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医学临床研究  2022, Vol. 39 Issue (7): 1002-1005    DOI: 10.3969/j.issn.1671-7171.2022.07.012
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安罗替尼联合埃克替尼治疗ⅢB/Ⅳ期EGFR基因突变型非小细胞肺癌患者的疗效及安全性
江舟, 陈建华**
中南大学湘雅医学院附属肿瘤医院/湖南省肿瘤医院胸内一科,湖南 长沙 410031
Efficacy and Safety of Arotinib Combined with Ektinib in Patients with Stage ⅢB/ Ⅳ EGFR Gene Mutant Non-small Cell Lung Cancer
JIANG Zhou, CHEN Jian-hua
Department of Thoracic Medicine,Affiliated Cancer Hospital of Xiangya School of Medicine,Central South University,Hunan Cancer Hospital,Changsha Hunan 410031
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摘要 【目的】探讨安罗替尼联合埃克替尼治疗ⅢB/Ⅳ期人表皮生长因子受体(Epidermal Growth Factor Receptor,EGFR)基因突变型非小细胞肺癌(Non-small Cell Lung Cancer,NSCLC)患者的有效性和安全性。【方法】选取2019年3月至2021年3月在本院初治的27例ⅢB/Ⅳ期EGFR基因突变型NSCLC患者,随机分为观察组(采用安罗替尼联合埃克替尼治疗)和对照组(采用埃克替尼治疗),比较两组疗效、无进展生存期(progression free survival,PFS)、总体缓解率(objective response rate,ORR)及疾病控制率(DCR)。【结果】随访截至2022年3月,观察组中位PFS为15.50个月,显著长于对照组的10.00个月,其差异有统计学意义(P<0.05)。根据突变类型不同,分为19外显子缺失L858R点突变组和21外显子缺失L858R点突变组,观察组中19外显子缺失L858R点突变组患者中位PFS为16.00个月,显著高于对照组中19外显子缺失L858R点突变组患者11.75个月,其差异有统计学意义(P<0.05);观察组中21外显子缺失L858R点突变患者中位PFS为14.00个月,与对照组中21外显子缺失L858R点突变患者的8.50个月比较,差异无统计学意义(P>0.05);治疗6周后,观察组ORR、DCR分别为75.00%(9/12)、91.67%(11/12),与对照组的53.33%(8/15)、80.00%(12/15)比较,差异均无统计学意义(P>0.05)。观察组高血压及牙龈出血比例较高,其中2例高血压及转氨酶升高3级,经药物对症处理后均降为1级;对照组皮疹、皮肤瘙痒及甲沟炎发生率稍高于观察组,皮疹、皮肤瘙痒、甲沟炎及转氨酶升高3级,对症处理后均好转,可继续治疗。两组患者毒副反应整体可控。【结论】安罗替尼联合埃克替尼治疗ⅢB/Ⅳ期NSCLC患者,可显著改善患者PFS,且安全性良好。
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江舟
陈建华
关键词 癌, 非小细胞肺/药物疗法基因, erbB-1突变分子靶向治疗治疗结果    
Abstract:【Objective】 To investigate the efficacy and safety of Arotinib combined with Ektinib in the treatment of non-small cell lung cancer (NSCLC) patients with stage ⅢB/Ⅳ human epidermal growth factor receptor (EGFR) gene mutations. 【Methods】A total of 27 patients with stage ⅢB/Ⅳ EGFR mutant NSCLC initially treated in our hospital from March 2019 to March 2021 were randomly divided into the observation group (treated with Arotinib combined with Ektinib) and the control group (treated with Ektinib). The efficacy, progression free survival (PFS), objective response rate (ORR) and disease control rate (DCR) of the two groups were compared. 【Results】Up to March 2022, the median PFS in the observation group was 15.50 months, significantly longer than 10.00 months in the control group, and the difference was statistically significant. According to different mutation types, they were divided into 19 exon deletion L858R point mutation group and 21 exon deletion L858R point mutation group. The median PFS of patients with 19 exon deletion L858R point mutation group in the observation group was 16.00 months, significantly higher than that of patients with 19 exon deletion L858R point mutation group in the control group for 11.75 months, and the difference was statistically significant (P<0.05); The median PFS of patients with exon 21 deletion L858R point mutation in the observation group was 14.00 months, compared with 8.50 months in patients with exon 21 deletion L858R point mutation in the control group, the difference was not statistically significant (P>0.05); After 6 weeks of treatment, the ORR and DCR of the observation group were 75.00% (9/12) and 91.67% (11/12), respectively, compared with 53.33% (8/15) and 80.00% (12/15) of the control group, the difference was not statistically significant (P>0.05). The proportion of hypertension and gingival bleeding in the observation group was higher, in which 2 cases of hypertension and transaminase increased by 3 levels, and all of them decreased to 1 level after symptomatic treatment with drugs; The incidence of skin rash, skin pruritus and paronychia in the control group was slightly higher than that in the observation group. The incidence of skin rash, skin pruritus, paronychia and transaminase increased by 3 levels. After symptomatic treatment, they all improved and can continue to be treated. The toxic and side effects of the two groups of patients were controllable as a whole. 【Conclusion】 Arotinib combined with Ektinib can significantly improve PFS in patients with stage ⅢB/Ⅳ NSCLC, and the safety is good.
Key wordsCarcinoma, Non-Small-Cell Lung/DT    Genes, erbB-1    Mutation    Molecular Targeted Therapy    Treatment Outcome
收稿日期: 2022-06-13     
中图分类号:  R734.2  
基金资助:长沙市科技局自然科学基金资助(编号:kq1901080、kq2202464)
通讯作者: **E-mail: cjh_1000@163.com   
引用本文:   
江舟, 陈建华. 安罗替尼联合埃克替尼治疗ⅢB/Ⅳ期EGFR基因突变型非小细胞肺癌患者的疗效及安全性[J]. 医学临床研究, 2022, 39(7): 1002-1005.
JIANG Zhou, CHEN Jian-hua. Efficacy and Safety of Arotinib Combined with Ektinib in Patients with Stage ⅢB/ Ⅳ EGFR Gene Mutant Non-small Cell Lung Cancer. JOURNAL OF CLINICAL RESEARCH, 2022, 39(7): 1002-1005.
链接本文:  
http://journal07.magtech.org.cn/yxlcyj/CN/10.3969/j.issn.1671-7171.2022.07.012     或     http://journal07.magtech.org.cn/yxlcyj/CN/Y2022/V39/I7/1002
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