Platinum-based Chemotherapy Plus Cetuximab for the First-line Treatment of Japanese Patients with Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck: Results of a Phase II Trial

Objective: To assess the efficacy and safety of cetuximab in combination with cisplatin and 5-fluorouracil for first-line treatment of Japanese patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Methods: In this open-label, single-arm, multicenter, Phase II study conducted in Japan, patients with confirmed recurrent and/or metastatic squamous cell carcinoma of the head and neck received weekly cetuximab (week 1, 400 mg/m2; subsequent weeks, 250 mg/m2) plus a maximum of six three-weekly cycles of cisplatin (100 mg/m2, day 1) and 5-fluorouracil (1000 mg/m2/day, 24-h infusion, days 1–4). The primary endpoint was the best overall re-sponse assessed by an independent review committee according to the modified World Health Organization criteria. Results: In total, 33 patients received treatment. The most frequent primary tumor site was the hypopharynx (42%), and most patients had metastatic disease (85%). The best overall re