Clinical and molecular phase II study of gefitinib in patients (pts) with recurrent squamous cell cancer of the head and neck (H&N Ca)

5531 Background: : Gefitinib an inhibitor of the epidermal growth factor receptor tyrosine kinase is commercially available for the treatment of refractory non-small cell lung cancer, and has shown clinical activity in squamous cell cancer of the head and neck. We report a phase II study undertaken to confirm clinical efficacy in head and neck cancer, and investigate the tumor molecular events associated with therapy. Methods: Group 1 pts could not have received systemic therapy for recurrent disease, and had to have relapsed at least 6 months after chemotherapy used during primary management. Group 2 pts could have received one treatment regimen for recurrent disease or have recurred within 6 months of primary management that included chemotherapy. Other eligibility criteria were ECOG PS ≤ 2, and adequate hematologic and serum chemistry values. Clinical Benefit was defined as a CR, PR or stable disease for ≥ 4 months by RECIST criteria. Gefitinib was administered at 500 mg orally daily with dose reductio...