目的回顾性分析EGFR-TKI治疗化疗失败后的Ⅳ期非小细胞肺癌的临床资料,探讨影响EGFRTKI疗效和预后的相关因素。方法收集福建省肿瘤医院2012年1月~2015年1月诊治的88例经病理学或细胞学证实的化疗失败后的Ⅳ期非小细胞肺癌口服EGFR-TKI治疗的临床资料,观察临床特征、治疗效果及生存时间。应用SPSS20.0软件进行统计学分析。结果全组患者88例,客观缓解率(ORR)为52.3%(46/88),疾病控制率(DCR)90.9%(80/88)。ECOG评分0,1分的ORR高于ECOG评分≥2者,83.3%vs30.8%,P=0.00;有吸烟史的ORR率低于无吸烟史,33.3%vs 60.7%,P=0.011;而年龄、性别、病理类型、敏感突变或突变状态未知、EGFR-TKI治疗时机等不影响EGFR-TKI近期疗效。全组患者中位无进展生存期为10.0个月,(95%CI 8.56~11.43)个月,中位总生存期为25个月(95%CI:19.64~30.36)个月。EGFR突变的患者42例(19del 24例,21 L858R 18例)中,EGFR19del突变的PFS优于L858R突变(12.0个月vs 8.0个月,P=0.010)。单因素分析显示,ECOG评分、吸烟史影响PFS及OS。ECOG评分0,1分的PFS、OS长于ECOG评分≥2分者(分别为12.0个月vs 6.0个月,P=0.000;40.0个月vs 19.0个月,P=0.000),无吸烟史的PFS、OS长于有吸烟史组(分别为10.0个月vs 6.0个月,P=0.007;30.0个月vs18.0个月,P=0.004)。多因素分析显示:ECOG评分是影响PFS及OS的独立影响因素。结论 (1)对于EGFR敏感突变或突变优势的Ⅳ期NSCLC患者,二线及二线以上使用EGFR-TKI可获益,疗效与一线EGFR-TKI治疗相近;(2)ECOG评分是影响PFS及OS的独立影响因素,ECOG评分0,1分的患者及未吸烟的患者有较好的ORR率,二线与二线以上EGFR-TKI疗效无明显差别;(3)EGFR 19del组与L858R组相比,近期有效率及OS无明显差别,但19del组PFS更长。 Objective To retrospectively analyze the clinical data of non-small cell lung cancer (NSCLC) after the failure of chemotherapy with EGFR-TKI and to explore the related factors that affect the efficacy and prognosis of EGFRTKI. Methods The clinical data of 88 oral EGFR-TKI patients with stage Ⅳ non-small cell lung cancer after pathological or cytological confirmation of Fujian Cancer Hospital from January 2012 to January 2015 were collected. The clinical features, Therapeutic effect and survival time. Application SPSS20.0 software for statistical analysis. Results All the patients had 88 cases. The objective response rate (ORR) was 52.3% (46/88) and the rate of disease control (DCR) was 90.9% (80/88). The ORR of ECOG scores 0 and 1 was higher than that of ECOG scores ≥ 2, 83.3% vs 30.8%, P = 0.00; ORR of smoking history was lower than that of non-smoking history, 33.3% vs 60.7%, P = 0.011; Age, sex, pathological type, sensitive mutation or mutation status are unknown, and the timing of EGFR-TKI treatment does not affect the short-term effect of EGFR-TKI. The median progression-free survival was 10.0 months in all patients (95% CI 8.56 to 11.43), with a median overall survival of 25 months (95% CI 19.64-30.36) months. In 42 patients with EGFR mutation (24 cases in 19del and 18 cases in 21 L858R), PFS of EGFR19del mutation was superior to L858R mutation (12.0 months vs 8.0 months, P = 0.010). Univariate analysis showed that ECOG score and smoking history influenced PFS and OS. The PFS with ECOG score of 0 and 1 was longer than those with ECOG score of ≥ 2 (P = 0.000 for 12.0 months vs 6.0 months, P = 0.000 for 40.0 months vs 19.0 months, PFS = 0.000) , OS longer than those with smoking history (10.0 months vs 6.0 months, respectively, P = 0.007; 30.0 months vs. 18.0 months, P = 0.004). Multivariate analysis showed that ECOG score was an independent influencing factor for PFS and OS. Conclusions (1) EGFR-TKI on the second-line and the second-line can benefit EGFR-TKI therapy in patients with stage IV NSCLC sensitive to mutation or mutation of EGFR. (2) ECOG score is independent of PFS and OS There was a good ORR rate in the patients with ECOG score of 0 and 1, and non-smoking patients. There was no significant difference in the efficacy of EGFR-TKI between second-line and second-line. (3) Compared with L858R group, And OS no significant difference, but 19del group PFS longer.