Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck
Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck
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DOI：
10.1056/nejmoa053422
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发表时间：
2006-02-09
影响因子：
158.5
通讯作者：
Ang, KK
中科院分区：
文献类型：
--
作者：
Bonner, JA;Harari, PM;Ang, KK
背景：我们进行了一项多国随机研究，比较放疗加西妥昔单抗（一种抗表皮生长因子受体的单克隆抗体）单独治疗局部晚期头颈部鳞状细胞癌的疗效。方法：局部晚期头颈部癌患者随机分为两组，一组仅接受大剂量放疗（213例），另一组接受大剂量放疗加每周一次西妥昔单抗（211例），初始剂量为每平方米体表面积400 mg，放疗期间每周一次，剂量为每平方米250 mg。主要终点是局部疾病控制的持续时间;次要终点是总生存期、无进展生存期、缓解率和safety.Results：局部控制的中位持续时间在接受西妥昔单抗联合放疗的患者中为24.4个月，在接受单纯放疗的患者中为14.9个月（局部疾病进展或死亡的风险比为0.68; P=0.005）。中位随访时间为54.0个月，联合治疗组患者的中位总生存期为49.0个月，单纯放疗组为29.3个月（死亡风险比为0.74; P=0.03）。放疗加西妥昔单抗显著延长了无进展生存期（疾病进展或死亡的风险比为0.70; P=0.006）。除了痤疮样皮疹和输液反应，3级或更高的毒性反应，包括粘膜炎的发生率，并没有显着差异，两组之间的CONCLUSIONS：治疗局部晚期头颈癌伴随高剂量放疗加西妥昔单抗提高局部控制和降低死亡率，而不增加常见的毒性反应与放疗的头部和颈部。
BACKGROUND:We conducted a multinational, randomized study to compare radiotherapy alone with radiotherapy plus cetuximab, a monoclonal antibody against the epidermal growth factor receptor, in the treatment of locoregionally advanced squamous-cell carcinoma of the head and neck.METHODS:Patients with locoregionally advanced head and neck cancer were randomly assigned to treatment with high-dose radiotherapy alone (213 patients) or high-dose radiotherapy plus weekly cetuximab (211 patients) at an initial dose of 400 mg per square meter of body-surface area, followed by 250 mg per square meter weekly for the duration of radiotherapy. The primary end point was the duration of control of locoregional disease; secondary end points were overall survival, progression-free survival, the response rate, and safety.RESULTS:The median duration of locoregional control was 24.4 months among patients treated with cetuximab plus radiotherapy and 14.9 months among those given radiotherapy alone (hazard ratio for locoregional progression or death, 0.68; P=0.005). With a median follow-up of 54.0 months, the median duration of overall survival was 49.0 months among patients treated with combined therapy and 29.3 months among those treated with radiotherapy alone (hazard ratio for death, 0.74; P=0.03). Radiotherapy plus cetuximab significantly prolonged progression-free survival (hazard ratio for disease progression or death, 0.70; P=0.006). With the exception of acneiform rash and infusion reactions, the incidence of grade 3 or greater toxic effects, including mucositis, did not differ significantly between the two groups.CONCLUSIONS:Treatment of locoregionally advanced head and neck cancer with concomitant high-dose radiotherapy plus cetuximab improves locoregional control and reduces mortality without increasing the common toxic effects associated with radiotherapy to the head and neck.