尼妥珠单抗联合术前同期放化疗治疗局部进展期食管鳞癌初步临床研究

目的 初步观察尼妥珠单抗联合术前同期放化疗治疗局部进展期食管鳞癌的治疗结果。方法 共23例Ⅱ-Ⅲ期食管鳞癌患者入组,尼妥珠单抗 200 mg,第1-5周应用,1 次/周。DDP 20 mg/m²,PTX 45 mg/m²,第2-5周应用,1 次/周。放疗第2-5周进行,2 Gy/次,5 次/周,共40 Gy。新辅助治疗结束后4周行手术切除。结果 全组23例患者均完成术前放化疗及尼妥珠单抗治疗,22例接受手术切除。术前治疗的临床有效率为96%,毒副反应主要为胃肠道反应、骨髓抑制及黏膜炎,大多为1-2级。手术R0切除率为100%,病理完全缓解率为41%。术后肺部感染、吻合口瘘、声嘶、心律失常的发生率分别为14%、9%、4%、4%,无围手术期死亡病例发生。全组1、3、5年生存率分别为86%、52%、52%,中位生存时间为28.9个月。术后淋巴结阴性(15例)和淋巴结阳性(7例)组1、3、5年生存率分别为100%、62%、62%和57%、29%、29%(P=0.033),中位生存时间分别为42.6个月和14.2个月。结论 尼妥珠单抗联合术前同期放化疗治疗局部进展期食管鳞癌安全有效,术后淋巴结阴性患者的长期生存率显著提高。

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

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.