Phase II Study of Cetuximab Plus Concomitant Boost Radiotherapy in Japanese Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Background: We investigated the tolerability of cetuximab plus radiotherapy in Japanese patients with untreated locally advanced squamous cell carcinoma of the head and neck. Methods: Patients with epidermal growth factor receptor-expressing locally advanced squa-mous cell carcinoma of the head and neck received cetuximab (400 mg/m2 initial dose then 250 mg/m2 weekly) for 7 weeks plus concomitant boost radiotherapy (weeks 2–7: once daily [1.8 Gy] for 3.6 weeks, then twice daily [1.8 Gy morning and 1.5 Gy afternoon] for 2.4 weeks). The primary endpoint was treatment completion rate (the rate of treated patients completing 70 % of the planned cetuximab dose and the full dose of radiotherapy within 2 weeks over the planned schedule). Results: Twenty-two patients were evaluable. The treatment completion rate was 100% (95 % confidence interval 85–100). The response rate 8 weeks post-radiotherapy was 82% (95 % confidence interval 60–95). The most common grade 3/4 treatment-emergent adverse events were mucosal inflammation (73%); dermatitis (27%); and infection, radiation ski