Gene expression profiling in EORTC 90111 study, a window of opportunity trial with afatinib in HNSCC

In the EORTC 90111, open-label, randomised, multicentre, phase II trial, patients were treated with afatinib for 14 days (day 15 until day 1) before surgery (day 0). Tumour biopsies, 2-[fluorine-18]-fluoro-2-deoxy-d-glucose positron emission tomography (18-FDG PET) and magnetic resonance imaging (MRI) were performed at diagnosis and just before surgery. The main aim of the study was to identify predictive biomarkers among treatment-naive patients in this curative setting. Eligible patients had to have a new histological diagnosis of HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and be selected for primary curative surgery. Thirty-eight samples corresponding to paired pre- and post-treatment specimens belonging to 19 cases were profile for gene expression. The primary tumor needs to be ≥ 2 cm in their largest diameter measured bidimensionally by imaging done within two weeks prior to randomization. The primary outcome was the reduction in the tumor uptake volume as assessed by FDG-PET. The response to therapy was expressed as a continuous trait representing the change in SUVmax between the pre- and post-treatment as: ΔSUV = (SUVmax post – SUVmax pre)/SUVmax pre.