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dc.contributor.authorDillon, MTen_US
dc.contributor.authorGrove, Len_US
dc.contributor.authorNewbold, KLen_US
dc.contributor.authorShaw, Hen_US
dc.contributor.authorBrown, NFen_US
dc.contributor.authorMendell, Jen_US
dc.contributor.authorChen, Sen_US
dc.contributor.authorBeckman, RAen_US
dc.contributor.authorJennings, Aen_US
dc.contributor.authorRicamara, Men_US
dc.contributor.authorGreenberg, Jen_US
dc.contributor.authorForster, Men_US
dc.contributor.authorHarrington, KJen_US
dc.coverage.spatialUnited Statesen_US
dc.date.accessioned2019-01-04T10:41:50Z
dc.date.accessioned2019-01-04T10:49:43Z
dc.date.accessioned2019-01-04T10:52:37Z
dc.date.issued2018-10-16en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/30327312en_US
dc.identifier1078-0432.CCR-18-1539en_US
dc.identifier.citationClin Cancer Res, 2018en_US
dc.identifier.issn1078-0432en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2994
dc.identifier.doi10.1158/1078-0432.CCR-18-1539en_US
dc.description.abstractPurpose: Patritumab plus cetuximab with platinum as first-line therapy for patients with recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) was evaluated for safety and to determine the recommended phase II combination dose.Experimental Design: Patients aged ≥18 years with confirmed R/M SCCHN received intravenous patritumab (18 mg/kg loading dose; 9 mg/kg maintenance dose every 3 weeks) + cetuximab (400 mg/m2 loading dose; 250 mg/m2 maintenance dose weekly) + cisplatin (100 mg/m2 every 3 weeks) or carboplatin (AUC of 5) for six cycles or until toxicity, disease progression, or withdrawal. Primary endpoints were dose-limiting toxicities [DLT; grade ≥3 (21-day observation period)] and treatment-emergent adverse events (TEAE). Pharmacokinetics, human antihuman antibodies (HAHA), tumor response, progression-free survival (PFS), and overall survival (OS) were assessed.Results: Fifteen patients completed a median (range) of 8.7 (2.0-20.7) patritumab cycles. No DLTs were reported. Serious adverse events were reported in 9 patients (patritumab-related n = 4). TEAEs (N = 15 patients) led to patritumab interruption in 7 patients. Patritumab-related dose reductions were reported in 1 patient. Patritumab (18 mg/kg) pharmacokinetics (N = 15) showed mean (SD) AUC0-21d of 2,619 (560) μg/day/mL and maximum concentration of 499.9 (90.4) μg/mL. All patients were HAHA-negative at study end (single, transient low titer in 1 patient). Tumor response rate (complete plus partial response; N = 15) was 47%. Median (95% confidence interval) PFS and OS (N = 15) were 7.9 (3.7-9.7) and 13.5 (6.6-17.5) months, respectively.Conclusions: Patritumab (18 mg/kg loading dose, 9 mg/kg maintenance dose) plus cetuximab/platinum was tolerable, active in SCCHN, and selected as the phase II dose regimen.en_US
dc.languageengen_US
dc.language.isoengen_US
dc.relation.replaceshttps://repository.icr.ac.uk/handle/internal/2992
dc.relation.replacesinternal/2992
dc.relation.replaceshttps://repository.icr.ac.uk/handle/internal/2993
dc.relation.replacesinternal/2993
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.titlePatritumab with Cetuximab plus Platinum-Containing Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: An Open-Label, Phase Ib Study.en_US
dc.typeJournal Article
dcterms.dateAccepted2018-10-12en_US
rioxxterms.versionofrecord10.1158/1078-0432.CCR-18-1539en_US
rioxxterms.licenseref.startdate2018-10-16en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfClin Cancer Resen_US
pubs.notesNo embargoen_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/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 onlineen_US
pubs.embargo.termsNo embargoen_US
icr.researchteamTargeted Therapyen_US
dc.contributor.icrauthorDillon, Magnusen_US
dc.contributor.icrauthorHarrington, Kevinen_US


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