Cetuximab for the treatment of colorectal cancer
Cetuximab for the treatment of colorectal cancer
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DOI：
10.1056/nejmoa071834
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发表时间：
2007-11-15
影响因子：
158.5
通讯作者：
Moore, Malcolm J.
中科院分区：
文献类型：
--
作者：
Jonker, Derek J.;O'Callaghan, Chris J.;Moore, Malcolm J.
背景：西妥昔单抗是一种针对表皮生长因子受体 (EGFR) 的 IgG1 嵌合单克隆抗体，对表达 EGFR 的结直肠癌具有活性。 方法：从 2003 年 12 月至 2005 年 8 月，对 572 名患有表达免疫组织化学可检测到的 EGFR 的结直肠癌且之前接受过氟嘧啶、伊立替康和 奥沙利铂或有这些药物治疗禁忌症的患者接受随机分组，初始剂量为每平方米体表面积 400 毫克西妥昔单抗，随后每周输注每平方米 250 毫克加最佳支持治疗（287 名患者）或单独最佳支持治疗（285 名患者）。主要终点是总生存期。 结果：与单独最佳支持治疗相比，西妥昔单抗治疗与总生存期（死亡风险比，0.77；95% 置信区间 [CI]，0.64 至 0.92；P=0.005）和无进展生存期（疾病进展或死亡风险比，0.68；95% CI，0.57 至 0.80；95% CI，0.57 至 0.80）显着改善相关。磷
Background: Cetuximab, an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor (EGFR), has activity against colorectal cancers that express EGFR.Methods: From December 2003 to August 2005, 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine, irinotecan, and oxaliplatin or had contraindications to treatment with these drugs underwent randomization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care (287 patients) or best supportive care alone (285 patients). The primary end point was overall survival.Results: In comparison with best supportive care alone, cetuximab treatment was associated with a significant improvement in overall survival (hazard ratio for death, 0.77; 95% confidence interval [CI], 0.64 to 0.92; P=0.005) and in progression-free survival (hazard ratio for disease progression or death, 0.68; 95% CI, 0.57 to 0.80; P