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首页> 外文期刊>The New England journal of medicine >Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck.
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Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck.

机译：放射治疗加西妥昔单抗治疗头颈部鳞状细胞癌。

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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. (ClinicalTrials.gov number, NCT00004227.)
机译：背景：我们进行了一项多国随机研究，比较单独放疗与放疗加西妥昔单抗（一种针对表皮生长因子受体的单克隆抗体）在局部区域晚期头颈部鳞状细胞癌中的治疗。方法：将局部局部晚期头颈癌患者随机分配为单独接受大剂量放疗（213例）或大剂量放疗加每周西妥昔单抗（211例）的治疗，初始剂量为每平方米人体400毫克，表面积，然后在放疗期间每周每平方米250 mg。主要终点是控制局部疾病的持续时间。次要终点是总生存期，无进展生存期，缓解率和安全性。结果：西妥昔单抗联合放疗的患者局部区域控制的中位时间为24.4个月，单独接受放疗的患者为14.9个月（局部区域进展或死亡的危险比为0.68; P = 0.005）。中位随访期为54.0个月，接受联合治疗的患者的总生存中位时间为49.0个月，仅接受放疗的患者为29.3个月（死亡风险比为0.74; P = 0.03）。放疗联合西妥昔单抗可显着延长无进展生存期（疾病进展或死亡的危险比，0.70; P = 0.006）。除痤疮样皮疹和输注反应外，两组之间的3级或更高毒性反应（包括粘膜炎）的发生率无显着差异。结论：伴随高剂量放疗联合西妥昔单抗治疗局部区域晚期头颈癌可改善局部区域控制并降低死亡率，而不会增加与头颈部放射治疗相关的常见毒性作用。 （ClinicalTrials.gov编号，NCT00004227。）

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