BRAVO-Feasibility Study Underscores the Challenges of a Trial Comparing BCG Versus Radical Cystectomy in High-Risk Nonmuscle Invasive Bladder Cancer

2021 ◽  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Radical Cystectomy ◽  
Feasibility Study ◽  
Invasive Bladder Cancer ◽  
Nonmuscle Invasive Bladder Cancer

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

2020 ◽  
pp. JCO.20.01665
Author(s):  
James W. F. Catto ◽  
Kathryn Gordon ◽  
Michelle Collinson ◽  
Heather Poad ◽  
Maureen Twiddy ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Radical Cystectomy ◽  
Controlled Trial ◽  
Invasive Bladder Cancer ◽  
High Grade ◽  
Bacillus Calmette Guerin ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Nonmuscle Invasive Bladder Cancer

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.

scholarly journals Radical cystectomy (bladder removal) against intravesical BCG immunotherapy for high-risk non-muscle invasive bladder cancer (BRAVO): a protocol for a randomised controlled feasibility study

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017913 ◽  
Author(s):  
Jamie B Oughton ◽  
Heather Poad ◽  
Maureen Twiddy ◽  
Michelle Collinson ◽  
Victoria Hiley ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Radical Cystectomy ◽  
Feasibility Study ◽  
Phase Iii ◽  
Invasive Bladder Cancer ◽  
Muscle Invasive Bladder Cancer ◽  
Phase Iii Trial ◽  
Muscle Invasive ◽  
Randomised Controlled

IntroductionHigh-risk non-muscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease that can be difficult to predict. While around 25% of cancers progress to invasion and metastases, the remaining majority of tumours remain within the bladder. It is uncertain whether patients with HRNMIBC are better treated with intravesical maintenance BCG (mBCG) immunotherapy or primary radical cystectomy (RC). A definitive randomised controlled trial (RCT) is needed to compare these two different treatments but may be difficult to recruit to and has not been attempted to date. Before undertaking such an RCT, it is important to understand whether such a comparison is possible and how best to achieve it.Methods and analysisBRAVO is a multi-centre, parallel-group, mixed-methods, individually randomised, controlled, feasibility study for patients with HRNMIBC. Participants will be randomised to receive either mBCG immunotherapy or RC. The primary objective is to assess the feasibility and acceptability of performing the definitive phase III trial via estimation of eligibility and recruitment rates, assessing uptake of allocated treatment and compliance with mBCG, determining quality-of-life questionnaire completion rates and exploring reasons expressed by patients for declining recruitment into the study. We aim to recruit 60 participants from six centres in the UK. Surgical trials with disparate treatment options find recruitment challenging from both the patient and clinician perspective. By building on the experiences of other similar trials through implementing a comprehensive training package aimed at clinicians to address these challenges (qualitative substudy), we hope that we can demonstrate that a phase III trial is feasible.Ethics and disseminationThe study has ethical approval (16/YH/0268). Findings will be made available to patients, clinicians, the funders and the National Health Service through traditional publishing and social media.Trial registration numberISRCTN12509361; Pre results.

scholarly journals The long-term outcome of treated high-risk nonmuscle-invasive bladder cancer

Cancer ◽  
2012 ◽  
Vol 118 (22) ◽  
pp. 5525-5534 ◽  
Author(s):  
Francis Thomas ◽  
Derek J. Rosario ◽  
Naomi Rubin ◽  
John R. Goepel ◽  
Maysam F. Abbod ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Invasive Bladder Cancer ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Nonmuscle Invasive Bladder Cancer

High-risk nonmuscle invasive bladder cancer

2012 ◽  
Vol 22 (5) ◽  
pp. 385-389 ◽  
Author(s):  
Sima P. Porten ◽  
Matthew R. Cooperberg
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Invasive Bladder Cancer ◽  
Nonmuscle Invasive Bladder Cancer

POD-09.06: Radical cystectomy in nonmuscle invasive bladder cancer

Urology ◽  
2007 ◽  
Vol 70 (3) ◽  
pp. 29-30
Author(s):  
S.A. El Abd ◽  
A.R. Ramadan ◽  
M.D. El-Sharaby ◽  
M.A. El-Gharbawy
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Invasive Bladder Cancer ◽  
Nonmuscle Invasive Bladder Cancer

Phase 2 Study of Adjuvant Intravesical Instillations of Apaziquone for High Risk Nonmuscle Invasive Bladder Cancer

2012 ◽  
Vol 187 (4) ◽  
pp. 1195-1199 ◽  
Author(s):  
K. Hendricksen ◽  
E.B. Cornel ◽  
T.M. de Reijke ◽  
H.C. Arentsen ◽  
S. Chawla ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Invasive Bladder Cancer ◽  
Phase 2 ◽  
Phase 2 Study ◽  
Intravesical Instillations ◽  
Nonmuscle Invasive Bladder Cancer
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