A phase I/II study of erlotinib in combination with chemoradiation in patients with surgically resected locally advanced squamous head and neck cancer (HNSCC).

TPS266 Background: Standard postoperative treatment for high-risk locally advanced HNSCC is concurrent chemoradiation (CRT). Despite innovative strategies, prognosis of these patients remains poor. Up to 90% of HNSCC overexpresses the EGF receptor. Erlotinib (e) is an oral tyrosine-kinase inhibitor of EGFR, with activity in HNSCC. The Spanish Group of Clinical Research in Radiation Oncology (GICOR) sponsors a multicenter non randomized phase I/II study evaluating the addition of E to CRT therapy of patients (pts) with surgically resected locally advanced HNSCC. Methods: The study comprises an early dose-escalating phase I, consisting on 3 cohorts of 3-6 pts each, with increasing doses of E (100-150 mg po qd) and cisplatin (C) (30-40 mg/m2, iv, d 1) for 7 weeks (w). Radiation therapy (RT) is delivered as a standard regimen of daily 1.8 Gy (5 fractions/w) to a maximum total dose of 63 Gy along 7 w. Pts should have diagnosis of HNSCC, with at least one of these criteria: T3 or T4 primary lesion (except T3N0 ...