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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
引用本文:聂芳,沈骏,徐锡涛,朱明明,童锦禄,冉志华. 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[J]. 胃肠病学, 2009, 14(7): 388-393. DOI: 10.3969/j.issn.1008-7125.2009.07.002
作者姓名:聂芳  沈骏  徐锡涛  朱明明  童锦禄  冉志华
作者单位:上海交通大学医学院附属仁济医院消化内科,上海市消化疾病研究所,200001
摘    要: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。

关 键 词:受体  表皮生长因子  抗体  单克隆  结直肠肿瘤  靶向治疗

Effect of Monoclonal Antibody Targeting Epidermal Growth Factor Receptor in the Treatment of Colorectal Cancer: A Systematic Review
NIE Fang,SHEN Jun,XU Xitao,ZHU Mingming,TONG Jinlu,RAN Zhihua. Effect of Monoclonal Antibody Targeting Epidermal Growth Factor Receptor in the Treatment of Colorectal Cancer: A Systematic Review[J]. Chinese Journal of Gastroenterology, 2009, 14(7): 388-393. DOI: 10.3969/j.issn.1008-7125.2009.07.002
Authors:NIE Fang  SHEN Jun  XU Xitao  ZHU Mingming  TONG Jinlu  RAN Zhihua
Affiliation:(Department of Gastroenterology, Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai Institute of Digestive Disease, Shanghai (200001) Correspondence to: RAN Zhihua, Emaih z-ran@online.sh.cn )
Abstract: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.
Keywords:Receptor, Epidermal Growth Factor  Antibodies, Monoclonal  Colorectal Neoplasms  Targeted Therapy
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