Overexpression of epidermal growth factor receptor can be found in more than 80% of patients with locoregionally advanced nasopharyngeal carcinoma and is associated with shorter survival. In this work, we evaluated the feasibility of adding nimotuzumab to chemoradiation in locoregionally advanced nasopharyngeal carcinoma. Twenty-three patients with clinically staged T3-4 or any node-positive disease were enrolled. They were scheduled to receive one cycle of induction chemotherapy followed by intensity-modulated radiotherapy, weekly administration of nimotuzumab and concurrent chemotherapy. Results showed that all patients received a full course of radiotherapy, 19(82.6%)patients completed the scheduled neoadjuvant and concurrent chemotherapy, and 22(95.7%) patients received =6 weeks of nimotuzumab. During the period of concurrent chemoradiation and nimotuzumab, grade 3-4 toxicities occurred in 14(60.9%) patients: 8 (34.8%) had grade 3-4 oral mucositis, 6(26.1%) had grade 3 neutropenia, and 1(4.3%) had grade 3 dermatitis. No acne-like rash was observed. With a median follow-up of 24.1 months, the 2-year progression-free survival and overall survival were 83.5% and 95.0%, respectively. In conclusion, concurrent administration of chemoradiation and nimotuzumab was well-tolerated with good compliance. Preliminary clinical outcome data appear encouraging with favorable normal tissue toxicity results comparing with historical data of concurrent chemoradiation plus cetuximab.

中文翻译：

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局部区域晚期鼻咽癌的诱导化疗，同步放化疗和尼莫珠单抗：II期临床试验的初步结果

表皮生长因子受体的过表达可在局部区域晚期鼻咽癌的80％以上患者中发现，并与生存期较短有关。在这项工作中，我们评估了在局部晚期鼻咽癌的化学放疗中添加尼莫妥单抗的可行性。纳入了23例临床分期为T3-4或任何淋巴结阳性疾病的患者。他们计划接受一个周期的诱导化疗，然后进行强度调节放疗，尼莫妥单抗每周给药和同步化疗。结果显示，所有患者均接受了全疗程放疗，其中19（82.6％）名患者完成了预定的新辅助化疗和同步化疗，22名（95.7％）患者接受了= 6周的尼莫妥珠单抗治疗。在同时放化疗和尼莫妥珠单抗治疗期间，14例（60.9％）患者发生3-4级毒性反应：8例（3-4.8％）发生口腔粘膜炎，6例（26.1％）发生3级中性粒细胞减少，1例（4.3） ％）患有3级皮炎。没有观察到痤疮样皮疹。中位随访期为24.1个月，其2年无进展生存期和总生存期分别为83.5％和95.0％。总之，同时放化疗和尼莫妥单抗的耐受性良好，依从性良好。与同时放化疗联合西妥昔单抗的历史数据相比，初步的临床结果数据令人鼓舞，并且具有良好的正常组织毒性结果。没有观察到痤疮样皮疹。中位随访期为24.1个月，其2年无进展生存期和总生存期分别为83.5％和95.0％。总之，同时放化疗和尼莫妥单抗的耐受性良好，依从性良好。与同时放化疗联合西妥昔单抗的历史数据相比，初步的临床结果数据令人鼓舞，并且具有良好的正常组织毒性结果。没有观察到痤疮样皮疹。中位随访期为24.1个月，其2年无进展生存期和总生存期分别为83.5％和95.0％。总之，同时放化疗和尼莫妥单抗的耐受性良好，依从性良好。与同时放化疗联合西妥昔单抗的历史数据相比，初步的临床结果数据令人鼓舞，并且具有良好的正常组织毒性结果。