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dc.contributor.authorChisholm, JCen_US
dc.contributor.authorMerks, JHMen_US
dc.contributor.authorCasanova, Men_US
dc.contributor.authorBisogno, Gen_US
dc.contributor.authorOrbach, Den_US
dc.contributor.authorGentet, J-Cen_US
dc.contributor.authorThomassin-Defachelles, A-Sen_US
dc.contributor.authorChastagner, Pen_US
dc.contributor.authorLowis, Sen_US
dc.contributor.authorRonghe, Men_US
dc.contributor.authorMcHugh, Ken_US
dc.contributor.authorvan Rijn, RRen_US
dc.contributor.authorHilton, Men_US
dc.contributor.authorBachir, Jen_US
dc.contributor.authorFürst-Recktenwald, Sen_US
dc.contributor.authorGeoerger, Ben_US
dc.contributor.authorOberlin, Oen_US
dc.contributor.authorEuropean paediatric Soft tissue sarcoma Study Group (EpSSG) and the European Innovative Therapies for Children with Cancer (ITCC) Consortiumen_US
dc.coverage.spatialEnglanden_US
dc.date.accessioned2018-02-15T16:07:55Z
dc.date.issued2017-09en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/28738258en_US
dc.identifierS0959-8049(17)31066-3en_US
dc.identifier.citationEur J Cancer, 2017, 83 pp. 177 - 184en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1143
dc.identifier.eissn1879-0852en_US
dc.identifier.doi10.1016/j.ejca.2017.06.015en_US
dc.description.abstractPURPOSE: We evaluated the role of bevacizumab as part of the multi-modality treatment of children and adolescents with metastatic rhabdomyosarcoma (RMS) or non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). PATIENTS AND METHODS: Eligible patients aged ≥6 months to <18 years were randomised to receive induction chemotherapy (four cycles of IVADo + five cycles of IVA, ±bevacizumab), surgery and/or radiotherapy, followed by maintenance chemotherapy (12 cycles of low-dose cyclophosphamide + vinorelbine, ±bevacizumab). The primary objective was event-free survival (EFS) evaluated by an independent radiological review committee. RESULTS: One hundred and fifty-four patients were randomised to receive chemotherapy alone (n = 80) or with bevacizumab (n = 74). At the data cut-off for the primary efficacy analysis, median EFS was 14.9 months (95% confidence interval [CI]: 10.8-35.9) with chemotherapy and 20.6 months (95% CI: 15.2-24.9) with bevacizumab plus chemotherapy (stratified hazard ratio [HR] = 0.93; 95% CI: 0.61-1.41; P = 0.72). The HR for EFS in patients with RMS (n = 103) was 1.24 (95% CI: 0.73-2.09) versus 0.64 (95% CI: 0.32-1.26) for those with NRSTS (n = 49). Objective response rate was 36.0% (95% CI: 25.2-47.9) with chemotherapy and 54.0% (95% CI: 40.9-66.6) with bevacizumab plus chemotherapy (difference of 18.0%; 95% CI: 0.6-35.3). There were no treatment-related deaths and no increased incidence of grade 3/4 toxicities with bevacizumab. CONCLUSION: The addition of bevacizumab to chemotherapy appeared tolerable in children and adolescents with metastatic RMS/NRSTS, but the primary end-point of EFS did not show statistically significant improvement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00643565.en_US
dc.format.extent177 - 184en_US
dc.languageengen_US
dc.language.isoengen_US
dc.subjectBevacizumaben_US
dc.subjectMetastatic soft tissue sarcomaen_US
dc.subjectNRSTSen_US
dc.subjectPaediatricsen_US
dc.subjectRMSen_US
dc.subjectAdolescenten_US
dc.subjectAngiogenesis Inhibitorsen_US
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen_US
dc.subjectBevacizumaben_US
dc.subjectChilden_US
dc.subjectChild, Preschoolen_US
dc.subjectDisease-Free Survivalen_US
dc.subjectFemaleen_US
dc.subjectHumansen_US
dc.subjectInduction Chemotherapyen_US
dc.subjectInfanten_US
dc.subjectMaintenance Chemotherapyen_US
dc.subjectMaleen_US
dc.subjectSarcomaen_US
dc.subjectSoft Tissue Neoplasmsen_US
dc.titleOpen-label, multicentre, randomised, phase II study of the EpSSG and the ITCC evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients with metastatic soft tissue sarcoma (the BERNIE study).en_US
dc.typeJournal Article
dcterms.dateAccepted2017-06-15en_US
rioxxterms.versionofrecord10.1016/j.ejca.2017.06.015en_US
rioxxterms.licenseref.startdate2017-09en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfEur J Canceren_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/Sarcoma Clinical Trials in Children and Young People
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Sarcoma Clinical Trials in Children and Young People/Sarcoma Clinical Trials in Children and Young People (hon.)
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Sarcoma Clinical Trials in children and young people
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Molecular Pathology/Sarcoma Clinical Trials in children and young people/Sarcoma Clinical Trials in Children and Young People (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume83en_US
pubs.embargo.termsNot knownen_US
icr.researchteamSarcoma Clinical Trials in children and young peopleen_US
dc.contributor.icrauthorChisholm, Juliaen_US
dc.contributor.icrauthorMarsden,en_US


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