Preliminary clinical study of Nituzumab combined with neoadjuvant concurrent chemoradiotherapy for locally advanced esophageal squamous cell carcinoma

Abstract

Objective To determine the treatment outcome of nimotuzumab in combination with neoadjuvant concurrent chemoradiotherapy followed by surgery for locally advanced esophageal squamous cell carcinoma (ESCC). Methods A total of 23 ESCC patients were enrolled. The preoperative strategies consisted of nimotuzumab (200 mg per week in week 1-5), concurrent chemotherapy by paclitaxel (45 mg/m2 per week in week 2-5) and cisplatin (20 mg/m2 per week in week 2-5) and radiotherapy by a total dose of 40 Gy (2. 0 Gy/d, 5 days per week in week 2-5). Esophagectomy was performed 4 weeks after the completion of preoperative therapies. Results All of the 23 patients enrolled completed the planned combined therapy method, and 22 patients underwent final surgery. The clinical response rate of nimotuzumab in combination with preoperative chemoradiotherapy was 96%. The most frequent Grade 1/2 toxicities observed were gastrointestinal reaction, bone marrow suppression, and esophagitis. The rate of radical resection was 100%, and the pathological complete response rate was 41%.The incidence rate of postoperative pulmonary infection, anastomotic leak, hoarseness, and arrhythmia were 14%, 9%, 4%, and 4%, respectively. No perioperative deaths occurred in our study. The 1-, 3-, and 5-year overall survival (OS) rate for all the patients were 86%, 52% and 52%, respectively. The median survival time (MST) was 28.9 months. Postoperative pathologic results showed 15 patients with lymph node negative and 7 patients with lymph node positive. the 1-, 3-, and 5-year OS for pN0 group were 100%, 62% and 62%, versus 57%, 29% and 29% for pN+ group (P=0.033). The MST for pN0 group was 42.6 months versus 14.2 months for pN+ group. Conclusions The regimen of nimotuzumab in combination with preoperative concurrent chemoradiotherapy followed by surgery is safe and effective for locally advanced ESCC. Patients with lymph node negative after surgery have significantly improved long-term survival. Key words: Esophageal neoplasms/targeted therapy; Esophageal neoplasms/radiochemotherapy; Treatment outcome