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dc.contributor.authorHuddart, RAen_US
dc.contributor.authorBirtle, Aen_US
dc.contributor.authorMaynard, Len_US
dc.contributor.authorBeresford, Men_US
dc.contributor.authorBlazeby, Jen_US
dc.contributor.authorDonovan, Jen_US
dc.contributor.authorKelly, JDen_US
dc.contributor.authorKirkbank, Ten_US
dc.contributor.authorMcLaren, DBen_US
dc.contributor.authorMead, Gen_US
dc.contributor.authorMoynihan, Cen_US
dc.contributor.authorPersad, Ren_US
dc.contributor.authorScrase, Cen_US
dc.contributor.authorLewis, Ren_US
dc.contributor.authorHall, Een_US
dc.date.accessioned2017-05-23T15:43:01Z
dc.date.issued2017-11en_US
dc.identifier.citationBJU international, 2017, 120 (5), pp. 639 - 650en_US
dc.identifier.issn1464-4096en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/652
dc.identifier.eissn1464-410Xen_US
dc.identifier.doi10.1111/bju.13900en_US
dc.description.abstractTo test the feasibility of a randomised trial in muscle-invasive bladder cancer (MIBC) and compare outcomes in patients who receive neoadjuvant chemotherapy followed by radical cystectomy (RC) or selective bladder preservation (SBP), where definitive treatment [RC or radiotherapy (RT)] is determined by response to chemotherapy.SPARE is a multicentre randomised controlled trial comparing RC and SBP in patients with MIBC staged T2-3 N0 M0, fit for both treatment strategies and receiving three cycles of neoadjuvant chemotherapy. Patients were randomised between RC and SBP before a cystoscopy after cycle three of neoadjuvant chemotherapy. Patients with ≤T1 residual tumour received a fourth cycle of neoadjuvant chemotherapy in both groups, followed by radical RT in the SBP group and RC in in the RC group; non-responders in both groups proceeded immediately to RC following cycle three. Feasibility study primary endpoints were accrual rate and compliance with assigned treatment strategy. The phase III trial was designed to demonstrate non-inferiority of SBP in terms of overall survival (OS) in patients whose tumours responded to neoadjuvant chemotherapy. Secondary endpoints included patient-reported quality of life, clinician assessed toxicity, loco-regional recurrence-free survival, and rate of salvage RC after SBP.Trial recruitment was challenging and below the predefined target with 45 patients recruited in 30 months (25 RC; 20 SBP). Non-compliance with assigned treatment strategy was frequent, six of the 25 patients (24%) randomised to RC received RT. Long-term bladder preservation rate was 11/15 (73%) in those who received RT per protocol. OS survival was not significantly different between groups.Randomising patients with MIBC between RC and SBP based on response to neoadjuvant chemotherapy was not feasible in the UK health system. Strong clinician and patient preferences for treatments impacted willingness to undergo randomisation and acceptance of treatment allocation. Due to the few participants, firm conclusions about disease and toxicity outcomes cannot be drawn.en_US
dc.formatPrint-Electronicen_US
dc.format.extent639 - 650en_US
dc.languageengen_US
dc.language.isoengen_US
dc.subjectHumansen_US
dc.subjectTreatment Outcomeen_US
dc.subjectCystectomyen_US
dc.subjectFeasibility Studiesen_US
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectAged, 80 and overen_US
dc.subjectMiddle Ageden_US
dc.subjectFemaleen_US
dc.subjectMaleen_US
dc.subjectUrinary Bladderen_US
dc.subjectUrinary Bladder Neoplasmsen_US
dc.subjectKaplan-Meier Estimateen_US
dc.subjectOrgan Sparing Treatmentsen_US
dc.titleClinical and patient-reported outcomes of SPARE - a randomised feasibility study of selective bladder preservation versus radical cystectomy.en_US
dc.typeJournal Article
dcterms.dateAccepted2017-04-25en_US
rioxxterms.versionofrecord10.1111/bju.13900en_US
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0en_US
rioxxterms.licenseref.startdate2017-11en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfBJU internationalen_US
pubs.issue5en_US
pubs.notesNot knownen_US
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/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume120en_US
pubs.embargo.termsNot knownen_US
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_US
dc.contributor.icrauthorHuddart, Roberten_US
dc.contributor.icrauthorLewis, Rebeccaen_US
dc.contributor.icrauthorMarsden,en_US


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