Predictor: Randomized phase II study of preoperative afatinib in untreated nonmetastatic head and neck squamous cell carcinoma patients (HNSCC) aiming at identifying predictive and pharmacodynamic biomarkers of efficacy.

TPS6105 Background: Identification of efficacy predictive biological biomarkers in HNSCC patients treated with anti-EGFR targeted therapy is still a challenge. In the recurrent/metastatic setting, sequential biopsies allowed correlating potential predictive and pharmacodynamic biomarkers with the outcome of patients treated with erlotinib (Agulnik M et al. J Clin Oncol. 2007;25:2184). Afatinib is an Erb-B family blocker that irreversibly blocks signaling from all relevant Erb-B family dimers and may overcome limitations of current EGFR-targeted treatment in HNSCC. We conduct a randomized phase II study with afatinib Methods: PREDICTOR is a UNICANCER sponsored multi-centre randomized phase II study of pre-operative afatinib aiming at identifying predictive and pharmacodynamic biomarkers of biological activity and efficacy in untreated non-metastatic HNSCC patients. Key eligibility criteria: confirmed non-metastatic HNSCC; T2-4N0-2 tumors (except T2N0 endolaryngeal tumors); planned date of surgery allowing ...