尼妥珠单抗联合三维适形放疗及化疗治疗局部晚期鼻咽癌的初步临床研究

  目的   探讨尼妥珠单抗联合同期三维适形放疗(3D-CRT)及化疗治疗Ⅲ、ⅣA期鼻咽癌的疗效及不良反应。   方法  经组织病理确诊的Ⅲ、ⅣA期(2008分期)鼻咽癌初诊患者63例随机分为对照组(33例)和治疗组(30例), 均采用3D-CRT及同期和序贯紫杉醇顺铂方案化疗, 治疗组每周一放疗前行尼妥珠单抗100mg治疗, 共6~7次。   结果   放疗结束后2个月原发灶CR率、颈部淋巴结CR率治疗组分别为100.0%、96.7%, 明显高于对照组的81.8%及75.8%(P均 < 0.05), 放疗后1年局部控制率、无转移生存率在治疗组及对照组分别达到100.0%vs.89.3%、95.5%vs.82.1%(P > 0.05), 两组主要不良反应为放射性咽喉炎、放射性皮炎和恶心呕吐、白细胞减少、疲乏等, 耐受性较好。治疗组发生3度以上放射性咽喉炎(P < 0.05)、放射性皮炎(P > 0.05)较对照组偏高。   结论   尼妥珠单抗联合3D-CRT及紫杉醇及顺铂同期及序贯化疗治疗局部晚期鼻咽癌, 可提高近期完全缓解率及局部控制率, 耐受性较好, 远期生存率有待进一步观察研究。 

Primary Clinical Study on Nimotuzumab with 3D-CRT and Chemotherapy for Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma

  Objective   To determine the safety and tolerability ofnimotuzumab, a humanized anti-epidermal growth factor receptor monoclonal antibody, in combination with three-dimensional conformal radiotherapy (3D-CRT) and chemotherapy for locoregionally advanced nasopharyngeal carcinoma.   Methods   A total of 63 patients with stages III-IVA nasopharyngeal carcinoma were enrolled and divided into two groups: a research group with 30 patients and a control group with 33 patients. All patients were treated with 3D-CRT as well as concurrent and sequential chemotherapy with paclitaxel and cisplatin. Patients in the research group were intravenously administered 100 mg of nimotuzumab weekly for 6 weeks to 7 weeks before radiotherapy.   Results   Two months after radiotherapy, the complete response rates (CR) of nasopharyngeal cancer and cervix lymph nodes were 100% and 96.7%, respectively, in the research group, and 81.8% and 75.8%, respectively, in the control group. A significant difference was indicated (P < 0.05). The 1-year locoregional control and distant metastasis-free survival rates were 71.4% and 95.5%, in the control group and the research group, respectively. No significant difference was indicated (P=0.068 > 0.05). Major side effects included oral mucositis, actinodermatitis, neutropenia, nausea, vomiting, and fatigue; however, these effects were tolerable. A significant difference was found in the frequency of grade 3 to grade 4 acute oral mucositis between the groups (P < 0.05).   Conclusion   Nimotuzumab combined with 3D-CRT and paclitaxel and cisplatin chemotherapy can improve the CR on locoregionally advanced nasopharyngeal carcinoma, with mild to moderate side effects. Further study may be conducted to observe the distant metastasis-free survival rates.