Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations
Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations
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DOI：
10.1016/j.lungcan.2008.09.010
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发表时间：
2009-06-01
期刊：
影响因子：
5.3
通讯作者：
Yasumoto, Kosei
中科院分区：
文献类型：
--
作者：
Sugio, Kenji;Uramoto, Hidetaka;Yasumoto, Kosei
背景资料：本研究前瞻性地评估了吉非替尼的疗效和对表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者的生存获益。方法：接受手术后复发性疾病或晚期NSCLC疾病（IIIB或IV），其中表现出EGFR突变的患者有资格参加本研究。检查外显子19-21中的EGFR突变。结果：48例非小细胞肺癌患者中20例检测到EGFR突变，19例患者入组并接受吉非替尼治疗。7例患者有19号外显子缺失，10例有L 858 R，我两者都有，1例有19号外显子缺失和G796 A。总有效率为63.2%，疾病控制率为89.5%。在外显子19缺失和L 858 R的患者中，缓解率分别为71.4%和60.0%。中位无进展生存期为7.1个月，中位生存期为20.0个月。未观察到危及生命的毒性。5例获得性耐药肿瘤中有4例出现获得性T790 M突变。结论：EGFR基因19或21号外显子突变是吉非替尼疗效的良好预测指标。(C)2008爱思唯尔爱尔兰有限公司保留所有权利。
Background: This study prospectively assessed the efficacy of gefitinib and the survival benefit for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations.Method: Patients with either recurrent disease after undergoing surgery or advanced NSCLC disease (IIIB or IV) which demonstrated EGFR mutations were eligible for this study. EGFR mutations in exons 19-21 were examined. The patients with EGFR mutations were enrolled in this study after obtaining their informed consent a second time, and they were thereafter treated with gefitinib.Results: EGFR mutations were detected in 20 of 48 patients with NSCLC, and 19 patients were enrolled onto this study and treated with gefitinib. Seven patients had an exon 19 deletion, 10 had L858R, I had both, and 1 had an exon 19 deletion and G796A. The overall response Fate was 63.2%, and the disease control rate was 89.5%. In patients with an exon 19 del and L858R, the response rates were 71.4% and 60.0%, respectively. The median progression-free survival time was 7.1 months, and the median survival time was 20.0 months. No life-threatening toxicity was observed. Four of five acquired resistant tumors showed an acquired T790M mutation.Conclusions: EGFR mutations in exons 19 or 21 are considered to be a good predictor of the efficacy of gefitinib. (C) 2008 Elsevier Ireland Ltd. All rights reserved.