Clinical study of cetuximab combined with concurrent chemoradiotherapy for esophageal squamous cell carcinoma

Objective: To determine the feasibility and toxicity of the addition of cetuximab to paclitaxel, cisplatin, and concurrent intensity modulated radiation therapy (IMRT) for patients with esophageal squamous cell carcinoma (ESCC). Methods: Nineteen patients with stage I to III ESCC, without distant organ metaslases, were eligible. All patients received cetuximab, an initial dose of 400 mg/m² in the first week followed by weekly injection of 250 mg/m², paclitaxel 45 mg/m² and cisplatin 20 mg/m² weekly for 7 weeks with IMRT of 59.4 Gy/33 fractions. Results: Two patients discontinued because of severe adverse events. Seventeen patients completed the planned treatment protocol. Of whom, 12 patients achieved complete remission. The objective response rate was 100%. A median follow-up time was 29.3 months. The 1-year overall survival and recurrence-free survival rate was 100% and 82%, respectively. Main toxicities including myelosuppression, esophagitis and skin rash happened in 19 patients. Grade ≥ 2 neutropenia, esophagitis and skin toxicity noted rates was 89%, 84% and 58%, respectively. Local recurrence was found in two patients. Neck lymph node and lung metastasis found in one patient. Conclusions: Cetuximab, when combined with paclitaxel, cisplatin and IMRT, is efficient and safe for esophageal squamous cell carcinoma, Further clinical study is needed. (authors)