尼妥珠单抗治疗局部晚期头颈部肿瘤疗效与安全性meta分析

A meta-analysis of efficacy and safety of nimotuzumab-containing regimens for locally advanced head and neck tumors

目的探讨尼妥珠单抗用于治疗局部晚期头颈部肿瘤的疗效和安全性。方法检索文献数据库(Cochrane Library、PubMed、Embase、万方数据库、中国知网)中尼妥珠单抗用于局部晚期头颈部肿瘤的随机对照试验(RCT)进行荟萃分析。有效性评价指标为总生存(OS)期、无进展生存(PFS)期、无瘤生存(DFS)期、客观缓解率(ORR)与完全缓解率(CRR),安全性评价指标为药物不良反应。纳入研究结果间的异质性分析采用卡方检验,异质性程度以I2指标评价,所有纳入的文献采用随机效应模型进行统计分析。结果共纳入11项RCT,共计1202例患者,尼妥珠单抗干预组602例,对照组600例。与常规治疗相比,增加尼妥珠单抗的干预组可延长OS期,降低死亡风险22%(HR=0.78,95%CI为0.63~0.95,P=0.014),延长PFS期,降低进展风险35%(HR=0.65,95%CI为0.53~0.81,P<0.01),延长DFS期,降低复发风险29%(HR=0.71,95%CI为0.55~0.91,P<0.01),显著改善ORR(RR=1.37,95%CI为1.20~1.55,P<0.01)和CRR(RR=1.30,95%CI为1.15~1.46,P<0.01)。安全性方面,增加尼妥珠单抗并未增加不良反应(RR=0.98,95%CI为0.93~1.03,P=0.410)。结论尼妥珠单抗可有效治疗局部晚期头颈部肿瘤,改善长期生存与近期疗效,安全性好。

Objective To evaluate the efficacy and safety of nimotuzumab in the treatment of advanced head and neck tumors by using meta-analysis.Methods Randomized controlled trials(RCT)of locally advanced head and neck squamous cell carcinoma(LA-HNSCC)treated with nimotuzumab were searched from databases(Cochrane Library,PubMed,Embase,Wanfang Data and CNKI)for meta-analysis.The efficacy evaluation indexes included overall survival,progression-free survival,disease-free survival,objective response rate,and complete response rate.Adverse reactions were analyzed for safety evaluation.The heterogeneity results were evaluated by Chi-square test,the degree of heterogeneity was evaluated by I2,and the literature was statistically analyzed by random effects model.Results A total of 11 RCT were included,consisting of 1202 patients(602 in the intervention group and 600 in the control group).Compared with the control group,the overall survival was significantly prolonged,death risk was decreased by 22%(HR=0.78,95%CI=0.63-0.95,P=0.014),the progression-free survival was prolonged and the risk of disease progression was declined by 35%(HR=0.65,95%CI=0.53-0.81,P<0.01),and the disease-free survival was prolonged and the risk of recurrence was decreased by 29%(HR=0.71,95%CI=0.55-0.91,P<0.01),the objective response rate(RR=1.37,95%CI=1.20-1.55,P<0.01)and complete response rate(RR=1.30,95%CI=1.15-1.46,P<0.01)were significantly improved in the intervention group.In addition,adding nimotuzumab did not increase the incidence of adverse reaction(RR=0.98,95%CI=0.93-1.03,P=0.41).Conclusion Nimotuzumab can significantly prolong long-term survival and improve short-term efficacy with high safety in LA-HNSCC patients.