dc.contributor.author | Dillon, MT | |
dc.contributor.author | Grove, L | |
dc.contributor.author | Newbold, KL | |
dc.contributor.author | Shaw, H | |
dc.contributor.author | Brown, NF | |
dc.contributor.author | Mendell, J | |
dc.contributor.author | Chen, S | |
dc.contributor.author | Beckman, RA | |
dc.contributor.author | Jennings, A | |
dc.contributor.author | Ricamara, M | |
dc.contributor.author | Greenberg, J | |
dc.contributor.author | Forster, M | |
dc.contributor.author | Harrington, KJ | |
dc.date.accessioned | 2019-01-04T10:41:50Z | |
dc.date.accessioned | 2019-01-04T10:49:43Z | |
dc.date.accessioned | 2019-01-04T10:52:37Z | |
dc.date.issued | 2019-01-15 | |
dc.identifier.citation | Clinical cancer research : an official journal of the American Association for Cancer Research, 2019, 25 (2), pp. 487 - 495 | |
dc.identifier.issn | 1078-0432 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/2994 | |
dc.identifier.eissn | 1557-3265 | |
dc.identifier.doi | 10.1158/1078-0432.ccr-18-1539 | |
dc.description.abstract | PURPOSE: 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. PATIENTS AND METHODS: 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. | |
dc.format | Print-Electronic | |
dc.format.extent | 487 - 495 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | AMER ASSOC CANCER RESEARCH | |
dc.relation.replaces | https://repository.icr.ac.uk/handle/internal/2992 | |
dc.relation.replaces | internal/2992 | |
dc.relation.replaces | https://repository.icr.ac.uk/handle/internal/2993 | |
dc.relation.replaces | internal/2993 | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Neoplasm Metastasis | |
dc.subject | Recurrence | |
dc.subject | Platinum | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Neoplasm Staging | |
dc.subject | Prognosis | |
dc.subject | Treatment Outcome | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Antibodies, Monoclonal, Humanized | |
dc.subject | Cetuximab | |
dc.subject | Squamous Cell Carcinoma of Head and Neck | |
dc.subject | Broadly Neutralizing Antibodies | |
dc.title | Patritumab with Cetuximab plus Platinum-Containing Therapy in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck: An Open-Label, Phase Ib Study. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2018-10-12 | |
rioxxterms.versionofrecord | 10.1158/1078-0432.ccr-18-1539 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2019-01 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Clinical cancer research : an official journal of the American Association for Cancer Research | |
pubs.issue | 2 | |
pubs.notes | No embargo | |
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-status | Published | |
pubs.volume | 25 | |
pubs.embargo.terms | No embargo | |
icr.researchteam | Targeted Therapy | |
dc.contributor.icrauthor | Dillon, Magnus | |
dc.contributor.icrauthor | Harrington, Kevin | |