西妥昔单抗联合同期顺铂化疗加调强放疗局部晚期鼻咽癌的安全性研究

目的 通过开放性、多中心临床研究探讨西妥昔单抗联合同期顺铂化疗加调强放疗(IMRT)局部晚期鼻咽癌的安全性。方法 100例Ⅲ~Ⅳ_b期初治鼻咽癌患者入组,IMRT处方剂量鼻咽原发灶 66.0~75.9 Gy,颈部阳性淋巴结 60~70 Gy;同期顺铂化疗剂量80 mg/m²(每3周);西妥昔单抗首剂400 mg/m²(放疗前,第1周),其后250 mg/m²(每周)。按不良反应常见术语标准3.0版评价这一联合方案的不良反应。结果 全组患者治疗依从性良好。鼻咽原发灶大体肿瘤体积实际中位剂量为69.96 Gy,颈部阳性淋巴结大体肿瘤体积为68 Gy。同期顺铂中位剂量为133 mg/疗程;西妥昔单抗中位起始剂量为690 mg,中位维持剂量为410 mg/周。治疗期间主要不良反应为痤疮样皮疹、口腔黏膜炎以及放射性皮炎,其中1级放射性皮炎及>2级口腔黏膜炎分别占58%、90%,2%患者出现4级口腔黏膜炎。骨髓抑制较为轻微,仅分别有8%、4%和5%患者出现>2级中性粒细胞减少、血小板降低和贫血。结论 西妥昔单抗联合同期顺铂化疗加调强放疗局部晚期鼻咽癌的患者依从性好,不良反应可耐受。

Multicenter safety study on cetuximab combined with intensity modulated radiotherapy and concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma

Objective To evaluate the safety of cetuximab combined with intensity-modulated radiotherapy (IMRT) plus concurrent cisplatin chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC) in a Chinese multicenter clinical study. Methods From July 2008 to April 2009, 100 Patients with primary stage Ⅲ－Ⅳ_b non-keratinizing NPC were enrolled. The planned dose of IMRT to gross tumor volume and positive cervical lymph nodes was 66.0－75.9 Gy and 60－70 Gy in 30－33 fractions. Cisplatin (80 mg/m², q3 week (w)) and cetuximab (400 mg/m² one w before radiation, and then 250 mg/m² per w) were given concurrently. The adverse events (AEs) were graded according to common terminology criteria for adverse events v3.0. Results The compliance of the entire group of patient was satisfactory. Actual median dose to gross tumor volume was 69.96 Gy, and the median dose to positive cervical lymph nodes was 68 Gy. Median dose of cisplatin was 133 mg, median first-dose of cetuximab was 690 mg, and median weekly dose was 410 mg. AEs were well tolerated and manageable, mainly consisting of acneiform skin eruptions, dermatitis and mucositis. Grade 4 mucositis was observed in 2% of the patients and no other grade 4 AEs were observed. Conclusions The combined treatment modality of IMRT+concurrent chemotherapy+cetuximab in loco-regionally advanced NPC is well tolerated.