食管鳞癌西妥昔单抗联合同期放化疗的初步临床研究

目的 观察西妥昔单抗联合同期放化疗对食管鳞癌的安全性及近期疗效 方法 19例 Ⅰ~Ⅲ 期无远处转移的食管鳞癌患者入组,西妥昔单抗静脉滴注1 次/周, 第1周为400 mg/m²,第2~8周为250 mg/m², 每周联合紫杉醇45 mg/m²和顺铂20 mg/m²。第2~8周调强放疗59.4 Gy分33次。结果 2例 患者因严重不良反应出组, 17例的有效率为100%,其中完全缓解率为71%(12例)。中位随访时间29.3个月, 1年 总生存率、无复发生存率分别为100%,82%。19例 患者主要不良反应为骨髓抑制、黏膜反应、皮疹等,其中≥2级粒细胞减少、放射性食管炎、皮疹发生率分别为89%、84%、58%。2例局部复发, 1例后颈部淋巴结及肺转移。结论 西妥昔单抗联合同期放化疗对食管鳞癌安全有效,值得扩大样本量进行进一步临床研究。

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 metastases, 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 completeremission. 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.