Tumour response and safety of cetuximab in a window pre-operative study in patients with squamous cell carcinoma of the head and neck

• Published in: Annals of oncology Vol. 24; no. 9; pp. 2261 - 2266
• Main Authors: Schmitz, S., Hamoir, M., Reychler, H., Magremanne, M., Weynand, B., Lhommel, R., Hanin, F.-X., Duprez, T., Michoux, N., Rommel, D., Lonneux, M., Cappoen, N., Gillain, A., Machiels, J.-P.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.09.2013; Oxford University Press
• Subjects: Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - therapeutic use; Antineoplastic agents; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Carcinoma, Squamous Cell - diagnostic imaging; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - surgery; Cetuximab; ErbB Receptors - antagonists & inhibitors; Fluorodeoxyglucose F18; head and neck cancer; Head and Neck Neoplasms - diagnostic imaging; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - surgery; Humans; Medical sciences; Multiple tumors. Solid tumors. Tumors in childhood (general aspects); Otorhinolaryngology (head neck, general aspects and miscellaneous); Otorhinolaryngology. Stomatology; Pharmacology. Drug treatments; Positron-Emission Tomography; Squamous Cell Carcinoma of Head and Neck; targeted therapy; Treatment Outcome; Tumors; head and neck cancer; targeted therapy; cetuximab; Antineoplastic agent; Human; Targeted therapy; Toxicity; Monoclonal antibody; Malignant tumor; Epidermal growth factor receptor; Treatment; ENT disease; Head and neck cancer; Head and neck squamous cell carcinoma; Cetuximab; Tumor response; Cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdt180

To investigate the safety and activity of cetuximab in the pre-operative treatment of squamous cell carcinoma of the head and neck (SCCHN). Cetuximab was administered for 2 weeks before surgery to 33 treatment-naïve patients selected for primary surgical treatment. Tumour biopsies, 2-[fluorine-18]-fluoro-2-deoxy-d-glucose positron emission tomography (18FDG-PET) and imaging were carried out at baseline and before surgery. The primary aim of the study was safety and the secondary aims included metabolical, radiological and pathological tumour response. Five untreated patients were included as controls. Cetuximab given 24 h before surgery was safe. Ninety percent of patients had 18FDG-PET partial response (EORTC guideline) in the cetuximab group versus 0% in the control group. Delta maximal standardized uptake values (ΔSUVmax) were correlated with tumour cellularity on the surgical specimens (P < 0.0001). For patients with ΔSUVmax less than -25% or less than -50%, Ki67 was significantly decreased by cetuximab (P = 0.01 and 0.003). Cetuximab induced down-regulation of pEGFR (P = 0.0004) and pERK (P = 0.003). Short-course pre-operative administration of cetuximab is safe and shows a high rate of 18FDG-PET response. 18FDG-PET response was correlated with residual tumour cellularity suggesting that 18FDG-PET deserves further investigation as a potential early marker of cetuximab activity in SCCHN.