表皮生长因子受体单克隆抗体在结直肠癌治疗中作用的系统评价

背景：研究表明表皮生长因子受体（EGFR）信号通路可调节细胞的分化、增殖、迁移、凋亡以及血管发生。近年来，靶向EGFR的单克隆抗体拓宽了结直肠癌治疗的选择范围。目的：系统评价EGFR单抗联合结直肠癌治疗方案在结直肠癌治疗中的疗效和安全性。方法：从常用电子数据库中检索结直肠癌治疗方案联合与未联合EGFR单抗治疗结直肠癌的随机对照试验，分析反应率和不良反应发生率的合并比值比（OR），行亚组分析和敏感性分析，以漏斗图检测出版偏倚。结果：共7项随机对照试验（n=4186）纳入分析。联合与未联合EGFR单抗（治疗组和对照组）的反应率按意向治疗（ITT）分析分别为25．4％和17．6％（OR3．36，95％CI：1．42～7．95），按方案（PP）分析分别为25．6％和18．0％（OR3．32，95％CI：1．40～7．88）．治疗组反应率明显优于对照组；两组3级以上不良反应总体发生率按ITT分析分别为71．2％和54.3％（OR2．23．95％CI：1．74～2．86）．治疗组3级以上不良反应总体发生率和皮肤损害、腹泻、低镁血症发生率均高于对照组。结论：EGFR单抗可明显提高结直肠癌，尤其是转移性或进展期结直肠癌患者对治疗的反应率，伴3级以上不良反应发生率增高。

Effect of Monoclonal Antibody Targeting Epidermal Growth Factor Receptor in the Treatment of Colorectal Cancer: A Systematic Review

Background： Many studies indicated that the epidermal growth factor receptor （EGFR） signaling pathway regulated cell differentiation, proliferation, migration, apoptosis and angiogenesis. The recent successful development of monoclonal antibodies targeting EGFR （EGFR-mAb） has expanded the treatment options for colorectal cancer （CRC）. Aims： To systematically evaluate the efficacy and safety of EGFR-mAb when added to therapeutic regimens in the treatment of CRC. Methods： Eligible articles relevant to the topic were identified by searching the frequently used database. All randomized controlled trials comparing the arm with EGFR-mAb to the arm without EGFR-mAb during the treatment of CRC were included. Summary odds ratio （OR） of response rate and incidence of adverse events were analyzed. Subgroup- analysis and sensitivity analysis were also performed. The publication bias was tested by funnel plot. Results： Seven randomized controlled trials （n=4186） were identified. Pooled response rate to therapeutic regimen in patients with and without EGFR-mAb （treated group and control group） by intention-to-treat （ITT） analysis was 25.4% and 17.6%, respectively （OR 3.36, 95% CI： 1.42-7.95）, and by per protocol （PP） analysis was 25.6% and 18.0%, respectively （OR 3.32, 95% CI： 1.40-7.88）. Response rate of treated group was superior to that of the control group. Pooled incidence of grade 3-4 adverse events of the treated group by ITI＇ analysis was higher than that of the control group （71.2% vs. 54.3%, OR 2.23, 95% CI 1.74-2.86）, so did the occurrence rates of skin lesions, diarrhea, and hypomagnesemia. Conclusions： EGFR-mAb increases significantly the response rate to therapeutic regimen in patients with CRC, especially the metastatic/ advanced CRC, associated with a moderate increase of grade 3-4 adverse events.