Study objectives and endpoints
tumor, death
DISEASE PROGRESSION, SECONDARY, TUMOR
The main objective consisted in identifying predictive biomarkers of efficacy by exploring correlation between baseline potential biomarkers and radiological and metabolic responses to afatinib. Secondary objectives were to identify potential pharmacodynamic biomarkers, to evaluate the efficacy and safety of afatinib and to assess the metabolic and pathologic responses. We also did post-hoc analyses to evaluate the prognostic significance of recurrent genomic alterations and TMB in HNSCC.The primary endpoint was the biological assessment of afatinib activity by performing translational researches in pre-treatment biopsy and surgical specimen. Translational researches included DNAseq, RNAseq and high throughput protein analysis using RPPA methods.For secondary endpoints, efficacy was defined as the tumor size reduction between baseline and before surgery. The tumor size was the sum of two target lesions following measurement rules on CT scan/MRI of the head and neck according to RECIST1.1For post-hoc analyses, OS was defined as the time from randomization until death from any cause or last follow-up. PFS was defined as the time from randomization to disease progression or death from any cause or last follow-up.