dc.contributor.author | Kelly, JD | |
dc.contributor.author | Tan, WS | |
dc.contributor.author | Porta, N | |
dc.contributor.author | Mostafid, H | |
dc.contributor.author | Huddart, R | |
dc.contributor.author | Protheroe, A | |
dc.contributor.author | Bogle, R | |
dc.contributor.author | Blazeby, J | |
dc.contributor.author | Palmer, A | |
dc.contributor.author | Cresswell, J | |
dc.contributor.author | Johnson, M | |
dc.contributor.author | Brough, R | |
dc.contributor.author | Madaan, S | |
dc.contributor.author | Andrews, S | |
dc.contributor.author | Cruickshank, C | |
dc.contributor.author | Burnett, S | |
dc.contributor.author | Maynard, L | |
dc.contributor.author | Hall, E | |
dc.contributor.author | BOXIT Investigators, | |
dc.date.accessioned | 2018-11-07T10:06:55Z | |
dc.date.accessioned | 2020-02-14T12:14:54Z | |
dc.date.issued | 2019-04-01 | |
dc.identifier.citation | European urology, 2019, 75 (4), pp. 593 - 601 | |
dc.identifier.issn | 0302-2838 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3510 | |
dc.identifier.eissn | 1873-7560 | |
dc.identifier.doi | 10.1016/j.eururo.2018.09.020 | |
dc.description.abstract | BACKGROUND: 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.format | Print-Electronic | |
dc.format.extent | 593 - 601 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCIENCE BV | |
dc.relation.replaces | https://repository.icr.ac.uk/handle/internal/2917 | |
dc.relation.replaces | internal/2917 | |
dc.relation.replaces | internal/2894 | |
dc.relation.replaces | https://repository.icr.ac.uk/handle/internal/2894 | |
dc.rights.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | BOXIT Investigators | |
dc.subject | Humans | |
dc.subject | Carcinoma, Transitional Cell | |
dc.subject | Neoplasm Recurrence, Local | |
dc.subject | Cardiovascular Diseases | |
dc.subject | Disease Progression | |
dc.subject | Mitomycin | |
dc.subject | Antibiotics, Antineoplastic | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | BCG Vaccine | |
dc.subject | Neoplasm Staging | |
dc.subject | Treatment Outcome | |
dc.subject | Administration, Intravesical | |
dc.subject | Risk Assessment | |
dc.subject | Risk Factors | |
dc.subject | Double-Blind Method | |
dc.subject | Time Factors | |
dc.subject | Quality of Life | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Cyclooxygenase 2 Inhibitors | |
dc.subject | Urinary Bladder Neoplasms | |
dc.subject | Celecoxib | |
dc.subject | United Kingdom | |
dc.title | BOXIT-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.type | Journal Article | |
dcterms.dateAccepted | 2018-09-11 | |
rioxxterms.versionofrecord | 10.1016/j.eururo.2018.09.020 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2019-04 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European urology | |
pubs.issue | 4 | |
pubs.notes | Not 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-status | Published | |
pubs.volume | 75 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Clinical Trials & Statistics Unit | |
icr.researchteam | ICR-CTSU Urology and Head and Neck Trials Team | |
icr.researchteam | Clinical Academic Radiotherapy (Huddart) | |
dc.contributor.icrauthor | Porta, Nuria | |
dc.contributor.icrauthor | Huddart, Robert | |
dc.contributor.icrauthor | Cruickshank, Clare | |
dc.contributor.icrauthor | Burnett, Stephanie | |
dc.contributor.icrauthor | Hall, Emma | |