Evidence map›Paper›PMID 33332191›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

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

James W F Catto, Kathryn Gordon, Michelle Collinson, Heather Poad, Maureen Twiddy, Mark Johnson, Sunjay Jain, Rohit Chahal, Matt Simms, Mohantha Dooldeniya and 8 more

Open access · hybridAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 2 pooled it
11.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 2 syntheses or guidelines pooled it, 114 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. TAR-200 for Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  4. Trial
  5. Trial
  6. Image directed redesign of bladder cancer treatment pathways: the BladderPath RCT.Health technology assessment (Winchester, England) · 2024
    Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Observational
  18. Article
  19. Article
  20. Article

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 1 country.

James W F CattoAcademic Urology Unit, University of Sheffield, Sheffield, United Kingdom.
Kathryn GordonClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.
Michelle CollinsonClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.
Heather PoadClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.
Maureen TwiddyInstitute of Clinical and Applied Health Research, University of Hull, Hull, United Kingdom.
Mark JohnsonFreeman Hospital, Newcastle, United Kingdom.
Sunjay JainSt James's University Hospital, Leeds, United Kingdom.
Rohit ChahalBradford Teaching Hospitals NHS Foundation Trust, Bradford, United Kingdom.
Matt SimmsHull and East Yorkshire NHS Trust, Hull, United Kingdom.
Mohantha DooldeniyaMid Yorkshire Hospitals NHS Trust, Wakefield, United Kingdom.
Richard BellChurchill Hospital, Oxford University Hospitals NHS Trust, Oxford, United Kingdom.
Phillip KoenigAiredale NHS Foundation Trust, Keighley, United Kingdom.
Samantha ConroyAcademic Urology Unit, University of Sheffield, Sheffield, United Kingdom.
Louise GoodwinAcademic Urology Unit, University of Sheffield, Sheffield, United Kingdom.
Aidan P NoonDepartment of Urology, Royal Hallamshire Hospital, Sheffield, United Kingdom.
Julie CroftClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.
Julia M BrownClinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, United Kingdom.
BRAVO study group
University of Leeds · GBUniversity of Sheffield · GBAiredale NHS Foundation Trust · GBBradford Teaching Hospitals NHS Foundation Trust · GBChurchill Hospital · GBFreeman Hospital · GBHull and East Yorkshire Hospitals NHS Trust · GBMid Yorkshire Hospitals NHS Trust · GBRoyal Hallamshire Hospital · GBSt James's University Hospital · GBUniversity of Hull · GB

Funding

Department of Health NIHR300047
6 · The paper itself

Abstract

purposeHigh-grade nonmuscle invasive bladder cancer (HRNMIBC) is a heterogeneous disease. Treatments include intravesical maintenance MATERIALS AND

methodsWe conducted a two-arm, prospective multicenter randomized study to determine the feasibility in

resultsWe 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.

conclusionA 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.

Indexed as

CystectomyAdministration, IntravesicalAntineoplastic AgentsBCG VaccineFeasibility StudiesFemaleHumansMaleNeoplasm GradingNeoplasm InvasivenessProspective StudiesTime FactorsTreatment OutcomeUnited KingdomUrinary Bladder NeoplasmsAntineoplastic AgentsBCG Vaccine

Identifiers

PMID33332191
PMCPMC8078404
OpenAlexW3113334560

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.