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dc.contributor.authorKelly, JD
dc.contributor.authorTan, WS
dc.contributor.authorPorta, N
dc.contributor.authorMostafid, H
dc.contributor.authorHuddart, R
dc.contributor.authorProtheroe, A
dc.contributor.authorBogle, R
dc.contributor.authorBlazeby, J
dc.contributor.authorPalmer, A
dc.contributor.authorCresswell, J
dc.contributor.authorJohnson, M
dc.contributor.authorBrough, R
dc.contributor.authorMadaan, S
dc.contributor.authorAndrews, S
dc.contributor.authorCruickshank, C
dc.contributor.authorBurnett, S
dc.contributor.authorMaynard, L
dc.contributor.authorHall, E
dc.contributor.authorBOXIT Investigators
dc.date.accessioned2018-11-07T10:06:55Z
dc.date.accessioned2020-02-14T12:14:54Z
dc.date.issued2019-04
dc.identifier.citationEuropean urology, 2019, 75 (4), pp. 593 - 601
dc.identifier.issn0302-2838
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3510
dc.identifier.eissn1873-7560
dc.identifier.doi10.1016/j.eururo.2018.09.020
dc.description.abstractBackground Non-muscle-invasive bladder cancer (NMIBC) has a significant risk of recurrence despite adjuvant intravesical therapy.Objective To determine whether celecoxib, a cyclo-oxygenase 2 inhibitor, reduces the risk of recurrence in NMIBC patients receiving standard treatment.Design, setting, and participants BOXIT (CRUK/07/004, ISRCTN84681538) is a double-blinded, phase III, randomised controlled trial. Patients aged ≥18 yr with intermediate- or high-risk NMIBC were accrued across 51 UK centres between 1 November 2007 and 23 July 2012.Intervention Patients were randomised (1:1) to celecoxib 200mg twice daily or placebo for 2 yr. Patients with intermediate-risk NMIBC were recommended to receive six weekly mitomycin C instillations; high-risk NMIBC cases received six weekly bacillus Calmette-Guérin and maintenance therapy.Outcome measurements and statistical analysis The primary endpoint was time to disease recurrence. Analysis was by intention to treat.Results and limitations A total of 472 patients were randomised (236:236). With median follow-up of 44 mo (interquartile range: 36-57), 3-yr recurrence-free rate (95% confidence interval) was as follows: celecoxib 68% (61-74%) versus placebo 64% (57-70%; hazard ratio [HR] 0.82 [0.60-1.12], p=0.2). There was no difference in high-risk (HR 0.77 [0.52-1.15], p=0.2) or intermediate-risk (HR 0.90 [0.55-1.48], p=0.7) NMIBC. Subgroup analysis suggested that time to recurrence was longer in pT1 NMIBC patients treated with celecoxib compared with those receiving placebo (HR 0.53 [0.30-0.94], interaction test p=0.04). The 3-yr progression rates in high-risk patients were low: 10% (6.5-17%) and 9.7% (6.0-15%) in celecoxib and placebo arms, respectively. Incidence of serious cardiovascular events was higher in celecoxib (5.2%) than in placebo (1.7%) group (difference +3.4% [-0.3% to 7.2%], p=0.07).Conclusions BOXIT did not show that celecoxib reduces the risk of recurrence in intermediate- or high-risk NMIBC, although celecoxib was associated with delayed time to recurrence in pT1 NMIBC patients. The increased risk of cardiovascular events does not support the use of celecoxib.Patient summary Celecoxib was not shown to reduce the risk of recurrence in intermediate- or high-risk non-muscle-invasive bladder cancer (NMIBC), although celecoxib was associated with delayed time to recurrence in pT1 NMIBC patients. The increased risk of cardiovascular events does not support the use of celecoxib.
dc.formatPrint-Electronic
dc.format.extent593 - 601
dc.languageeng
dc.language.isoeng
dc.relation.replaceshttps://repository.icr.ac.uk/handle/internal/2917
dc.relation.replacesinternal/2917
dc.relation.replacesinternal/2894
dc.relation.replaceshttps://repository.icr.ac.uk/handle/internal/2894
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved
dc.subjectBOXIT Investigators
dc.subjectHumans
dc.subjectCarcinoma, Transitional Cell
dc.subjectNeoplasm Recurrence, Local
dc.subjectCardiovascular Diseases
dc.subjectDisease Progression
dc.subjectMitomycin
dc.subjectAntibiotics, Antineoplastic
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectBCG Vaccine
dc.subjectNeoplasm Staging
dc.subjectTreatment Outcome
dc.subjectAdministration, Intravesical
dc.subjectRisk Assessment
dc.subjectRisk Factors
dc.subjectDouble-Blind Method
dc.subjectTime Factors
dc.subjectQuality of Life
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectCyclooxygenase 2 Inhibitors
dc.subjectUrinary Bladder Neoplasms
dc.subjectCelecoxib
dc.subjectUnited Kingdom
dc.titleBOXIT-A Randomised Phase III Placebo-controlled Trial Evaluating the Addition of Celecoxib to Standard Treatment of Transitional Cell Carcinoma of the Bladder (CRUK/07/004).
dc.typeJournal Article
dcterms.dateAccepted2018-09-11
rioxxterms.versionofrecord10.1016/j.eururo.2018.09.020
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2019-04
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfEuropean urology
pubs.issue4
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Clinical Trials & Statistics Unit
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/ICR-CTSU Urology and Head and Neck Trials Team
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Clinical Academic Radiotherapy (Huddart)
pubs.publication-statusPublished
pubs.volume75
pubs.embargo.termsNot known
icr.researchteamClinical Trials & Statistics Uniten_US
icr.researchteamICR-CTSU Urology and Head and Neck Trials Teamen_US
icr.researchteamClinical Academic Radiotherapy (Huddart)en_US
dc.contributor.icrauthorHall, Emmaen
dc.contributor.icrauthorPorta, Nuriaen
dc.contributor.icrauthorHuddart, Roberten
dc.contributor.icrauthorCruickshank, Clareen
dc.contributor.icrauthorBurnett, Stephanieen


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