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埃克替尼对比吉非替尼治疗EGFR突变型晚期NSCLC的临床观察
Clinical observation of icotinib versus gefitinib in the treatment of EGFR-mutated advanced non-small cell lung cancer
- 中国药房 2023年34卷第10期 页码：1228-1232
- 作者机构：
1.安徽中医药大学药学院，合肥;230012
2.省部共建安徽道地中药材品质提升协同创新中心，合肥 230012
3.中国科学技术大学附属第一医院（安徽省立医院）药剂科，合肥 230001
- 作者简介：
硕士研究生。研究方向：临床药剂学。E-mail：3286947924@qq.com
主任药师，硕士生导师，硕士。研究方向：临床药学、药物经济学。E-mail：shenaizong@ustc.edu.cn
- 基金信息：重大新药创制科技重大专项课题(2020ZX09201-004);安徽省高校协同创新项目
DOI：10.6039/j.issn.1001-0408.2023.10.14
中图分类号： R979.1纸质出版日期：2023-05-30，
收稿日期：2022-11-28，
修回日期：2023-03-07，
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吴方雨,陈卫东,夏盼盼等.埃克替尼对比吉非替尼治疗EGFR突变型晚期NSCLC的临床观察 Δ[J].中国药房,2023,34(10):1228-1232.
WU Fangyu,CHEN Weidong,XIA Panpan,et al.Clinical observation of icotinib versus gefitinib in the treatment of EGFR-mutated advanced non-small cell lung cancer[J].ZHONGGUO YAOFANG,2023,34(10):1228-1232.
吴方雨,陈卫东,夏盼盼等.埃克替尼对比吉非替尼治疗EGFR突变型晚期NSCLC的临床观察 Δ[J].中国药房,2023,34(10):1228-1232. DOI： 10.6039/j.issn.1001-0408.2023.10.14.
WU Fangyu,CHEN Weidong,XIA Panpan,et al.Clinical observation of icotinib versus gefitinib in the treatment of EGFR-mutated advanced non-small cell lung cancer[J].ZHONGGUO YAOFANG,2023,34(10):1228-1232. DOI： 10.6039/j.issn.1001-0408.2023.10.14.
摘要
目的
2
比较埃克替尼与吉非替尼治疗表皮生长因子受体（EGFR）突变型晚期非小细胞肺癌（NSCLC）的疗效和安全性。
方法
2
回顾性分析2015年12月－2021年9月我院就诊的EGFR突变型晚期NSCLC患者资料146例，按用药的不同分为埃克替尼组（73例）和吉非替尼组（73例）。埃克替尼组患者单用盐酸埃克替尼片（125 mg，每日3次，口服）或联合常规化疗；吉非替尼组患者单用吉非替尼片（0.25 g，每日1次，口服）或联合常规化疗。观察两组患者的近期临床疗效、无进展生存期（PFS），采用Cox回归模型分析影响患者预后的因素，记录两组患者的不良反应发生情况。
结果
2
两组患者的客观缓解率，疾病控制率，1～2级、3～4级不良反应总发生率比较，差异均无统计学意义（
P
＞0.05）；埃克替尼组患者的中位PFS显著优于吉非替尼组（
P
＝0.048）。基于患者基本资料的PFS亚组分析结果显示，与吉非替尼组比较，埃克替尼组中女性[HR＝0.57，95%CI（0.34，0.96），
P
＝0.031]和非脑转移患者[HR＝0.58，95%CI（0.36，0.91），
P
＝0.017]的PFS显著延长。回归模型分析结果显示，EGFR19 exon Del突变[HR＝0.50，95%CI（0.25，1.00），
P
＝0.049]、EGFR21 exon L858R突变[HR＝0.44，95%CI（0.21，0.89），
P
＝0.022]和埃克替尼治疗[HR＝0.65，95%CI（0.44，0.96），
P
＝0.030]为影响患者预后的因素。
结论
2
埃克替尼与吉非替尼治疗EGFR突变型晚期NSCLC的近期临床疗效和安全性均相当，但埃克替尼可以显著延长患者的PFS；EGFR19 exon Del和EGFR21 exon L858R突变及接受埃克替尼治疗是影响患者预后的因素。
Abstract
OBJECTIVE
2
To compare the efficacy and safety of icotinib and gefitinib in the treatment of epidermal growth factor receptor （EGFR）-mutated advanced non-small cell lung cancer （NSCLC）.
METHODS
2
The data of 146 patients with EGFR-mutant advanced NSCLC of our Hospital from December 2015 to September 2021 were retrospectively analyzed and divided into the gefitinib group （73 cases） and the icotinib group （73 cases） according to the drug use. Patients in the gefitinib group were given 0.25 g of gefitinib tablets once a day orally by single drug or combined with conventional chemotherapy， while patients in the icotinib group were given 125 mg of icotinib hydrochloride tablets three times a day orally by single drug or combined with conventional chemotherapy. Short-term efficacy， progression-free survival （PFS） were observed； Cox regression model was used to analyze the factors affecting the prognosis of patients； the occurrence of ADR were observed in the two groups.
RESULTS
2
There was no statistically significant difference in the objective remission rate， disease control rate， and the incidence of grade 1-2 and grade 3-4 adverse drug reactions between the two groups （
P
＞0.05）； median PFS was significantly better in the icotinib group than in the gefitinib group （
P
＝0.048）. Results of subgroup analysis based on patients basic information showed that compared with the gefitinib group， PFS of female [HR＝0.57，95%CI（0.34，0.96），
P
＝0.031] and non-brain metastatic patients [HR＝0.58，95%CI（0.36，0.91），
P
＝0.017] in icotinib group were prolonged significantly. Results of regression model analysis showed that EGFR19 exon Del mutation [HR＝0.50， 95%CI（0.25，1.00），
P
＝0.049]， EGFR21 exon L858R mutation [HR＝0.44， 95%CI（0.21，0.89），
P
＝0.022] and icotinib treatment [HR＝0.65， 95%CI （0.44，0.96），
P
＝0.030] were influential factors for prognosis.
CONCLUSIONS
2
The short-term efficacy and safety of icotinib and gefitinib in the treatment of EGFR-mutant advanced NSCLC are comparable， but icotinib can significantly prolong the patients’ PFS； EGFR19 exon Del， EGFR21 exon L858R mutations and icotinib treatment are factors affecting patients’ prognosis.
关键词
吉非替尼埃克替尼表皮生长因子受体突变晚期非小细胞肺癌疗效安全性
Keywords
icotinibEGFR mutationadvanced non-small cell lung cancerefficacysafety
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