Nimotuzumab in combination with preoperative concurrent chemoradiotherapy for locally advanced esophageal squamous cell carcinoma: A prospective trial.

Abstract

101 Background: Preoperative chemoradiotherapy is an accepted standard treatment for patients with locally advanced esophageal cancer. Nimotuzumab is a monoclonal antihuman EGFR IgG1 antibody that has demonstrated synergistic activity with both radiotherapy and platinum-based chemotherapy in some solid tumors. The aim of this study is to investigate the safety and efficacy of nimotuzumab in combination with preoperative concurrent chemoradiotherapy for locally advanced esophageal squamous cell carcinoma (ESCC). Methods: Previously untreated patients with stage II-III ESCC received nimotuzumab (200mg per week in weeks1-5), paclitaxel(45 mg/m2 per week in weeks 2-5), cisplatin(20 mg/m2 per week in weeks 2-5) and radiotherapy at a total dose of 40 Gy (2.0Gy/d,5 days per week in weeks 2-5). Esophagectomy was performed 4 weeks after the completion of preoperative strategies. Results: Eighteen eligible patients were enrolled. All patients completed the preoperative regimen, and seventeen patients underwent surgery. The clinical response rate was 94.4% (17/18). The most frequent Grade 1/2 toxicities were esophagitis(12/17), leukocytopenia(14/17), nausea/vomiting(8/17) and fatigue(4/17). Grade 3 leukocytopenia was observed in 11.8 % of patients (3/17). The rate of radical resection was 100%, and the pathological complete response rate was 41.2%(7/17). Downstaging occurred in 15/17 (88.2 %) patients by T stage and 8/17 (47.1%) by N stage. The incidences of postoperative anastomotic leak, pulmonary infection, hoarseness and arrhythmia were 11.8%, 11.8%, 5.9%, and 5.9%, respectively. No perioperative deaths occurred in the study. Conclusions: The regimen of nimotuzumab in combination with preoperative concurrent chemoradiotherapy is safe for locally advanced ESCC. The preoperative strategy is able to achieve substantially high clinical response rate and pathological complete response rate.