Evidence map›Paper›PMID 32124514›Full record

Trial reportBJU international2020

CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.

A Hugh Mostafid, Nuria Porta, Joanne Cresswell, Thomas R L Griffiths, John D Kelly, Steven R Penegar, Kim Davenport, John S McGrath, Nicholas Campain, Peter Cooke and 7 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BJU international, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02070120 (CALIBER - A Phase II Randomised Feasibility Study of Chemoresection and Surgical Management in Low Risk Non Muscle Invasive Bladder Cancer), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
5.7field-weighted citation impact, top 3% 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.

NCT02070120 phase2unknown statusnot on this map

CALIBER - A Phase II Randomised Feasibility Study of Chemoresection and Surgical Management in Low Risk Non Muscle Invasive Bladder Cancer

TypeinterventionalSponsorInstitute of Cancer Research, United KingdomRan2014 to 2020Enrolled82ConditionsBladder CancerArmsMitomycin C, Surgical Management
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
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  6. Article
  7. Advances in the management of localized bladder cancers.Nature reviews. Clinical oncology · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 12 institutions in 1 country.

A Hugh MostafidRoyal Surrey County Hospital NHS Foundation Trust, Guildford, UK.ORCID 0000-0002-5095-2929
Nuria PortaInstitute of Cancer Research, London, UK.
Joanne CresswellSouth Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
Thomas R L GriffithsUniversity Hospitals of Leicester NHS Trust, Leicester, UK.
John D KellyUniversity College London, London, UK.
Steven R PenegarInstitute of Cancer Research, London, UK.
Kim DavenportGloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.
John S McGrathRoyal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Nicholas CampainRoyal Devon and Exeter NHS Foundation Trust, Exeter, UK.
Peter CookeRoyal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.
Shikohe MasoodMedway NHS Foundation Trust, Gillingham, UK.
Margaret A KnowlesUniversity of Leeds, Leeds, UK.
Andrew FeberUniversity College London, London, UK.
Allen KnightAction Bladder Cancer UK, Gloucestershire, UK.
James W F CattoUniversity of Sheffield, Sheffield, UK.
Rebecca LewisInstitute of Cancer Research, London, UK.
Emma HallInstitute of Cancer Research, London, UK.ORCID 0000-0001-5999-5020
Institute of Cancer Research · GBRoyal Devon & Exeter NHS Foundation Trust · GBUniversity College London · GBAction Cancer · GBGloucestershire Hospitals NHS Foundation Trust · GBMedway NHS Foundation Trust · GBRoyal Surrey County Hospital · GBSouth Tees Hospitals NHS Foundation Trust · GBThe Royal Wolverhampton NHS Trust · GBUniversity Hospitals of Leicester NHS Trust · GBUniversity of Leeds · GBUniversity of Sheffield · GB

Funding

Cancer Research UK 25351Cancer Research UK C1491/A15955Cancer Research UK C1491/A25351Department of Health PB-PG-0712-28112
6 · The paper itself

Abstract

objectivesTo evaluate the activity of intravesical mitomycin-C (MMC) to ablate recurrent low-risk non-muscle-invasive bladder cancer (NMIBC) and assess whether it may enable patients to avoid surgical intervention for treatment of recurrence. PATIENTS AND

methodsCALIBER is a phase II feasibility study. Participants were randomized (2:1) to treatment with four once-weekly MMC 40-mg intravesical instillations (chemoablation arm) or to surgical management. The surgical group was included to assess the feasibility of randomization. The primary endpoint was complete response to intravesical MMC in the chemoablation arm at 3 months, reported with exact 95% confidence intervals (CIs). Secondary endpoints included time to subsequent recurrence, summarized by Kaplan-Meier methods.

resultsBetween February 2015 and August 2017, 82 patients with visual diagnosis of recurrent low-risk NMIBC were enrolled from 24 UK hospitals (chemoablation, n = 54; surgical management, n =28). The median follow-up was 24 months. Complete response at 3 months was 37.0% (20/54; 95% CI 24.3-51.3) with chemoablation and 80.8% (21/26; 95% CI 60.6-93.4) with surgical management. Amongst patients with complete response at 3 months, a similar proportion was recurrence-free by 12 months in both groups (84%). Amongst those with residual disease at 3 months, the 12-month recurrence-free proportion was lower in the surgical management group (40.0%) than in the chemoablation group (84%). Recruitment stopped early as chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months.

conclusionIntravesical chemoablation in low-risk NMIBC is feasible and safe, but did not demonstrate sufficient response in the present trial. After chemoablation there may be a reduction in recurrence rate, even in non-responders, that is greater than with surgery alone. Further research is required to investigate the role and optimal schedule of neoadjuvant intravesical chemotherapy prior to surgery for NMIBC.

Indexed as

Antibiotics, AntineoplasticMitomycinUrinary Bladder NeoplasmsAdministration, IntravesicalAgedAged, 80 and overFeasibility StudiesFemaleHumansMaleMiddle AgedQuality of LifeAntibiotics, AntineoplasticMitomycin#BladderCancer#blcsmchemoablationmitomycin-Cnon-muscle-invasive bladder cancerrandomized trialsurgery

Identifiers

PMID32124514
PMCPMC7318672
OpenAlexW3009352659

What OpenQuestion holds

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Registered trials

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.