Phase II study of 250 mg gefitinib in advanced squamous cell carcinoma of the head and neck (SCCHN)

5586 Background: Inhibition of EGFR has demonstrated benefit in SCCHN. Treatment of patients with incurable SCCHN with 500 mg gefitinib PO QD produced an 11% response rate, 53% disease control rate and 29% overall survival at 1 year (JCO 21: 1980, 2003). However better tolerability and equal efficacy to this dose was reported in non-small cell lung cancer patients treated with 250 mg gefitinib . This phase II study of 250 mg gefitinib evaluated activity, toxicity and VEGF levels in patients with advanced SCCHN. Methods: Patients had incurable SCCHN, measurable disease, no prior EGFR-based therapy, ECOG PS ≤ 2, intact organ function, and ability to give informed consent. Patients received gefitinib 250 mg QD PO or via feeding tube. The primary endpoint was objective response rate (CR + PR). Correlative studies included plasma VEGF levels and quality of life measurements using FACT HN Symptom Index score. Results: 65 patients were enrolled from 6/02 to 11/03: 43 men, 22 women; median age 57.5 years; 19 loca...