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首页> 外文期刊>Journal of Clinical Oncology >Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma.
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Multicenter, phase II study of cetuximab in combination with carboplatin in patients with recurrent or metastatic nasopharyngeal carcinoma.

机译：西妥昔单抗联合卡铂在复发或转移性鼻咽癌患者中的多中心II期研究。

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PURPOSE: To evaluate efficacy and toxicity of cetuximab plus carboplatin in recurrent or metastatic nasopharyngeal carcinoma (NPC) resistant to platinum treatment. PATIENTS AND METHODS: A multicenter, open-label, single-arm, phase II study in patients with epidermal growth factor receptor-expressing NPC who progressed on or within 12 months after termination of platinum-based chemotherapy for recurrent or metastatic disease. Cetuximab was administered at an initial dose of 400 mg/m2 followed by weekly doses of 250 mg/m2. Carboplatin area under the curve 5 was administered every 3 weeks up to a maximum of eight cycles. RESULTS: Sixty patients were enrolled (46 males, 14 females; median age, 44.5 years; range, 23 to 64 years), and all patients were included in the intent-to-treat and safety analyses. Of the 59 patients assessable for efficacy, there were seven partial responses (11.7%), 29 patients (48.3%) with stable disease, and 23 patients (38.3%) with progressive disease, giving an overall response rate of 11.7% (95% CI, 4.8% to 22.6%). The median time to progression was 81 days in all patients and was longest in the group of patients with a confirmed response (173 days). The median overall survival time was 233 days in all patients. Six patients (10%) experienced serious treatment-related adverse events. Grade 3 or 4 toxicities occurred in 31 patients (51.7%); of these patients, only 19 (31.7%) were considered to have toxicity related to cetuximab. CONCLUSION: Cetuximab in combination with carboplatin demonstrates clinical activity and an acceptable safety profile in heavily pretreated patients with recurrent or metastatic NPC who had previously experienced treatment failure with platinum-based therapy.
机译：目的：评估西妥昔单抗联合卡铂在对铂治疗耐药的复发或转移性鼻咽癌（NPC）中的疗效和毒性。病人和方法：一项多中心，开放性，单臂，II期临床研究针对表皮生长因子受体表达NPC的患者，该患者在铂类化疗终止或复发或转移性疾病后12个月内进展。西妥昔单抗的初始剂量为400 mg / m2，随后每周剂量为250 mg / m2。每3周施用曲线5下的卡铂区域，最多八个周期。结果：招募了60例患者（男46例，女14例;中位年龄44.5岁;范围23到64岁），所有患者均纳入治疗意向和安全性分析。在可评估疗效的59例患者中，有7例部分缓解（11.7％），29例（48.3％）稳定的疾病和23例患者（38.3％）进行性疾病，总缓解率为11.7％（95％） CI，4.8％至22.6％）。在所有患者中，进展时间的中位数为81天，在确诊的患者中最长（173天）。所有患者的平均总生存时间为233天。 6名患者（10％）经历了与治疗相关的严重不良事件。 31例患者发生了3或4级毒性反应（51.7％）;在这些患者中，只有19（31.7％）被认为具有西妥昔单抗相关的毒性。结论：西妥昔单抗联合卡铂显示出在先前接受过铂类疗法治疗失败的复发或转移性鼻咽癌严重重症患者中的临床活性和可接受的安全性。

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