Gefitinib or Chemotherapy for Non-Small-Cell Lung Cancer with Mutated EGFR.
Gefitinib or Chemotherapy for Non-Small-Cell Lung Cancer with Mutated EGFR.
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DOI：
10.1056/nejmoa0909530
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发表时间：
2010-06-24
影响因子：
158.5
通讯作者：
Nukiwa, Toshihiro
中科院分区：
文献类型：
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作者：
Maemondo, Makoto;Inoue, Akira;Nukiwa, Toshihiro
背景：具有表皮生长因子受体(EGFR)敏感突变的非小细胞肺癌对EGFR酪氨酸激酶抑制剂如吉非替尼高度敏感，但其有效性和安全性与标准化疗方案相比知之甚少。方法：我们随机将230名未接受化疗的转移性非小细胞肺癌患者分配到吉非替尼或卡铂紫杉醇治疗。结果：在对前200名患者进行的计划中期数据分析中，吉非替尼组的无进展生存期显著长于标准化疗组(吉非替尼组死亡或疾病进展的风险比，0.36；P
Background: Non-small-cell lung cancer with sensitive mutations of the epidermal growth factor receptor (EGFR) is highly responsive to EGFR tyrosine kinase inhibitors such as gefitinib, but little is known about how its efficacy and safety profile compares with that of standard chemotherapy.Methods: We randomly assigned 230 patients with metastatic, non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy to receive gefitinib or carboplatin-paclitaxel. The primary end point was progression-free survival; secondary end points included overall survival, response rate, and toxic effects.Results: In the planned interim analysis of data for the first 200 patients, progression-free survival was significantly longer in the gefitinib group than in the standard-chemotherapy group (hazard ratio for death or disease progression with gefitinib, 0.36; P