摘要目的:评价尼妥珠单抗联合根治性放疗治疗局部晚期不可手术的口腔颌面部鳞状细胞癌的有效性和安全性。方法:回顾性选取上海交通大学医学院附属第九人民医院于2015年3月至2019年12月收治的33例局部晚期不可手术的口腔颌面部鳞状细胞癌患者作为研究对象，治疗方案均为靶向治疗（尼妥珠单抗）联合根治性放疗，加或不加化疗，分析疗效和安全性。主要观察终点为最佳疗效和总生存期（OS），次要观察终点为最佳疗效持续时间（DOR）和无进展生存期（PFS）。采用Kaplan-Meier法绘制生存曲线，分析患者生存率。统计患者治疗相关不良反应。结果:33例患者中完全缓解（CR）20例，部分缓解（PR）5例，病情稳定（SD）5例，疾病进展（PD）2例，无法评估1例，客观有效率为75.8%（25/33），疾病控制率为90.9%（30/33）。全组患者平均OS为54.5个月，5年OS率为57.0%；总体平均DOR为57.2个月，5年DOR率64.4%；总体平均PFS为54.4个月，5年PFS率为59.8%。疗效评价为CR、PR和SD的患者5年OS率分别为83.6%、20.0%和0（ χ2=20.07， P<0.001），5年DOR率分别为85.0%、20.0%和0（ χ2=16.89， P<0.001），5年PFS率分别为84.0%、20.0%和0（ χ2=15.91， P<0.001）；CR患者的OS、DOR、PFS均明显优于PR和SD患者（均 P<0.05）。口咽癌和口腔癌患者5年OS率分别为62.5%和40.6%（ χ2=1.67， P=0.197），5年DOR率分别为73.3%和44.0%（ χ2=1.34， P=0.247），5年PFS率分别为68.8%和40.9%（ χ2=1.13， P=0.289），差异均无统计学意义，但口咽癌患者仍表现出一定的优势。常见不良反应包括口腔黏膜炎和血液学毒性，多为1~2级；2例（6.1%）患者出现皮疹，2例（6.1%）患者出现恶心、呕吐，考虑与尼妥珠单抗相关；所有不良反应对症处理后均缓解。 结论:对于不可手术的局部晚期口腔颌面部鳞状细胞癌患者，选择尼妥珠单抗联合根治性放疗有较为满意的有效率和生存率，安全性好，有较高的临床应用价值。

abstractsObjective:To evaluate the efficacy and safety of nimotuzumab combined with definitive radiotherapy in the treatment of inoperable locally advanced oral and maxillofacial squamous cell carcinoma.Methods:A total of 33 patients with inoperable locally advanced oral and maxillofacial squamous cell carcinoma admitted to the Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine from March 2015 to December 2019 were retrospectively selected as the research objects. The treatment regimen was all targeted therapy (nimotuzumab) combined with definitive radiotherapy, with or without chemotherapy, and the efficacy and safety of the treatment were analyzed. The primary endpoints were optimal response and overall survival (OS) , and the secondary endpoints were optimal duration of response (DOR) and progression-free survival (PFS) . The survival curve was drawn using the Kaplan-Meier method, the survival rate of the patients was analyzed, and the related adverse reactions were counted.Results:Of the 33 patients, there were 20 cases of complete remission (CR) , 5 cases of partial remission (PR) , 5 cases of stable disease (SD) , 2 cases of progressive disease (PD) , and 1 case could not be evaluated. The objective response rate was 75.8% (25/33) , and the disease control rate was 90.9% (30/33) . The mean OS of all cases was 54.5 months, and the 5-year OS rate was 57.0%. The mean DOR of the overall cases was 57.2 months, and the 5-year DOR rate was 64.4%. The mean PFS of the overall cases was 54.4 months, and the 5-year PFS rate was 59.8%. The 5-year OS rates of CR, PR and SD patients were 83.6%, 20.0% and 0 ( χ2=20.07, P<0.001) , the 5-year DOR rates were 85.0%, 20.0% and 0 ( χ2=16.89, P<0.001) , and the 5-year PFS rates were 84.0%, 20.0% and 0 ( χ2=15.91, P<0.001) . The OS, DOR and PFS of patients with CR were significantly better than those of patients with PR and SD (all P<0.05) . The 5-year OS rates of patients with oropharyngeal cancer and oral cancer were 62.5% and 40.6% ( χ2=1.67, P=0.197) , the 5-year DOR rates were 73.3% and 44.0% ( χ2=1.34, P=0.247) , and the 5-year PFS rates were 68.8% and 40.9% ( χ2=1.13, P=0.289) , with no statistically significant differences, but oropharyngeal cancer patients still showed a certain advantage. Common adverse reactions included oral mucositis and hematological toxicity, most of which were grade 1-2. Two (6.1%) patients had rash, and two (6.1%) patients had nausea and vomiting, which were considered to be related to nimotuzumab. All adverse reactions were relieved after symptomatic treatments. Conclusion:For patients with locally advanced oral and maxillofacial squamous cell carcinoma who are not suitable for surgery, the choice of nimotuzumab combined with definitive radiotherapy has a relatively satisfactory efficacy and survival rate, with good safety and high clinical value.