However, the clinical experiences with EGFR TKIs in HNSCC were disappointing: A single arm study on Gefitinib monotherapy in recurrent or metastatic HNSCC observed a response rate of 10.6% [9], a multicenter phase 2 study of Erlotinib monotherapy obtained an objective response rate of 4.3% and a disease stabilization for 4 months in 38% of the patients but lacked a clear conclusion due to the lack of a control arm [10]. Here, EGFR is linked to head and neck squamous cell carcinoma.