目的：探讨吸烟对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）患者治疗中疗效及安全性。方法选择EGFR基因敏感突变晚期NSCLC患者，随机分为吸烟和非吸烟两组：每一组分别接受吉非替尼和厄洛替尼治疗。结果吸烟者和非吸烟者中位PFS分别为12个月和18个月，疗效有统计学差异（P=0.293）；吸烟者吉非替尼和厄洛替组的中位PFS分别为10.0个月和11个月，疗效无统计学差异（P=0.276）。ORR(总有效率)分别为53.3%和66.6%（P=0.266）；DCR（疾病控制率）分别为80.0%和83.3%（P=0.861）。非吸烟者吉非替尼和厄洛替组的中位PFS分别为17个月和19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76.9%和80.0%（P=0.711）；DCR分别为92.3%和90.0%（P=0.751）。结论无论吸烟非吸烟均可以从EGFR-TKI治疗中获益，且不吸烟者能导致疗效有统计学差异。%ABSTRACT:Objective To investigate effect and safety comparison of smoking for gefitinib and erlotinib in EGFR gene mutation in treatment of patients with advanced NSCLC. Method choose patients with advanced NSCLC of EGFR sensitive gene mutations, and divide them randomly into two groups of smoking and non-smoking:each group was treated with gefitinib and erlotinib respectively. Result median PFS of smokers and non-smokers was respectively 12 and 18 months, curative effect is statistically difference (P=0.293);median PFS of smokers by gefitinib and erlotinib was 10 and 11 months, and curative effect shows no statistical difference (P=0.276). ORR (overall remission rate) was 53.3%and 66.6%(P=0.266);DCR (disease control rate) was 80%and 83.3%(P=0.861) respectively. Median PFS of non-smokers for gefitinib and erlotinib was 17 and 19 months,curative effect shows no significant difference (P=0.293), but erlotinib group has slight advantage. ORR was 76.9%and 80%respectively(P=0.711);DCR was 92.3%and 90%(P=0.751) respectively. Conclusion both smokers and non-smokers can benefit from EGFR-TKI treatment, and non-smokers can cause significant differences in curative effect.
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