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.