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

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Standard

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. / Bastholt, Lars; Specht, Lena; Jensen, Kenneth; Brun, Eva; Loft, Annika; Petersen, Jørgen; Kastberg, Helle; Eriksen, Jesper G.

I: Radiotherapy & Oncology, Bind 85, Nr. 1, 2007, s. 24-8.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt

Harvard

Bastholt, L, Specht, L, Jensen, K, Brun, E, Loft, A, Petersen, J, Kastberg, H & Eriksen, JG 2007, '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', Radiotherapy & Oncology, bind 85, nr. 1, s. 24-8. https://doi.org/10.1016/j.radonc.2007.06.007

APA

Bastholt, L., Specht, L., Jensen, K., Brun, E., Loft, A., Petersen, J., Kastberg, H., & Eriksen, J. G. (2007). 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. Radiotherapy & Oncology, 85(1), 24-8. https://doi.org/10.1016/j.radonc.2007.06.007

Vancouver

Bastholt L, Specht L, Jensen K, Brun E, Loft A, Petersen J o.a. 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. Radiotherapy & Oncology. 2007;85(1):24-8. https://doi.org/10.1016/j.radonc.2007.06.007

Author

Bastholt, Lars ; Specht, Lena ; Jensen, Kenneth ; Brun, Eva ; Loft, Annika ; Petersen, Jørgen ; Kastberg, Helle ; Eriksen, Jesper G. / 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. I: Radiotherapy & Oncology. 2007 ; Bind 85, Nr. 1. s. 24-8.

Bibtex

@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",

}

RIS

TY - JOUR

T1 - 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

AU - Bastholt, Lars

AU - Specht, Lena

AU - Jensen, Kenneth

AU - Brun, Eva

AU - Loft, Annika

AU - Petersen, Jørgen

AU - Kastberg, Helle

AU - Eriksen, Jesper G

N1 - Keywords: Aged; Antibodies, Monoclonal; Carcinoma, Squamous Cell; Female; Head and Neck Neoplasms; Humans; Male; Middle Aged; Receptor, Epidermal Growth Factor

PY - 2007

Y1 - 2007

N2 - 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.

AB - 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.

U2 - 10.1016/j.radonc.2007.06.007

DO - 10.1016/j.radonc.2007.06.007

M3 - Journal article

C2 - 17602769

VL - 85

SP - 24

EP - 28

JO - Radiotherapy & Oncology

JF - Radiotherapy & Oncology

SN - 0167-8140

IS - 1

ER -

ID: 19370673