BACKGROUND Nimotuzumab (NTZ) is an anti-EGFR monoclonal antibody. However,the effect of targeted drugs combined with induction therapy in locally advanced nasopharyngeal carcinoma remains unclear. The aim of this study is to investigate the safety and efficacy of NTZ combined with cisplatin plus 5-fluorouracil (PF) as induction regimen in locally advanced nasopharyngeal carcinoma (NPC) patients receiving concurrent radiochemotherapy. METHODS This was a multicenter randomized controlled study performed in eight Guangxi hospitals in 2015-2017. Eligible patients with NPC were randomized into nimotuzumab/PF (NPF group) and docetaxel/PF (DPF group) regimens, respectively, as induction therapy. After 2 cycles of induction therapy, all patients received cisplatin and concurrent intensity modulated radiation therapy (IMRT). Then, the two groups were compared for safety and efficacy. RESULTS A total of 118 patients with stage III-IVa NPC were assessed, with 58 and 60 in the NPF and DPF groups, respectively. Compared with DPF treatment, NPF induction therapy showed a more pronounced effect on cervical lymph nodes (P = 0.036), with higher response rate (RR) (81% vs 60%). Compared with the DPF group, the NPF group showed significantly reduced leukopenia, neutropenia and gastrointestinal reactions (all P < 0.05); rash only appeared in the NPF group, but all cases were grade 1. During concurrent treatment with radiotherapy and chemotherapy, the NPF group showed better tolerance to radiotherapy and chemotherapy; neutropenia, anemia, gastrointestinal reactions, oral mucositis and radiation dermatitis in the NPF group were significantly reduced (P < 0.05). The expression rate of EGFR was 94.9% (112/118). Compared with the DPF group, patients with EGFR expression in the NPF group showed better response (77.8% vs 63.0%, P = 0.033). CONCLUSION For locally advanced NPC patients receiving follow-up cisplatin and IMRT, nimotuzumab/PF for induction therapy has better lymph node response rate and milder adverse reactions than the DPF regimen. In addition, the patients have better tolerance in subsequent concurrent radiotherapy and chemotherapy; however, long-term efficacy needs further follow-up evaluation. TRIAL REGISTRATION The registration number of the clinical trial is ChiCTR-OIC-16008201 and retrospectively registered on March 31, 2016.

中文翻译：

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尼莫妥单抗联合顺铂加5-氟尿嘧啶的诱导治疗可改善接受同步放疗的局部晚期鼻咽癌患者的治疗反应和耐受性：一项多中心随机对照研究。

背景技术Nimotuzumab（NTZ）是一种抗EGFR单克隆抗体。然而，靶向药物联合诱导治疗在局部晚期鼻咽癌中的作用仍不清楚。这项研究的目的是研究NTZ联合顺铂加5-氟尿嘧啶（PF）作为局部同时接受放化疗的晚期鼻咽癌（NPC）患者的诱导方案的安全性和有效性。方法这是一项2015年至2017年在广西八家医院进行的多中心随机对照研究。符合条件的NPC患者被随机分为尼莫妥珠单抗/ PF（NPF组）和多西他赛/ PF（DPF组）作为诱导疗法。经过2个周期的诱导治疗后，所有患者均接受顺铂和同时调强放射治疗（IMRT）。然后，比较两组的安全性和有效性。结果共评估了118例III-IVa期NPC患者，其中NPF和DPF组分别为58和60。与DPF治疗相比，NPF诱导治疗对宫颈淋巴结有更明显的作用（P = 0.036），有较高的缓解率（RR）（81％vs 60％）。与DPF组相比，NPF组白细胞减少，中性粒细胞减少和胃肠道反应显着降低（均P <0.05）。皮疹仅在NPF组中出现，但所有病例均为1级。在同时进行放，化疗的过程中，NPF组对放，化疗具有更好的耐受性。NPF组的中性粒细胞减少症，贫血，胃肠道反应，口腔粘膜炎和放射性皮炎明显减少（P <0.05）。EGFR的表达率为94.9％（112/118）。与DPF组相比，NPF组中EGFR表达患者表现出更好的反应（77.8％vs 63.0％，P = 0.033）。结论对于接受顺铂和IMRT随访的局部晚期NPC患者，尼莫妥珠单抗/ PF诱导治疗比DPF方案具有更好的淋巴结反应率和较轻的不良反应。另外，患者在随后的同时放疗和化疗中具有更好的耐受性；但是，长期疗效需要进一步的随访评估。试验注册该临床试验的注册号为ChiCTR-OIC-16008201，并于2016年3月31日进行追溯注册。结论对于接受顺铂和IMRT随访的局部晚期NPC患者，尼莫妥珠单抗/ PF诱导治疗比DPF方案具有更好的淋巴结反应率和较轻的不良反应。另外，患者在随后的同时放疗和化疗中具有更好的耐受性；但是，长期疗效需要进一步的随访评估。试验注册该临床试验的注册号为ChiCTR-OIC-16008201，并于2016年3月31日进行追溯注册。结论对于接受顺铂和IMRT随访的局部晚期NPC患者，尼莫妥珠单抗/ PF诱导治疗比DPF方案具有更好的淋巴结反应率和较轻的不良反应。另外，患者在随后的同时放疗和化疗中具有更好的耐受性；但是，长期疗效需要进一步的随访评估。试验注册该临床试验的注册号为ChiCTR-OIC-16008201，并于2016年3月31日进行回顾性注册。长期疗效需要进一步的随访评估。试验注册该临床试验的注册号为ChiCTR-OIC-16008201，并于2016年3月31日进行追溯注册。长期疗效需要进一步的随访评估。试验注册该临床试验的注册号为ChiCTR-OIC-16008201，并于2016年3月31日进行追溯注册。