OBJECTIVE This study aimed to evaluate the safety and efficacy of intensity-modulated radiotherapy (IMRT) plus nimotuzumab with or without concurrent chemotherapy (CCT) for patients with locally advanced nasopharyngeal carcinoma (LA-NPC). PATIENTS AND METHODS A total of 50 newly diagnosed patients with LA-NPC treated at the Affiliated Hospital of Jiangnan University between November 2011 and January 2017 were retrospectively analyzed. All patients received the combined treatment modality of nimotuzumab plus IMRT. Nimotuzumab was administered concurrently with IMRT at a weekly dose of 200 mg. Neoadjuvant, concurrent or adjuvant chemotherapy with the doublet regimen of taxanes (docetaxel or paclitaxel) plus platinum (cisplatin or nedaplatin) were administered. Among the 50 patients, 43 (86.0%) received ≥6 cycles of nimotuzumab (median 7 cycles, range 2-14 cycles) and 29 (58.0%) received two cycles of CCT with docetaxel plus nedaplatin. RESULTS With a median follow-up of 28.0 months, the 2-year progression-free survival (PFS) and overall survival were 83.29% (95% confidence interval [CI]: 67.93%-91.72%) and 97.67% (95% CI: 84.62%-99.67%), respectively. Both univariate and multivariate analyses revealed that cycles of nimotuzumab were significantly associated with PFS. Patients who received ≥6 cycles of nimotuzumab showed a better PFS than those receiving <6 cycles (P=0.006), whereas the addition of CCT failed to improve PFS. Oral mucositis was the most common adverse event, which was recorded as grade 3-4 in 18 (36.0%) patients. Besides, two (4.0%) patients experienced nimotuzumab-related anaphylaxis, and no skin rash was found in any patient. Subgroup analysis revealed that the patients who received CCT had more grade 3-4 adverse events as compared to those who did not receive CCT (62.1% vs 33.3%, P=0.045). CONCLUSION The regime of nimotuzumab plus IMRT for the treatment of LA-NPC was well tolerated, with encouraging survival data, and it could be an effective treatment alternative for patients with LA-NPC. Further clinical trials are needed to confirm these findings.

中文翻译：

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局部晚期鼻咽癌患者的调强放疗加尼妥珠单抗联合或不联合同步化疗。

目的 本研究旨在评估调强放疗 (IMRT) 联合尼妥珠单抗联合或不联合同步化疗 (CCT) 治疗局部晚期鼻咽癌 (LA-NPC) 患者的安全性和有效性。患者与方法 回顾性分析2011年11月至2017年1月在江南大学附属医院收治的50例新诊断的LA-NPC患者。所有患者均接受尼妥珠单抗联合调强放疗的联合治疗方式。Nimotuzumab 与 IMRT 同时给药，每周剂量为 200 mg。给予紫杉烷类（多西他赛或紫杉醇）加铂（顺铂或奈达铂）双重方案的新辅助、同步或辅助化疗。50 例患者中，43 例（86.0%）接受≥6 周期尼妥珠单抗治疗（中位数 7 周期，范围 2-14 周期）和 29 例（58.0%）接受了两个周期的 CCT 与多西他赛加奈达铂。结果 中位随访时间为 28.0 个月，2 年无进展生存期（PFS）和总生存期分别为 83.29%（95% 置信区间 [CI]：67.93%-91.72%）和 97.67%（95% CI : 84.62%-99.67%)。单变量和多变量分析均显示尼妥珠单抗周期与 PFS 显着相关。接受≥6 个周期尼妥珠单抗的患者比接受<6 个周期的患者显示出更好的 PFS（P=0.006），而添加 CCT 未能改善 PFS。口腔黏膜炎是最常见的不良事件，在 18 名 (36.0%) 患者中记录为 3-4 级。此外，2名（4.0%）患者出现尼妥珠单抗相关过敏反应，所有患者均未发现皮疹。亚组分析显示，与未接受 CCT 的患者相比，接受 CCT 的患者发生更多 3-4 级不良事件（62.1% vs 33.3%，P=0.045）。结论 尼妥珠单抗联合 IMRT 治疗 LA-NPC 的方案耐受性良好，生存数据令人鼓舞，可作为 LA-NPC 患者的有效治疗选择。需要进一步的临床试验来证实这些发现。