@article{03c37b904c7d11df928f000ea68e967b,
title = "Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck",
abstract = "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 safely administered in doses up to 8 mg/kg, and preliminary data on tumour response are encouraging.",
author = "Lars Bastholt and Lena Specht and Kenneth Jensen and Eva Brun and Annika Loft and J{\o}rgen Petersen and Helle Kastberg and Eriksen, {Jesper G}",
note = "Keywords: Aged; Antibodies, Monoclonal; Carcinoma, Squamous Cell; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Receptor, Epidermal Growth Factor",
year = "2007",
doi = "10.1016/j.radonc.2007.06.007",
language = "English",
volume = "85",
pages = "24--8",
journal = "Radiotherapy & Oncology",
issn = "0167-8140",
publisher = "Elsevier Ireland Ltd",
number = "1",
}