盐酸埃克替尼联合阿帕替尼一线治疗表皮生长因子受体21外显子敏感突变的晚期非小细胞肺癌的效果与安全性评价  

Efficacy and safety of icotinib hydrochloride combined with apatinib as the first-line treatment for advanced non-small cell lung cancer patients with epidermal growth factor receptor 21 exon sensitive mutation

作　　者：曹军丽[1] 王欣[2] Cao Junli;Wang Xin(Department of Oncology,First Hospital of Qinhuangdao,Hebei Province,Qinhuangdao 066000,China;Department of Intensive Care Unit,Qinhuangdao Hospital of Traditional Chinese Medicine,Hebei Province,Qinhuangdao 066000,China)

机构地区：[1]河北省秦皇岛市第一医院肿瘤科,066000 [2]河北省秦皇岛市中医医院重症医学科,066000

出　　处：《中国综合临床》2020年第4期319-323,共5页Clinical Medicine of China

基　　金：河北省医学科学研究重点课题计划项目(20171259)。

摘　　要：目的探讨盐酸埃克替尼联合阿帕替尼一线治疗表皮生长因子受体(epidermal growth factor receptor,EGFR)21L858R突变的晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床效果及安全性。方法采用前瞻性研究分析2014年5月至2017年5月秦皇岛市第一医院收治的Ⅳ期EGFR 21L858R突变的NSCLC患者63例的临床资料,其中40例患者仅接受盐酸埃克替尼一线治疗(盐酸埃克替尼组),23例患者接受盐酸埃克替尼联合阿帕替尼一线治疗(盐酸埃克替尼联合阿帕替尼组)。评价两组患者的疗效及不良反应。采用电话或门诊方式随访,末次随访时间为2019年10月1日。结果盐酸埃克替尼组与盐酸埃克替尼联合阿帕替尼组的客观缓解率分别为52.0%(21/40)、73.9%(17/23),疾病控制率分别为92.5%(37/40)、95.7%(22/23),两组间比较差异无统计学意义(P值分别为0.115、1.000)。盐酸埃克替尼组与盐酸埃克替尼联合阿帕替尼组的中位无进展生存时间(progression-free survival,PFS)分别为8.6个月与12.1个月(χ2=22.945,P<0.001)。进一步COX回归分析也显示阿帕替尼联合埃克替尼治疗较单药盐酸埃克替尼可延长患者的PFS(偏回归系数为-1.286,P<0.001)。两组总的不良反应发生率分别为72.5%(29/40)与82.6%(19/23),盐酸埃克替尼组患者无3级以上不良反应,盐酸埃克替尼联合阿帕替尼组患者有1例发生3级不良反应,两组患者总的不良反应和≥3级的不良反应率相比,差异均无统计学意义(P值分别为0.540、0.365)。结论盐酸埃克替尼联合阿帕替尼一线治疗EGFR21L858R突变的NSCLC具有较好的近期效果,可提高患者的无进展生存时间,不良反应可耐受,可作为该类患者一线治疗的一种新选择。Objective To explore the efficacy and safety of icotinib hydrochloride combined with apatinib as the first-line treatment for advanced non-small cell lung cancer(NSCLC)patients with epidermal growth factor receptor(EGFR)21 L858R mutation.Methods A retrospective case-control study was conducted to analyze the clinical data of 63 patients with stage IV EGFR 21L858R mutation who were admitted to Qinhuangdao First Hospital from May 2014 to may 2017.Among them,40 patients only received the first-line treatment of icotinib hydrochloride(icotinib hydrochloride group),23 patients received the first-line treatment of icotinib hydrochloride combined with apatinib(icotinib hydrochloride combined with apatinib group).To evaluate the efficacy and adverse reactions of the two groups.The patients were followed up by telephone or outpatient,and the last follow-up time was October 1,2019.Results The objective response rate of icotinib hydrochloride group and icotinib hydrochloride combined with apatinib group were 52.0%(21/40)and 73.9%(17/23),respectively,the disease control rate were 92.5%(37/40)and 95.7%(22/23),respectively.There was no statistically significant difference between the two groups(P value were 0.115,1.000,respectively).The median progression-free survival(PFS)were 8.6 months vs.12.1 months in icotinib hydrochloride group and icotinib hydrochloride combined with apatinib group(χ2=22.945,P<0.001).Further Cox regression analysis also showed that the PFS of patients treated with apatinib and icotinib hydrochloride was longer than that of patients treated with icotinib hydrochloride alone(partial regression coefficient was-1.286,P<0.001).The total incidence of adverse reactions in the two groups was 72.5%(29/40)and 82.6%(19/23),respectively.There were no grade 3 or above adverse reactions in the icotinib hydrochloride group,and 1 case in the icotinib combined with apatinib group had grade 3 adverse reactions.There was no significant difference between the two groups in the total adverse reactions and the rate of adve

关 键 词：非小细胞肺癌 盐酸埃克替尼 阿帕替尼 一线治疗 表皮生长因子受体突变 

分 类 号：R734.2[医药卫生—肿瘤]