吉非替尼一线与二线治疗EGFR突变型晚期非小细胞肺癌的疗效比较

Comparison of therapeutic efficacy of gefitinib as first-and second-line therapies for patients with EGFR mutated advanced non-small cell lung cancer

目的:观察吉非替尼用于表皮生长因子受体(epidermal growth factor receptor,EGFR)突变型晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)一线或二线治疗对患者近期疗效及生存期的影响,分析吉非替尼的最佳治疗时机。方法:回顾性分析61例EGFR突变型(外显子19或21突变)晚期NSCLC患者的病历和随访资料,其中31例患者接受吉非替尼一线治疗,30例患者接受吉非替尼二线治疗;应用Kaplan-meier法进行生存分析。结果:两组患者的性别(P=0.717)、年龄(P=0.849)、吸烟史(P=0.173)、病理类型(P=0.573)和临床分期(P=0.668)的差异无统计学意义。吉非替尼一线较二线治疗EGFR突变型NSCLC的近期有效率及疾病控制率明显提高(RR:64.5%vs 23.3%,P=0.001;DCR:87.1%vs 60.0%,P=0.016)。吉非替尼一线和二线治疗的中位无进展生存期分别为7.6和6.4个月(P=0.392),中位总生存期分别为16.0和17.6个月(P=0.606)。另外,在最终获得疾病控制的患者中,吉非替尼一线治疗组为27例,二线治疗组为18例,2组中位无进展生存期及总生存期也无明显差异(PFS:8.0 vs 9.7个月,P=0.777;OS:17.0 vs 20.0个月,P=0.196)。结论:吉非替尼用于EGFR突变型晚期NSCLC患者,一线较二线治疗的近期疗效明显提高,但生存获益无明显差异。

Objective: To evaluate the efficacy and survival of gefitinib as first- line therapy and second- line therapy in advanced EGFR mutated NSCLC and analyze the best timing of gefitinib treatment. Methods:Medical records and follow- up information of 61 patients with EGFR mutated(Exon19 or 21) advanced NSCLC were retrospectively reviewed. Thirty- one patients were treated with gefitinib as first- line therapy,and 30 were treated with gefitinib as second- line therapy. Survival analysis was evaluated by using Kaplan- meier method. Results:The two groups were comparable in gender( P = 0. 717),age( P = 0. 849),smoking history( P = 0. 173),pathology( P= 0. 573) and clinical stage(P = 0. 668). The response rates and disease control rates in the first- line therapy was significantly higher than the second- line therapy(RR:64. 5% vs 23. 3%,P = 0. 001;DCR:87. 1% vs 60. 0%,P =0. 016). The median progression- free survival in the two groups were 7. 6 and 6. 4 months,respectively( P =0. 392). The median overall survivals in the two groups were 16. 0 and 17. 6 months( P = 0. 606). The median progression- free survival and median overall survival of patients with disease control in the first- line therapy group was similar to that of the second- line therapy group(PFS:8. 0 vs 9. 7 months,P = 0. 777;OS:17. 0 vs 20. 0 months,P =0. 196). Conclusion:To EGFR mutated advanced NSCLC the efficacy of gefitinib treatments was significantly higher in first- line therapy than in second- line therapy,however the survival was similar between two groups.