阿帕替尼联合二线化疗用于驱动基因阴性晚期非小细胞肺癌患者的临床研究  

Clinical trial of apatinib combined with second-line chemotherapy in the treatment of patients with driver gene-negative advanced non-small cell lung cancer

作　　者：李一帆[1] 黄灿[3] 马宜明[1] 江洁美[1] 韦炜[2] LI Yi-fan;HUANG Can;MA Yi-ming;JIANG Jie-mei;WEI Wei(Department of Pharmacy,First Affiliated Hospital of Anhui Medical University,Hefei 230001,Anhui Province,China;Department of Oncology,First Affiliated Hospital of Anhui Medical University,Hefei 230001,Anhui Province,China;Department of Pharmacy,Anqing Municipal Hospital,Anqing 246000,Anhui Provine,China)

机构地区：[1]安徽医科大学第一附属医院药剂科,安徽合肥230001 [2]安徽医科大学第一附属医院肿瘤内科,安徽合肥230001 [3]安庆市立医院药剂科,安徽安庆246000

出　　处：《中国临床药理学杂志》2023年第15期2154-2158,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的研究阿帕替尼片联合二线化疗对驱动基因阴性晚期非小细胞肺癌的疗效及生存分析。方法将驱动基因阴性晚期非小细胞肺癌患者分为试验组和对照组。对照组采用二线药物化疗(第1天,75 mg·m^(-2)多西他赛,静脉滴注1 h,或卡瑞利珠单抗,每次200 mg或吉西他滨1000 mg·m^(-2),21 d为1个周期);试验组在对照组治疗的基础上,另给予阿帕替尼(500 mg,早餐后口服,21 d为1个周期)。比较2组患者的卡氏评分、近期疗效、血清细胞角蛋白19片段抗原(CYFRA21-1)、鳞状上皮细胞癌相关抗原(SCC)水平、免疫功能及药物不良反应,并用Kaplan-Meier分析患者生存情况。结果试验组和对照组各42例。治疗后,试验组和对照组的卡氏评分分别为(65.08±10.24)和(57.75±9.53)分;客观缓解率(ORR)分别为47.62%和26.19%,血清CYFRA21-1分别为(5.18±0.92)和(8.49±1.68)μg·L^(-1),血清SCC水平分别为(1.44±0.28)和(2.02±0.43)μg·L^(-1),CD4^(+)分别为(40.97±7.83)%和(36.51±6.14)%,CD4^(+)/CD8^(+)分别为1.86±0.37和1.57±0.25,NK细胞分别为(42.71±7.87)%和(38.92±6.84)%,差异均有统计学意义(均P<0.05)。2组患者的药物不良反应发生率差异无统计学意义(P>0.05)。试验组和对照组的中位无进展生存时间分别为8.14和5.06个月,差异有统计学意义(P<0.05)。结论阿帕替尼片联合二线化疗用于驱动基因阴性晚期非小细胞肺癌患者疗效确切,同时能够降低肿瘤标志物水平,改善免疫功能,延长患者生存时间。Objective To investigate the efficacy and survival analysis of apatinib tablets combined with second-line chemotherapy in driver gene-negative advanced non-small cell lung cancer.Methods Patients with driver gene-negative advanced non-small cell lung cancer were divided into treatment group and control group.The control group received second-line chemotherapy(on the first day,75 mg·m^(-2) docetaxel,intravenous drip for 1 hour,or carbirizumab 200 mg or gemcitabine 1000 mg·m^(-2),21 d as one cycle),and the treatment group was given apatinib(500 mg,taken orally after breakfast,21 d per cycle)on the basis of the control group.The Kaplan score,short-term efficacy,serum cytokeratin 19 fragment antigen(CYFRA21-1),squamous cell carcinoma-associated antigen(SCC)levels,immune function and adverse drug reactions were compared between the two groups,and Kaplan-Meier was used to analyze the survival of the patients’condition.Results There were 42 cases in treatment group and 42 cases in control group.After treatment,the Karnofsky scores in treatment group and control group were 65.08±10.24 and 57.75±9.53;the objective response rate(ORR)were 47.62%,26.19%;the levels of serum CYFRA21-1 were(5.18±0.92),(8.49±1.68)μg·L^(-1);SCC were(1.44±0.28),(2.02±0.43)μg·L^(-1);CD4^(+)were(40.97±7.83)%,(36.51±6.14)%;CD4^(+)/CD8^(+)were 1.86±0.37,1.57±0.25;NK cells were(42.71±7.87)%,(38.92±6.84)%,the difference were statistically significant(all P<0.05).There was no statistical difference in the incidence of adverse drug reactions in both groups(P>0.05).The median progression-free survival time in treatment group and control group were 8.14 months and 5.06 months,the difference was statistically significant(P<0.05).Conclusion Apatinib tablets combined with second-line chemotherapy is effective in driver gene-negative advanced non-small cell lung cancer patients,and can reduce tumor marker levels,improve immune function,and prolong patient survival.

关 键 词：阿帕替尼片 二线化疗 驱动基因阴性 晚期非小细胞肺癌 

分 类 号：R979.1[医药卫生—药品]