EGFR单克隆抗体在局部晚期头颈鳞状细胞癌中应用的Meta分析  

Anti-EGFR monoclonal antibodies in locally advanced head and neck squamous cell carcinoma:a Meta-analysis

作　　者：宋琦[1] 李晓明[2] 李彬[3] 邸斌[2] 肖淑芬[2] 

机构地区：[1]解放军总医院(解放军医学院),北京100853 [2]白求恩国际和平医院耳鼻咽喉头颈外科 [3]石家庄市第一医院重症监护二科

出　　处：《临床耳鼻咽喉头颈外科杂志》2015年第9期815-821,共7页Journal of Clinical Otorhinolaryngology Head And Neck Surgery

基　　金：河北省基础研究重点项目(No:14967221D)

摘　　要：目的：探讨表皮生长因子受体（EGFR）单克隆抗体（Mabs）治疗局部晚期头颈鳞状细胞癌的有效性和安全性。方法：检索数据库包括中文CBM和外文PUBMED、EMBASE以及CENTRAL。分析指标为总体反应率（ORR）、无进展生存情况（PFS）和总体生存情况（OS）。不良反应主要观察指标为3∽4级严重不良反应,主要包括皮肤反应、咽下困难、黏膜炎以及恶心（呕吐）等。评价结果使用相对危险度（RR）或风险比（HR）及其相应95%CI表示。结果：最终纳入研究对象包含10篇RCT试验的头颈鳞状细胞癌患者。单克隆抗体不提高局部晚期头颈鳞状细胞癌患者的ORR和PFS,对OS有改善[ORR 1.21,95%CI（0.97∽1.49）;PFS 0.87,95%CI（0.75∽1.01）;OS 0.82,95%CI（0.71∽0.95）]。严重不良反应事件中,3∽4级皮肤反应与单克隆抗体治疗有密切关系[RR 1.87,95%CI（1.11∽3.16）],其他如咽下困难[RR 0.95,95%CI（0.75∽1.19）],黏膜炎[RR1.03,95%CI（0.67∽1.57）]以及恶心（呕吐）[RR 1.15,95%CI（0.71∽1.86）]在2组间差异无统计学意义。结论：EGFR单克隆抗体延长局部晚期头颈鳞状细胞癌OS,具有一定治疗效果。3∽4级皮肤反应是与EGFR-Mabs治疗有关的严重不良反应。Objective：To perform a Meta-analysis of all randomized controlled trials that compared the efficacy and adverse events profile of Mabs for LA HNSCC. Method.. Several databases were searched, including CBM, PUBMED, EMBASE, and CENTRAL. Primary outcomes included overall response rate （ORR）, overall survival （OS）, progression-free survival （PFS）. Secondary outcomes included serious adverse events, such as grade 3--4 skin reaction, dysphagia, mucositis, and nausea/vomiting. The results were expressed as relative ratio （RR） or hazard rate （HR） with their corresponding 95 % CI. Result：The final analysis included 10 trials. The primary analy- ses indicated that Mabs did not improve ORR and PFS, except OS for locoregionally advanced （LA） HNSCC [ORR1.21, 95% CI （0. 97--1. 49） ; PFS 0.87,95% CI （0.75--1.01）; OS 0.82, 95% CI （0.71--0.95）-]. Analysis of adverse effects demonstrated that grade 3--4 skin reaction [RR 1.87, 95% CI （1.11--3.16）] was statistically significantly associated with Mabs except dysphagia [RR 0.95, 95% CI （0.75--1.19）], Mucositis ERR 1.03, 95%CI （0.67--1.57）], and nausea/vomiting [RR 1.15, 95% CI （0.71--1.86）]. Conclusion;Anti- EGFR Mabs may be satisfactory for improving OS of LA HNSCC. During the Mabs therapy, skin reaction should be much more monitored.

关 键 词：表皮生长因子受体 单克隆抗体 局部晚期头颈鳞状细胞癌 META分析 

分 类 号：R739.6[医药卫生—肿瘤]