Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck
Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck
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DOI：
10.1200/jco.2005.07.119
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发表时间：
2005-08-20
影响因子：
45.3
通讯作者：
Eckardt, A
中科院分区：
文献类型：
--
作者：
Baselga, J;Trigo, JM;Eckardt, A
目的评价抗表皮生长因子受体单克隆抗体西妥昔单抗（cetuximab）联合铂类化疗治疗铂类药物难治性复发或转移性头颈部鳞状细胞癌（SCCHN）的疗效和安全性（初始剂量为400 mg/m2，随后每周剂量为250 mg/m2），随后以相同的剂量和时间表进行铂类化疗，在进入研究之前记录疾病进展。基于独立阅读的评估，在意向治疗人群中的缓解率为10%，疾病控制率（完全缓解、部分缓解[PR]和疾病稳定）为53%。中位至进展时间和总生存期分别为85和183天;两者在达到PR的患者中最长（中位分别为203.5和294天）。治疗耐受性良好。最常见的西妥昔单抗相关的不良事件是皮肤反应，特别是痤疮样rush.Conclusion西妥昔单抗和铂化疗的组合是一个积极的和耐受性良好的方法来治疗这个预后不良的患者人群铂难治性复发或转移性SCCHN的人没有推荐的标准治疗方案。
Purpose To evaluate the efficacy and safety of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).Patients and Methods Ninety-six eligible patients received cetuximab (initial dose of 400 mg/m(2) followed by subsequent weekly doses of 250 mg/m(2)) followed by platinum chemotherapy at the same dose and schedule at which progressive disease was documented before entry onto the study.Results The response rate, based on an independently read assessment, in the intent-to-treat population was 10%, with a disease control rate (complete response, partial response [PR], and stable disease) of 53%. The median time to progression and overall survival were 85 and 183 days, respectively; both were longest in patients achieving a PR (median, 203.5 and 294 days, respectively). Treatment was well tolerated. The most common cetuximab-related adverse events were skin reactions, particularly an acne-like rash.Conclusion The combination of cetuximab and platinum chemotherapy is an active and well-tolerated approach to the treatment of this poor-prognosis patient population with platinum-refractory recurrent or metastatic SCCHN for whom there are no recommended standard therapeutic options.