Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer
Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer
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DOI：
10.1056/nejmoa033025
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发表时间：
2004-07-22
影响因子：
158.5
通讯作者：
Van Cutsem, E
中科院分区：
文献类型：
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作者：
Cunningham, D;Humblet, Y;Van Cutsem, E
背景：表皮生长因子受体（epidermal growth factor receptor， EGFR）在结肠癌细胞中经常出现，它参与癌细胞中失调的信号通路。西妥昔单抗是一种特异性阻断EGFR的单克隆抗体。我们比较了西妥昔单抗联合伊立替康与西妥昔单抗在伊立替康治疗难治性转移性结直肠癌中的疗效。方法：我们随机分配329例在伊立替康为基础的方案治疗期间或治疗后3个月内病情进展的患者，接受西妥昔单抗和伊立替康（剂量和方案与研究前方案相同[218例患者]）或西妥昔单抗单药治疗（111例患者）。在疾病进展的情况下，允许在西妥昔单抗单药治疗中添加伊立替康。对患者的肿瘤反应进行放射学评估，并对肿瘤进展时间、生存时间和治疗副作用进行评估。结果：联合治疗组有效率明显高于单药治疗组（22.9%[95%可信区间，17.5 ~ 29.1%]vs. 10.8%[95%可信区间，5.7 ~ 18.1%]，P=0.007）。联合治疗组的中位进展时间明显更长(4.1个月vs. 1.5个月，P
Background: The epidermal growth factor receptor (EGFR), which participates in signaling pathways that are deregulated in cancer cells, commonly appears on colorectal-cancer cells. Cetuximab is a monoclonal antibody that specifically blocks the EGFR. We compared the efficacy of cetuximab in combination with irinotecan with that of cetuximab alone in metastatic colorectal cancer that was refractory to treatment with irinotecan.Methods: We randomly assigned 329 patients whose disease had progressed during or within three months after treatment with an irinotecan-based regimen to receive either cetuximab and irinotecan (at the same dose and schedule as in a prestudy regimen [218 patients]) or cetuximab monotherapy (111 patients). In cases of disease progression, the addition of irinotecan to cetuximab monotherapy was permitted. The patients were evaluated radiologically for tumor response and were also evaluated for the time to tumor progression, survival, and side effects of treatment.Results: The rate of response in the combination-therapy group was significantly higher than that in the monotherapy group (22.9 percent [95 percent confidence interval, 17.5 to 29.1 percent] vs. 10.8 percent [95 percent confidence interval, 5.7 to 18.1 percent], P=0.007). The median time to progression was significantly greater in the combination-therapy group (4.1 vs. 1.5 months, P