Sun Xue-Song, Liang Yu-Jing, Li Xiao-Yun, Liu Sai-Lan, Chen Qiu-Yan, Tang Lin-Quan, Mai Hai-Qiang
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Centre, Guangzhou, People's Republic of China.
Department of Nasopharyngeal Carcinoma, State Key Laboratory of Oncology in South China, Guangzhou, People's Republic of China.
Drug Des Devel Ther. 2019 Sep 10;13:3207-3216. doi: 10.2147/DDDT.S215190. eCollection 2019.
We aimed to investigate the efficacy and safety of cetuximab (CTX) or nimotuzumab (NTZ) on the addition of palliative chemotherapy (PCT) in patients with de novo metastatic nasopharyngeal carcinoma (NPC).
From 2007 to 2016, 451 eligible patients with de novo metastatic NPC were enrolled in the study. With propensity score matching technique, we created a well-balanced cohort by matching patients who received CTX/NTZ plus PCT (62 patients) with those receiving PCT alone (248 patients) in a ratio of 1:4. The primary endpoint was overall survival (OS). All potential prognostic factors were involved in the multivariate analysis with the Cox regression hazards model. Kaplan-Meier curves were used to compare the survival status, and log-rank test to measure the significance.
The median follow-up time was 27.7 months (range, 1-126 months). No significant difference in survival was observed between the CTX/NTZ plus PCT group and PCT group. (3-year OS: 63.0% vs 58.1%; =0.485). The administration of CTX/NTZ was not found to be an independent prognostic factor in multivariate analysis. With regard to toxicity, the development of a G3-4 skin reaction and mucositis was more common in patients receiving CTX plus PCT. Interaction effects analysis did not show any significant interaction effects on OS between the treatment regimen and prognostic factors (>0.05).
The efficacy of CTX/NTZ and PCT is comparable to single PCT treatment in terms of survival outcomes among de novo metastatic NPC patients. Moreover, the application of CTX exacerbated skin reactions and mucositis.
我们旨在研究西妥昔单抗(CTX)或尼妥珠单抗(NTZ)联合姑息化疗(PCT)对初治转移性鼻咽癌(NPC)患者的疗效和安全性。
2007年至2016年,451例符合条件的初治转移性NPC患者纳入本研究。采用倾向评分匹配技术,我们以1:4的比例将接受CTX/NTZ联合PCT的患者(62例)与仅接受PCT的患者(248例)进行匹配,创建了一个均衡的队列。主要终点为总生存期(OS)。所有潜在的预后因素均纳入Cox回归风险模型进行多因素分析。采用Kaplan-Meier曲线比较生存状况,采用对数秩检验衡量其显著性。
中位随访时间为27.7个月(范围1-126个月)。CTX/NTZ联合PCT组与PCT组之间未观察到生存差异有统计学意义。(3年总生存率:63.0%对58.1%;P=0.485)。在多因素分析中,CTX/NTZ的使用并非独立的预后因素。关于毒性,接受CTX联合PCT的患者更常见发生3-4级皮肤反应和粘膜炎。交互作用分析未显示治疗方案与预后因素之间对OS有任何显著的交互作用(P>0.05)。
在初治转移性NPC患者的生存结局方面,CTX/NTZ联合PCT的疗效与单纯PCT治疗相当。此外,CTX的应用加剧了皮肤反应和粘膜炎。