目的 对比阿法替尼与埃克替尼联合TP化疗治疗晚期表皮生长因子受体(EGFR)突变型非小细胞肺癌(NSCLC)的疗效。方法 选取2018年4月-2021年10月河北北方学院附属第一医院收治78例晚期EGFR突变NSCLC患者,采用随机数字法将所有患者分为对照组和治疗组,每组各39例。两组均给予紫杉醇联合顺铂(TP)化疗方案,对照组口服盐酸埃克替尼片,125 mg/次,3次/d。治疗组餐后3h口服马来酸阿法替尼片,40 mg/次,1次/d。两组均治疗3个月。观察两组患者临床疗效,比较治疗前后两组患者肺癌标志物癌胚抗原(CEA)和细胞角蛋白21-1片段(CYFRA21-1)水平,及循环ctDNA丰度、表皮生长因子受体(EGFR)、人表皮生长因子受体-2(HER-2)水平。结果 治疗组控制率(100.00%)与对照组(92.31%)相比差异无统计学意义。治疗1、3个月后,两组CEA、CYFRA21-1水平明显低于治疗前(P<0.05),同组治疗3个月水平明显低于治疗1个月(P<0.05);且治疗组血清CEA、CYFRA21-1水平明显低于同期对照组(P<0.05)。治疗1、3个月,同组循环ctDNA丰度、EGFR、HER-2水平明显低于治疗前(P<0.05),治疗3个月明显低于治疗1个月(P<0.05),且治疗组循环ctDNA丰度、EGFR、HER-2水平低于同期对照组(P<0.05)。结论 阿法替尼联合TP化疗治疗晚期EGFR突变NSCLC的疗效显著,能进一步降低循环ctDNA丰度、EGFR、HER-2水平,提高治疗效果,安全性高。

Objective To compare the efficacy of alphatinib and ectini combined with TP chemotherapy in adjuvant treatment of advanced epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). Methods Patients (78 cases) with EGFR mutant NSCLC in the First Affiliated Hospital of Hebei North University from April 2018 to October 2021 were divided into control and treatment group according to random number method, and each group had 39 cases. Patients in two groups were treated with TP chemotherapy. Patients in the control group were po administered with Icotinib Hydrochloride Tablets, 125 mg/time, three times daily. Patients in the treatment group po administered with Alfatinib Maleate Tablets 3 h after meals, 40 mg/time, once daily. Patients in two groups were treated for 3 months. After treatment, the clinical evaluation was evaluated, the lung cancer markers CEA and CYFRA21-1 levels, and circulating ctDNA abundance, EGFR, and HER-2 levels in two groups before and after treatment were compared. Results There was no significant difference in the control rate between the treatment group (100.00%) and the control group (92.31%). After 1 and 3 months of treatment, the levels of CEA and CYFRA21-1 in two groups were significantly lower than those before treatment (P＜0.05), the level of treatment for 3 months in the same group was significantly lower than that of treatment for1 month (P＜0.05), and the levels of serum CEA and CYFRA21-1 in the treatment group were significantly lower than those in the control group (P＜0.05). After 1 and 3 months of treatment, the levels of circulating ctDNA, EGFR and HER-2 in the same group were significantly lower than those before treatment (P＜0.05), the level of treatment for 3 months in the same group was significantly lower than that of treatment for1 month (P＜0.05), and the levels of circulating ctDNA, EGFR and HER-2 in the treatment group were lower than those in the control group (P＜0.05). Conclusion Afatinib combined with TP chemotherapy is effective in the treatment of advanced EGFR mutant NSCLC, which can further reduce the abundance of circulating ctDNA, the level of EGFR and HER-2, and improve the therapeutic effect with high safety.

R914

河北省医学科学研究课题(20211359);张家口市市级科技计划项目(2021072D)