Activity of afatinib administered in a window pre-operative study in squamous cell carcinoma of the head and neck (SCCHN) : EORTC-90111.

6049Background: Targeted agents (TA) are often investigated in unselected end-stage cancer patients (pts), making difficult to fully evaluate their activity and impairing translational research. One way to resolve this issue is to perform "window" studies where a TA is given between the diagnosis and surgery. Afatinib (A) is an oral ErbB family blocker that improves PFS of pts with recurrent SCCHN after platinum failure. Methods: This study was a randomized, multicenter, phase II window of opportunity trial. Treatment-naive SCCHN pts selected for primary curative surgery were randomized (5:1 ratio) to receive A during 14 days (day -15 until day -1) before surgery (day 0) or no treatment (B). Tumour biopsies, FDG/PET, and MRI were performed at diagnosis and at surgery. The primary end point was metabolic FDG-PET/CT response (centrally reviewed; H0 = 10%, H1 = 30%, Alpha = 10% 1-sided, Power = 90%); according to EORTC guidelines). Other endpoints included response by RECIST, DCE MRI, DWI MRI, and translatio...