Phase II trial of cetuximab in patients with previously treated non-small-cell lung cancer
Phase II trial of cetuximab in patients with previously treated non-small-cell lung cancer
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DOI：
10.1200/jco.2006.08.2263
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发表时间：
2006-11-20
影响因子：
45.3
通讯作者：
Bonomi, Philip
中科院分区：
文献类型：
--
作者：
Hanna, Nasser;Lilenbaum, Rogerio;Bonomi, Philip
PurposeTo determine the efficacy of cetuximab in patients with recurrent or progressive non-small cell lung cancer（NSCLC）after receiving at least one prior chemotherapy regimen.Patients and MethodsThis is an open-label，phase II study of patients with epidermal growth factor receptor（EGFR）-positive and EGFR-negative advanced NSCLC with Eastern Cooperative Oncology Group performance status 0 to 1.患者在第1周接受西妥昔单抗400 mg/m2静脉注射（IV），持续120分钟，随后每周接受西妥昔单抗250 mg/m2静脉注射，持续60分钟。一个周期被认为是4周的治疗，治疗持续到疾病进展或不可耐受的毒性。主要终点是评估缓解率。次要终点包括估计的时间进展和survival.ResultsPatient和疾病特征（n = 66），包括EGFR阳性状态（n = 60）; EGFR阴性状态（n = 6）;既往治疗方案的数量（1，n = 28; 2，n = 27; 1，n = 28）; 2，n = 28; 3，n = 27; 4，n = 28; 5，n = 28; 6，n = 28; 7，n = 27; 10，n = 28; 10，n 3例，n = 11）;男性（n = 41）;女性（n = 25）;腺癌（n = 36）和吸烟状态（从不，13例;以前，n = 45;目前，8例）。3/4级毒性包括痤疮样皮疹（6.1%）、过敏反应（1.5%）和腹泻（1.5%）。所有患者（n = 66）的缓解率为4.5%（95% CI，0.9%至12.7%），疾病稳定率为30.3%（95% CI，19.6%至42.9%）。EGFR阳性肿瘤患者（n = 60）的缓解率为5%（95% CI，1.0%-13.9%）。所有患者的中位进展时间为2.3个月（95% CI，2.1 - 2.6个月），中位生存期为8.9个月（95%CI，6.2 ~ 12.6个月）。结论虽然西妥昔单抗单药治疗重度预治疗的晚期NSCLC患者的缓解率仅为4.5%，在相似的患者组中，疾病控制率和总生存率似乎与培美曲塞、多西他赛和厄洛替尼相当。
PurposeTo determine the efficacy of cetuximab in patients with recurrent or progressive non-small-cell lung cancer (NSCLC) after receiving at least one prior chemotherapy regimen.Patients and MethodsThis was an open-label, phase II study of patients with epidermal growth factor receptor (EGFR) -positive and EGFR-negative advanced NSCLC with Eastern Cooperative Oncology Group performance status 0 to 1. Patients received cetuximab 400 mg/m(2) intravenously (IV) during 120 minutes on week 1 followed by weekly doses of cetuximab 250 mg/m(2) IV during 60 minutes. A cycle was considered as 4 weeks of treatment and therapy was continued until disease progression or intolerable toxicities. The primary end point was to assess response rate. Secondary end points included an estimation of time to progression and survival.ResultsPatient and disease characteristics (n = 66) included EGFR-positive status (n = 60); EGFR-negative status (n = 6); number of prior regimens (one, n = 28; two, n = 27; ! three, n = 11); male (n 41); female (n = 25); adenocarcinoma (n = 36), and smoking status (never, In = 13; former, n 45; current, In = 8). Grade 3/4 toxicities included acne-like rash (6.1 %), anaphylactic reactions (1.5%), and diarrhea (1.5%). The response rate for all patients (n = 66) was 4.5% (95% Cl, 0.9% to 12.7%) and the stable disease rate was 30.3% (95% Cl, 19.6% to 42.9%). The response rate for patients with EGFR-positive tumors (n = 60) was 5% (95% Cl, 1.0% to 13.9%). The median time to progression for all patients was 2.3 months (95% Cl, 2.1 to 2.6 months) and median survival time was 8.9 months (95% Cl, 6.2 to 12.6 months).ConclusionAlthough the response rate with single-agent cetuximab in this heavily pretreated patient population with advanced NSCLC was only 4.5%, the disease control rates and overall survival seem comparable to that of pemetrexed, docetaxel, and erlotinib in similar groups of patients.