Department of Nasopharyngeal Carcinoma, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, Guangdong, People's Republic of China.
Department of Thoracic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, 510089, Guangdong, People's Republic of China.
J Cancer Res Clin Oncol. 2023 Jun;149(6):2327-2344. doi: 10.1007/s00432-022-04355-w. Epub 2022 Oct 27.
The efficacy and safety of nimotuzumab (NTZ) added to concurrent chemoradiotherapy (CCRT) were investigated in patients with stage III-IVa nasopharyngeal carcinoma (NPC).
Patients with stage III-IVa NPC treated with CCRT, with or without NTZ, were screened between January 2015 and December 2017. We compared patients' overall survival (OS), progression-free survival (PFS), locoregional recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) between different therapeutic regimens. Propensity score matching (PSM) was applied to reduce the selection bias. Nomogram models were developed to predict the survival of CCRT with or without NTZ.
Four hundred and twenty-six patients were included after PSM, with 213 patients in each regimen. Compared with NPC patients receiving CCRT alone, patients who received NTZ plus CCRT treatment had significantly better OS (5 year OS, 76.1 vs. 72.3%, P = 0.004), PFS (5 year PFS, 73.2 vs. 69.0%, P = 0.002), and LRFS (5 year LRFS, 73.2 vs. 69.0%, P = 0.028). A multivariate Cox regression analysis demonstrated that, compared with receiving CCRT alone, NTZ plus CCRT was an independently positive factor for OS, PFS, and LRFS. No significant difference was observed in the major toxicities between the two treatments (all P > 0.05). In addition, the nomogram presented good accuracy for predicting the prognosis of NPC patients.
CCRT combined with NTZ presented favorable clinical outcomes for stage III-IVa NPC patients with good tolerance and similar toxicity compared to CCRT alone. A prospective, randomized clinical trial is essential to validate the current findings.
研究尼妥珠单抗（NTZ）联合同期放化疗（CCRT）在 III-IVa 期鼻咽癌（NPC）患者中的疗效和安全性。
筛选 2015 年 1 月至 2017 年 12 月期间接受 CCRT 治疗且有或无 NTZ 治疗的 III-IVa NPC 患者。我们比较了不同治疗方案之间患者的总生存期（OS）、无进展生存期（PFS）、局部区域无复发生存期（LRFS）和无远处转移生存期（DMFS）。采用倾向评分匹配（PSM）以减少选择偏倚。建立列线图模型预测 CCRT 联合或不联合 NTZ 的生存情况。
PSM 后共纳入 426 例患者，每组 213 例。与单独接受 CCRT 的 NPC 患者相比，接受 NTZ 联合 CCRT 治疗的患者具有更好的 OS（5 年 OS，76.1%比 72.3%，P=0.004）、PFS（5 年 PFS，73.2%比 69.0%，P=0.002）和 LRFS（5 年 LRFS，73.2%比 69.0%，P=0.028）。多变量 Cox 回归分析表明，与单独接受 CCRT 相比，NTZ 联合 CCRT 是 OS、PFS 和 LRFS 的独立阳性因素。两种治疗方法的主要毒性之间无显著差异（均 P>0.05）。此外，列线图对 NPC 患者的预后预测具有较好的准确性。
与单独接受 CCRT 相比，CCRT 联合 NTZ 治疗 III-IVa 期 NPC 患者具有良好的耐受性和相似的毒性，可获得更好的临床疗效。有必要开展前瞻性、随机临床试验来验证当前的研究结果。
