Journal
RADIOTHERAPY AND ONCOLOGY
Volume 85, Issue 1, Pages 24-28Publisher
ELSEVIER IRELAND LTD
DOI: 10.1016/j.radonc.2007.06.007
Keywords
human monoclonal antibody; epidermal growth factor receptor; pharmacokinetics; pharmacodynamics; phase I/II
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Purpose: To assess safety, tolerability, pharmacokinetics and clinical activity of HuMax-EGFr in patients with SCCHN. Patients and methods: Twenty-eight patients with SCCHN were enrolled. The study comprised a single-dose escalation part for assessment of safety issues followed by a repeat dose extension including 4 weekly infusions at the same doses. Efficacy and metabolic response were evaluated according to RECIST by CT and FDG-PET. Results: Most frequently reported adverse event was rash. All but one event were CTC grade 1 or 2 and a dose-dependent relationship was indicated. Duration of skin reactions varied from few days to 2 months. No DLTs were observed and MTD was not reached. In the two highest dose groups, 7 of 11 patients obtained a PR or SD and 9 patients obtained metabolic PR or SD. Conclusions: HuMax-EGFr can be safety administered in doses up to 8 mg/kg, and preliminary data on tumour response are encouraging. (c) 2007 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 85 (2007) 24-28.
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