Song Qi, Li Xiaoming, Li Bin, Di Bin, Xiao Shufen
Department of Otorhinolaryngology Head & Neck Surgery, Bethune International Peace Hospital of PLA, Shijiazhuang 050082, China.
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Zhonghua Yi Xue Za Zhi. 2015 Jun 9;95(22):1779-83.
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.
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.
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.
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.
系统回顾表皮生长因子受体单克隆抗体(RGFR-mAbs)改善复发/转移性头颈部鳞状细胞癌(R/M HNSCC)预后的有效性及不良反应,以制定循证治疗建议。
全面检索中国生物医学文献数据库(CBM)、PubMed、Embase和Cochrane数据库,以识别已发表的关于RGFR-mAbs对复发和/或转移性头颈部鳞状细胞癌(R/M HNSCC)患者疗效的研究。主要结局包括总生存期(OS)、无进展生存期(PFS)和总缓解率(ORR)。次要结局包括中性粒细胞减少、贫血、血小板减少、皮肤反应、低钾血症、呕吐和低镁血症等严重不良事件(III-IV级)。
对5项随机对照试验进行荟萃分析,共纳入1615例患者。汇总数据表明EGFR-mAbs对R/M HNSCC患者有效。在传统治疗中添加EGFR-mAbs可显著提高R/M HNSCC的疗效(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)。除皮肤反应、低镁血症、厌食、脱水和血栓形成发生率增加外,EGFR-mAbs组与对照组的不良事件相当。
现有随机对照试验支持EGFR-mAbs对R/M HNSCC的疗效。在单克隆抗体治疗期间,应密切监测皮肤反应和低镁血症。