目的：评价长疗程尼妥珠单抗（nimotuzumab）联合调强放疗和化疗治疗局部晚期鼻咽癌有效性和安全性。方法：分析从2008年11月至2014年3月在浙江省肿瘤医院39例确诊为Ⅲ-Ⅳ期鼻咽癌患者，其中男性29例，女性10例；Ⅲ期20例，Ⅳa期14例，Ⅳb期5例。患者接受长疗程尼妥珠单抗联合调强放、化疗，尼妥珠单抗200 mg/次，1次/周，所有患者治疗9~18周。观察长疗程尼妥珠单抗联合调强放、化疗的疗效及毒副作用，参考RTOG标准分析患者急、慢性毒副作用；采用Kaplan-Meier方法、Log-rank法检验分析生存情况。结果： 所有患者接受9周期以上尼妥珠单抗联合调强放、化疗的治疗后，中位随访时间46月（22~86个月），3年无局部复发生存率（LRFS）、无区域复发生存率（RRFS）、无远处转移生存率（DMFS）、PFS和OS分别为92.1%、 89.7%、 82.5%、 77.6%和86.8%。单因素分析显示临床分期和新辅助化疗周期对生存率重要影响（3年DMFS Ⅲ、Ⅳ期分别为 100.0%和63.2%(P<0.01); 3年LRFS 1~2周期、3~4周期分别为75.0%和96.8%(P<005）。结论：长疗程尼妥珠单抗联合调强放疗、化疗提高局部晚期鼻咽癌的疗效，并不增加毒、副作用，其远期疗效有待于长期随访结果。

Objective:To evaluate the efficacy and safety of nimotuzumab combined with intensity-modulated radiotherapy and chemotherapy (IMRT) for long-term in treatment of the patients with local advanced nasopharyngeal carcinoma. Methods: Thirty nine patients who diagnosed as Ⅲ-Ⅳ stages nanopharyngeal carcinoma in the Zhejiang Cancer Hospital during November, 2008 to March, 2014 were analyzed, among them 29 cases are male and 10 cases female, 20 cases are at Ⅲ stage, 14 cases at Ⅳ a stage and 5 cases at Ⅳ b stage. All the patients received a long-term treatment of nimotuzumab (200 mg at a time, one time per week) combined with IMRT for 9-18 weeks. Curative efficacy and toxic side effects of the long-term treatment of nimotuzumab combined with IMRT were observed, as well as the acute and chronic toxic side effects of the patients were analyzed according to the criteria of Radiation Therapy Oncology Group (RTOG). Accumulated survival rates of the patients were calculated and analyzed by Kaplan-Meier method and Log-rank test. Results: With a median follw-up period of 46 months (22-86 months), after the long-term treatment of nimotuzumab combined with IMRT for more then nine months local recurrence free survival rate (LRFS), regional recurrence free survival rate (RRFS), distant metastasis free survival rate (DMFS), progression free survival rate (PFS) and overall survival rate (OS) for three years of all the patients were 92.1%, 89.7%, 82.5%, 77.6% and 86.8% respectively. Univariate analysis showed that clinical stages and cycle of new adjuvant chemotherapy have key effect on the survival rates, DMFS for three years of the patients at Ⅲ stage and Ⅳ stage were 100.0% and 63.2% respectively (P<0.01), LRFS for three years of the patients received the treatment 1-2 cycles and 3-4 cycles 75.0% and 96.8% respectively (P<0.05). Conclusion:The long-term treatment of nimotuzumab combined with intensity-modulated radiotherapy and chemotherapy could improve curative efficacy of the patients with local advanced nasopharyngeal carcinoma, but not increase toxic side effect. However long-term curative efficacy of the treatment might wait on results of follow up for a long period.

国家自然科学基金青年资助项目（No.81502647）