EGFR单克隆抗体在复发/转移头颈鳞癌中应用的Meta分析

Anti-EGFR monoclonal antibodies in recurrent and/or metastatic head and neck squamous cell carcinoma： a meta-analysis

目的 研究表皮生长因子受体单克隆抗体（EGFR-mAbs）治疗复发/转移头颈鳞癌的有效性和安全性.方法 检索数据库包括中国生物医学文献数据库（CBM）和外文的PubMed、Embase以及Cochrane数据库.分析EGFR-mAbs治疗复发/转移头颈鳞癌的总体反应率（ORR）、无进展生存（PFS）和总体生存（OS）情况.主要观察3～4级严重不良反应,包括总体不良反应、低钙血症、低镁血症、低钾血症、贫血、中性粒细胞减少、血小板减少、发热性中性粒细胞减少、血栓形成、皮肤反应、厌食、脱水、呕吐、腹泻、呼吸困难、肿瘤出血、口腔炎、肺炎等.结果评价采用相对危险度（RR）或风险比（HR）及其95％可信区间（CI）表示.结果 最终纳入5篇RCT研究,涉及复发/转移头颈鳞癌患者1 615例.EGFR-mAbs治疗复发/转移头颈鳞癌有效（ORR：RR=1.61,95％ CI：1.34～ 1.92,P＜0.001;PFS：HR =0.68,95％ CI：0.61 ～0.76,P＜0.001;OS：HR =0.84,95％ CI：0.75～0.95,P=0.004）.严重不良反应事件中,EGFR-mAbs治疗组较对照组更多出现皮肤反应（RR=14.65,95％ CI：7.26～29.55）、低镁血症（RR=3.86,95％ CI：2.32～6.43）、厌食（RR=2.45,95％ CI：1.19～5.07）、脱水（RR=1.89,95％CI：1.11 ～3.20）和血栓形成（RR=2.31,95％ CI：1.27～4.21）,而其他不良反应发生率在EGFR-mAbs治疗组与对照组之间差异均无统计学意义（均P＞0.05）.结论 EGFR-mAbs可改善复发/转移性头颈部鳞癌的疗效,但需密切关注皮肤反应、低镁血症等严重不良反应.

Objective To systematically review the literature regarding the effectiveness and adverse reaction of epidermal growth factor receptor-monoclonal antibodies （RGFR-mAbs） in improving the prognosis of R/M HNSCC so as to develop evidence-based recommendations for treatment.Methods Comprehensively searches were performed for the databases of CBM,PubMed,Embase and Cochrane to identify the published studies on the effect of RGFR-mAbs in recurrent and/or metastatic head and neck squamous carcinoma （R/M HNSCC） patients.Primary outcomes included overall survival （OS）,progression-free survival （PFS） and overall response rate （ORR）.And secondary outcomes included such severe adverse events （grade Ⅲ-Ⅳ） as neutropenia,anemia,thrombocytopenia,skin reactions,hypokalemia,vomiting and hypomagnesemia,etc.Results A meta-analysis was conducted for 5 randomized controlled trials involving a total of 1 615 patients.Pooled data suggested the efficacies of EGFR-mAbs in R/M HNSCC patients.And adding EGFR-mAbs to conventional therapy led to significantly improved efficacies for R/M HNSCC （ORR：RR =1.61,95% CI：1.34-1.92,P 〈0.001;PFS：HR =0.68,95% CI：0.61-0.76,P〈0.001;OS：HR=0.84,95%CI：0.75-0.95,P=0.004）.Adverse events were comparable between EGFR-mAbs and control groups,except for increased incidence in skin reactions,hypomagnesemia,anorexia,exsiccosis and thrombogenesis.Conclusions Existing randomized controlled trials support the efficacies of EGFR-mAbs for R/M HNSCC.During Mabs therapy,skin reactions and hypomagnesemia should be closely monitored.