尼妥珠单抗同期调强放疗及化疗治疗食管癌的临床研究

目的]探讨尼妥珠单抗同期调强放疗及化疗治疗食管癌的疗效及不良反应。方法]经病理确诊的食管癌初诊患者32例分为两组，对照组（n=16）采用调强放疗及化疗；观察组（n=16）除调强放疗及化疗外，每周放疗前进行尼妥珠单抗100mg治疗，共6～7次。结果]放疗结束后2个月复查完全缓解（CR）率，观察组为87．5％，对照组为68．8％，两组有效（RR）率均为100．0％；随访2年对照组和观察组的局部区域控制率为87．5％和100％（P〉0．05），而无远处转移生存率分别为62．5％和81．3％（P〉0．05）。两组主要不良反应为放射性食管黏膜炎、放射性皮炎和恶心呕吐、粒细胞减少、疲乏等，无皮疹及过敏反应发生，患者均能耐受。观察组发生2级以上放射性食管黏膜炎、粒细胞减少较对照组偏高，但差异无统计学意义（P〉0．05）。结论]尼妥珠单抗可提高食管癌对放疗的敏感性，提高有效率及降低复发转移率．安全有效。

Clinical Study on Nimotuzumab Combined with Intensity-modulated Radiotherapy and Chemotherapy for Esophageal Cancer

Purpose] To study the efficacy and side effects of nimotuzumab combined with concurrent intensity-modulated radiotherapy and chemotherapy in the treatment for esophageal cancer. Methods] Thirty-two esophageal cancer patients pathologically proved were divided into two group,control group （n=16） who received 3D conformal therapy and period chemotherapy, and observation group （n=16） received 100mg nimotuzumab administration before intensity modulated radiation therapy and period chemotherapy. All patients received 6 to 7 cycles. Results] Two months after radiotherapy,the complete remission rate in observation group was 87.5% while in control group it was 68.8%. The response rates were both 100.0%. The local regional control rates after 2 years＇ follow-up were 87.5% in control group and 100% in observation group （P〉0.05）,while the non-metastasis survival rates were 62.5% and 81.3% respectively （P〉0.05）. The toxicity in the 2 groups included radiation esophageal mucosal inflammation,radiation dermatities and nausea and vomiting,granulocytopenia,fatigue, but neither erythra nor allergy was found. Despite the rates of grade-2 radiation esophageal mucosal inflammation and granulocytopenia in observation group was higher than that in control group but without significant difference （P〉0.05）. Conclusion] Nimotuzumab could enhance the esophageal cancer pa- tients＇sensitivity on radiotherapy,increase response rate, and decrease recurrent rate.It is a safe and effective agent for esophageal cancer.