南方医科大学学报

南方医科大学学报 ›› 2015, Vol. 35 ›› Issue (03): 446-.

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吉非替尼与厄洛替尼在EGFR基因敏感突变晚期NSCLC患者一线治疗中的疗效比较

谢亚琳，梁继珍，苏宁   

  • 出版日期:2015-03-20 发布日期:2015-03-20

Gefitinib versus Erlotinib as first-line treatment for patients with advanced EGFR
mutation-positive non-small-cell lung cancer

  • Online:2015-03-20 Published:2015-03-20

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摘要： 目的探讨吉非替尼与厄洛替尼在EGFR基因敏感突变晚期非小细胞肺癌（NSCLC）患者一线治疗中疗效差异。方法按
照入组标准选择既往未接受过治疗的EGFR基因敏感突变晚期NSCLCL患者，随机分为两组：一组接受吉非替尼250 mg/d治
疗，一组接受厄洛替尼150 mg/d治疗，主要观察指标为无进展生存时间（PFS），次要观察指标为总有效率（ORR）和疾病控制率
（DCR）。结果共入组50例患者，其中吉非替尼组27例，厄洛替尼组23例，吉非替尼和厄洛替组的中位PFS分别为8.0个月和
10.0个月，疗效无统计学差异（P=0.293），但厄洛替尼组略显优势。ORR分别为55.6%和60.9%（P=0.711）；DCR分别为85.2%和
87.0%（P=0.861）。无论19号外显子的缺失突变还是21号外显子的L858R错义突变均可以从EGFR-TKI治疗中获益，且突变位
点的不同不能导致EGFR-TKI疗效的差异（P=0.072）。结论吉非替尼和厄洛替尼均是EGFR基因敏感突变晚期NSCLCL患者
有效的一线治疗方案，疗效无统计学差异，但厄洛替尼略显优势。无论19号外显子的缺失突变还是21号外显子的L858R错义
突变均可以从EGFR-TKI治疗中获益。

Abstract: Objective To compare the efficacy of the erlotinib versus gefitinib in the first-line treatment of patients with
advanced EGFR mutation-positive NSCLC. Methods Fifty patients with untreated advanced EGFR mutation- positive NSCLC
were randomly divided into gefitinib group (n=27) and erlotinib group (n=23). The progression-free survival, objective
response rate and disease control rate were evaluated to compare the efficacy of gefitinib and erlotinib. Results There were no
significant differences in the objective response rate (P=0.711) and disease control rate (P=0.861) between the two groups. The
progression-free survival of gefitinib group and erlotinib group was 8.0 months and 10.0 months, respectively. The efficacy of
the two drugs was similar (P=0.293). Conclusion There is no significant differences between gefitinib and erlotinib in the
first-line treatment of patients with advanced EGFR mutation-positive NSCLC.