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首页> 外文期刊>Lung cancer: Journal of the International Association for the Study of Lung Cancer >Pooled analysis of the prospective trials of gefitinib monotherapy for EGFR-mutant non-small cell lung cancers.
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Pooled analysis of the prospective trials of gefitinib monotherapy for EGFR-mutant non-small cell lung cancers.

机译：池的前瞻性试验分析吉非替尼单药治疗EGFR-mutant非小细胞肺癌。

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PURPOSE: Epidermal growth factor receptor (EGFR) mutations have been found in the majority of gefitinib-responsive non-small cell lung cancer (NSCLC) patients from retrospective studies. We sought to compile the available phase II and prospective trials of this EGFR tyrosine kinase inhibitor (TKI) to better understand the efficacy and safety of selecting patients to receive gefitinib based on their genotype. DESIGN: We searched published trials involving EGFR-mutant patients and gefitinib. Five reports were identified (published between June 2006 and April 2007) in which gefitinib was given in a prospective manner to EGFR mutation positive patients at a dose of 250mg/day. Responses were determined by RECIST and toxicities by NCI-CTC. RESULTS: A total of 101 patients were pooled from these studies. Fifty-nine received gefitinib as their first line of therapy and 42 after having received chemotherapy. The combined rate of complete and partial response (CR+PR) in the 99 measured patients was 80.8% (80/99)and only 7.1% (7/99) had progressive disease as best response. The response rate (CR+PR) for exon 19 deletion and L858R patients were 80.3% (53/66) and 81.8% (27/33), respectively. The median progression-free survival ranged from 7.7 to 12.9 months. Overall survival had not been reached in 4/5 reports and was 15.4 months in one of them. Gefitinib administration was safe (<50% of patients developed grades 1-2 skin rash or diarrhea) and interstitial lung disease was only reported in two patients (2%), without deaths. CONCLUSIONS: Gefitinib monotherapy leads to objective responses in most patients with EGFR mutations. Both L858R and deletion 19 mutations derived similar clinical benefits. Small molecule TKIs are the new treatment paradigm for EGFR-mutant NSCLC.
机译：目的:表皮生长因子受体(EGFR)突变被发现在大多数gefitinib-responsive非小细胞肺癌(NSCLC)患者的回顾性研究。试图编译可用二期和表皮生长因子受体酪氨酸激酶的前瞻性试验抑制剂(TKI)更好地理解效果和安全的选择病人接受吉非替尼基于他们的基因型。搜索试验涉及EGFR-mutant出版患者和吉非替尼。确定(发表在2006年6月和4月之间吉非替尼是在2007年)潜在的方式EGFR突变阳性病人的剂量250毫克/天。由RECIST NCI-CTC毒性。结果:共有101名患者合并这些研究。第一线治疗和42之后接受化疗。完全和部分响应(CR + PR)在99年测量患者为80.8%(80/99),只有7.1%(7/99)有进步疾病最好的回应。反应率(CR + PR)为外显子19删除和L858R患者80.3%(53/66)和81.8%分别为(27/33)。无进展生存从7.7到12.9不等个月。4/5的报道,其中一个是15.4个月。吉非替尼管理是安全的(< 50%病人等级1 - 2皮疹或开发只是腹泻)和间质性肺疾病在两个病人(2%),没有人死亡。结论:吉非替尼单药治疗导致客观的反应在大多数患者表皮生长因子受体突变。派生的类似临床医学方面的好处。TKIs的新的治疗模式EGFR-mutant非小细胞肺癌。

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