Trust, United Kingdom, 2Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom, 3Institute of Clinical and Applied Health Research, University of Hull, UK, 4Freeman Hospital, Newcastle, UK, 5St James's University Hospital, Leeds, UK, 6Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK, 7Hull and East Yorkshire NHS Trust, UK, 8Mid Yorkshire Hospitals NHS Trust, Wakefield, UK, 9Churchill Hospital, Oxford University Hospitals NHS Trust, Uk, 10Airedale NHS Foundation Trust, Keighley, UK

Purpose: High-risk non-muscle invasive bladder cancer (NMIBC) is a heterogeneous disease. Treatments include maintenance BCG (mBCG) and Radical Cystectomy (RC).

Methods:
We conducted a prospective multicentre RCT to determine the feasibility of a phase 3 trial comparing BCG with RC in BCG naïve patients. Eligible participants had new high-risk NMIBC suitable for both treatments. The primary outcome was recruited patients.

Results:
Between October 2016 and March 2018, we approached 185 eligible patients and recruited 51 (27.5%). Of these, 1 withdrew and 25 were randomised to each of mBCG and RC. In the mBCG arm, 23/25 (92%) patient received mBCG, 4 had NMIBC at 6 weeks, 3 with NMIBC at 4 months and 4 received RC. At closure, 1 patient had metastatic BC. In the RC arm, 20 (80%) participants received surgery, including 5 (25%) with no tumour, 13 (65%) with high grade NMIBC (65%) and 2 (10%) with muscle invasion in their specimen. At closure, all patients were free of disease. Adverse events were common, mostly mild and equally distributed (13/20 (65.0%) with RC and 15/23 (65.2%) with mBCG). The quality of life of both arms was broadly similar by 12 months.

Conclusion:
An RCT comparing mBCG and RC, using survival as an endpoint, will be challenging to recruit into. Patients will agree to be randomised if clinicians are in equipoise. Around 10% of patients with high risk NMIBC have a lethal disease and may be better treated by primary radical treatment.
Radical cystectomy against intra-vesical BCG immunotherapy for high risk non-muscle invasive bladder cancer: Results from the randomised controlled BRAVO-feasibility study

Catto J1, Gordon K2, Poad H2, Twiddy M3, Johnson M4, Jain S5, Chalal R6, Simms M7, Dooldeniya M8, Bell R9, Koenig P10, Conroy S1, Goodwin L1, Noon A1, Croft J2, Collinson M2, Brown J2
1Sheffield Teaching Hospitals Nhs Trust, United Kingdom, 2Clinical Trials Research Unit, University of Leeds, Leeds, United Kingdom, 3Institute of Clinical and Applied Health Research, University of Hull, UK, 4Freeman Hospital, Newcastle, UK, 5St James's University Hospital, Leeds, UK, 6Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK, 7Hull and East Yorkshire NHS Trust, UK, 8Mid Yorkshire Hospitals NHS Trust, Wakefield, UK, 9Churchill Hospital, Oxford University Hospitals NHS Trust, Uk, 10Airedale NHS Foundation Trust, Keighley, UK

Purpose: High-risk non-muscle invasive bladder cancer (NMIBC) is a heterogeneous disease. Treatments include maintenance BCG (mBCG) and Radical Cystectomy (RC).

Methods:
We conducted a prospective multicentre RCT to determine the feasibility of a phase 3 trial comparing BCG with RC in BCG naïve patients. Eligible participants had new high-risk NMIBC suitable for both treatments. The primary outcome was recruited patients.

Results:
Between October 2016 and March 2018, we approached 185 eligible patients and recruited 51 (27.5%). Of these, 1 withdrew and 25 were randomised to each of mBCG and RC. In the mBCG arm, 23/25 (92%) patient received mBCG, 4 had NMIBC at 6 weeks, 3 with NMIBC at 4 months and 4 received RC. At closure, 1 patient had metastatic BC. In the RC arm, 20 (80%) participants received surgery, including 5 (25%) with no tumour, 13 (65%) with high grade NMIBC (65%) and 2 (10%) with muscle invasion in their specimen. At closure, all patients were free of disease. Adverse events were common, mostly mild and equally distributed (13/20 (65.0%) with RC and 15/23 (65.2%) with mBCG). The quality of life of both arms was broadly similar by 12 months.

Conclusion:
An RCT comparing mBCG and RC, using survival as an endpoint, will be challenging to recruit into. Patients will agree to be randomised if clinicians are in equipoise. Around 10% of patients with high risk NMIBC have a lethal disease and may be better treated by primary radical treatment.
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