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dc.contributor.authorForster, MD
dc.contributor.authorDillon, MT
dc.contributor.authorKocsis, J
dc.contributor.authorRemenár, É
dc.contributor.authorPajkos, G
dc.contributor.authorRolland, F
dc.contributor.authorGreenberg, J
dc.contributor.authorHarrington, KJ
dc.date.accessioned2020-04-03T11:07:03Z
dc.date.issued2019-12
dc.identifier.citationEuropean journal of cancer (Oxford, England : 1990), 2019, 123 pp. 36 - 47
dc.identifier.issn0959-8049
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3582
dc.identifier.eissn1879-0852
dc.identifier.doi10.1016/j.ejca.2019.08.017
dc.description.abstractBACKGROUND:The fully human monoclonal antibody patritumab blocks HER3 activation, a resistance mechanism to cetuximab, induced by heregulin (HRG). A phase Ib study in recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) demonstrated tolerability and tumour response of patritumab + cetuximab + platinum. METHODS:This was a randomised, double-blind, phase II study of patritumab + cetuximab with platinum-based therapy for first-line treatment of R/M SCCHN (Clinicaltrials.gov identifier: NCT02633800). Patients aged ≥18 years received patritumab or placebo, both combined with cetuximab + cisplatin or carboplatin. Co-primary end-points were progression-free survival (PFS) in the intent-to-treat (ITT) and the high-expression HRG (HRG high) populations. RESULTS:Eighty-seven patients (n = 43 in the patritumab group; n = 44 in placebo group) enrolled. A median (range) of 6.5 (1-24) patritumab cycles were completed. Median PFS was similar between the patritumab group and placebo group in the ITT population (5.6 versus 5.5 months; hazard ratio [HR] 0.99 [95% confidence interval [CI], 0.6-1.7]; P = 0.96) and HRG-high subgroup (n = 51; 5.6 versus 5.6 months; HR 0.93 [95% CI, 0.5-1.8]; P = 0.82). Median overall survival in the ITT population was also similar (10.0 versus 12.7 months; HR 1.3 [95% CI, 0.69-2.29]; P = 0.46). All patients experienced ≥1 treatment-emergent adverse event (TEAE). Grade ≥III TEAEs were more frequent in the patritumab than the placebo group (84.1% versus 60.5%). The most common grade ≥III patritumab-related TEAE in the patritumab group (20.5% overall) was rash (6.8%). CONCLUSION:Patritumab + cetuximab + platinum was tolerable but not superior to cetuximab + platinum.
dc.formatPrint-Electronic
dc.format.extent36 - 47
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://creativecommons.org/licenses/by/4.0
dc.subjectHumans
dc.subjectHead and Neck Neoplasms
dc.subjectNeoplasm Metastasis
dc.subjectNeoplasm Recurrence, Local
dc.subjectCisplatin
dc.subjectCarboplatin
dc.subjectReceptor, erbB-3
dc.subjectNeuregulin-1
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectDouble-Blind Method
dc.subjectDrug Resistance, Neoplasm
dc.subjectAdult
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectIntention to Treat Analysis
dc.subjectAntibodies, Monoclonal, Humanized
dc.subjectCetuximab
dc.subjectSquamous Cell Carcinoma of Head and Neck
dc.subjectProgression-Free Survival
dc.subjectBroadly Neutralizing Antibodies
dc.titlePatritumab or placebo, with cetuximab plus platinum therapy in recurrent or metastatic squamous cell carcinoma of the head and neck: A randomised phase II study.
dc.typeJournal Article
dcterms.dateAccepted2019-08-26
rioxxterms.versionofrecord10.1016/j.ejca.2019.08.017
rioxxterms.licenseref.urihttps://creativecommons.org/licenses/by/4.0
rioxxterms.licenseref.startdate2019-12
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfEuropean journal of cancer (Oxford, England : 1990)
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/Cancer Biology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy
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/Cancer Biology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy
pubs.publication-statusPublished
pubs.volume123
pubs.embargo.termsNot known
icr.researchteamTargeted Therapyen_US
dc.contributor.icrauthorHarrington, Kevinen
dc.contributor.icrauthorDillon, Magnusen


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