Clinical observation of icotinib versus gefitinib in the treatment of EGFR-mutated advanced non-small cell lung cancer

WU Fangyu; CHEN Weidong; XIA Panpan; ZHANG Xudong; SHEN Aizong

doi:10.6039/j.issn.1001-0408.2023.10.14

您当前的位置：

首页 >

文章列表页 >

Clinical observation of icotinib versus gefitinib in the treatment of EGFR-mutated advanced non-small cell lung cancer

更新时间：2025-09-27

- Clinical observation of icotinib versus gefitinib in the treatment of EGFR-mutated advanced non-small cell lung cancer
- ZHONGGUO YAOFANG Vol. 34, Issue 10, Pages: 1228-1232(2023)
- 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：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.10.14
  CLC： R979.1
- Received：28 November 2022，
  
  Revised：2023-03-07，
  
  Accepted：11 April 2023，
  
  Published：30 May 2023
- 稿件说明：
移动端阅览
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[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[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

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

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

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（

＞0.05）；埃克替尼组患者的中位PFS显著优于吉非替尼组（

＝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），

＝0.031

]

和非脑转移患者[HR＝0.58，95%CI（0.36，0.91），

＝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），

＝0.049

]

、EGFR21 exon L858R突变[HR＝0.44，95%CI（0.21，0.89），

＝0.022

]

和埃克替尼治疗[HR＝0.65，95%CI（0.44，0.96），

＝0.030

]

为影响患者预后的因素。

结论

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

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

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

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 （

＞0.05）； median PFS was significantly better in the icotinib group than in the gefitinib group （

＝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），

＝0.031

]

and non-brain metastatic patients [HR＝0.58，95%CI（0.36，0.91），

＝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），

＝0.049

]

， EGFR21 exon L858R mutation [HR＝0.44， 95%CI（0.21，0.89），

＝0.022

]

and icotinib treatment [HR＝0.65， 95%CI （0.44，0.96），

＝0.030

]

were influential factors for prognosis.

CONCLUSIONS

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

Keywords

references

ZHOU C C ， YAO L D . Strategies to improve outcomes of patients with EGRF-mutant non-small cell lung cancer： review of the literature [J ] . J Thorac Oncol ， 2016 ， 11 （ 2 ）： 174 - 186 .

MILLER K D ， NOGUEIRA L ， DEVASIA T ， et al . Cancer treatment and survivorship statistics，2022 [J ] . CA Cancer J Clin ， 2022 ， 72 （ 5 ）： 409 - 436 .

PAO W ， GIRARD N . New driver mutations in non-small-cell lung cancer [J ] . Lancet Oncol ， 2011 ， 12 （ 2 ）： 175 - 180 .

SHOKOOHI A ， AL-HASHAMI Z ， MOORE S ， et al . Effect of targeted therapy and immunotherapy on advanced nonsmall-cell lung cancer outcomes in the real world [J ] . Cancer Med ， 2022 ， 11 （ 1 ）： 86 - 93 .

ZHANG L L ， QI Y ， XING K L ， et al . A novel strategy of EGFR‑TKI combined chemotherapy in the treatment of human lung cancer with EGFR‑sensitive mutation [J ] . Oncol Rep ， 2018 ， 40 （ 2 ）： 1046 - 1054 .

ZHANG L ， MA S L ， SONG X Q ， et al . Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer（INFORM；C-TONG 0804）：a multicentre，double-blind randomised phase 3 trial [J ] . Lancet Oncol ， 2012 ， 13 （ 5 ）： 466 - 475 .

MITSUDOMI T ， MORITA S ， YATABE Y ， et al . Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor（WJTOG3405）：an open label，randomised phase 3 trial [J ] . Lancet Oncol ， 2010 ， 11 （ 2 ）： 121 - 128 .

XIE H N ， WANG H ， XU L ， et al . Gefitinib versus adjuvant chemotherapy in patients with stage Ⅱ-ⅢA non-small-cell lung cancer harboring positive EGFR mutations：a single-center retrospective study [J ] . Clin Lung Cancer ， 2018 ， 19 （ 6 ）： 484 - 492 .

DAI L L ， WANG W ， LI W L ， et al . Effect of gefitinib combined with chemotherapy in patients with advanced NSCLC：a retrospective cohort study [J ] . Int J Gen Med ， 2022 ， 15 ： 637 - 644 .

TAN F L ， SHEN X Y ， WANG D C ， et al . Icotinib（BPI-2009H），a novel EGFR tyrosine kinase inhibitor，displays potent efficacy in preclinical studies [J ] . Lung Cancer ， 2012 ， 76 （ 2 ）： 177 - 182 .

SHI Y K ， ZHANG L ， LIU X Q ， et al . Icotinib versus gefitinib in previously treated advanced non-small-cell lung cancer（ICOGEN）：a randomised，double-blind phase 3 non-inferiority trial [J ] . Lancet Oncol ， 2013 ， 14 （ 10 ）： 953 - 961 .

EISENHAUER E A ， THERASSE P ， BOGAERTS J ， et al . New response evaluation criteria in solid tumours：revised RECIST guideline（version 1.1） [J ] . Eur J Cancer ， 2009 ， 45 （ 2 ）： 228 - 247 .

CHEN AP ， SETSER A ， ANADKAT M J ， et al . Grading dermatologic adverse events of cancer treatments：the Common Terminology Criteria for Adverse Events Version 4.0 [J ] . J Am Acad Dermatol ， 2012 ， 67 （ 5 ）： 1025 - 1039 .

TAN F L ， SHI Y K ， WANG Y X ， et al . Icotinib，a selective EGF receptor tyrosine kinase inhibitor，for the treatment of non-small-cell lung cancer [J ] . Future Oncol ， 2015 ， 11 （ 3 ）： 385 - 397 .

HE J X ， SU C X ， LIANG W H ， et al . Icotinib versus chemotherapy as adjuvant treatment for stage Ⅱ-ⅢA EGFR-mutant non-small-cell lung cancer（EVIDENCE）：a randomised，open-label，phase 3 trial [J ] . Lancet Respir Med ， 2021 ， 9 （ 9 ）： 1021 - 1029 .

中国医疗保健国际交流促进会，广东省胸部疾病学会 . 埃克替尼术后辅助治疗非小细胞肺癌的专家共识 [J ] . 中华肿瘤杂志， 2023 ， 45 （ 1 ）： 31 - 38 .

RANSON M ， HAMMOND L A ， FERRY D ， et al . ZD1839，a selective oral epidermal growth factor receptor tyrosine kinase inhibitor，is well tolerated and active in patients with solid，malignant tumors：results of a phase Ⅰ trial [J ] . J Clin Oncol ， 2002 ， 20 （ 9 ）： 2240 - 2250 .

CHENG Y ， MURAKAMI H ， YANG P C ， et al . Ran-domized phase Ⅱ trial of gefitinib with and without pemetrexed as first-line therapy in patients with advanced nonsquamous non-small-cell lung cancer with activating epidermal growth factor receptor mutations [J ] . J Clin Oncol ， 2016 ， 34 （ 27 ）： 3258 - 3266 .

NORONHA V ， PATIL V M ， JOSHI A ， et al . Gefitinib versus gefitinib plus pemetrexed and carboplatin chemotherapy in EGFR-mutated lung cancer [J ] . J Clin Oncol ， 2020 ， 38 （ 2 ）： 124 - 136 .

HOU X ， LI M C ， WU G W ， et al . Gefitinib plus chemotherapy vs gefitinib alone in untreated EGFR-mutant non-small cell lung cancer in patients with brain metastases：the GAP BRAIN open-label，randomized，multicenter，phase 3 study [J ] . JAMA Netw Open ， 2023 ， 6 （ 2 ）： e2255050 .

SHI Y K ， WANG L ， HAN B H ， et al . First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma（CONVINCE）：a phase 3，open-label，randomized study [J ] . Ann Oncol ， 2017 ， 28 （ 10 ）： 2443 - 2450 .

WU Y L ， CHENG Y ， ZHOU X D ， et al . Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer（ARCHER 1050）：a randomised，open-label，phase 3 trial [J ] . Lancet Oncol ， 2017 ， 18 （ 11 ）： 1454 - 1466 .

WU Y L ， TSUBOI M ， HE J ， et al . Osimertinib in resected EGFR-mutated non-small-cell lung cancer [J ] . N Engl J Med ， 2020 ， 383 （ 18 ）： 1711 - 1723 .

SEQUIST L V ， YANG J C ， YAMAMOTO N ， et al . Phase Ⅲ study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations [J ] . J Clin Oncol ， 2013 ， 31 （ 27 ）： 3327 - 3334 .

Views

273

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Efficacy and safety of ruxolitinib in the treatment of myelofibrosis

Clinical observation of doxycycline in the treatment of macrolide-unresponsive Mycoplasma pneumoniae pneumonia in children under 8 years of age

Meta-analysis of the efficacy and safety of PD-1/PD-L1 inhibitors combined with bevacizumab in the treatment of advanced non-small cell lung cancer

Clinical observation of vonoprazan-based triple therapy in treatment-naive patients with Helicobacter pylori infection

Comparison of the efficacy and safety between the drug winning the bidding for centralized procurement and the original drug of ticagrelor in acute coronary syndrome patients after percutaneous coronary intervention

Related Author

WANG Wanwan

YE Jun

CHENG Hai

YAO Wei

LIU Guiling

ZHENG Jishan

CHEN Yanyan

LI Shanshan

Related Institution

Dept. of Hematology， the Third People’s Hospital of Bengbu

Dept. of Hematology， the Affiliated Hospital of Xuzhou Medical University

Dept. of Pharmacy， Women and Children’s Hospital Affiliated to Ningbo University

Dept. of Paediatrics， Women and Children’s Hospital Affiliated to Ningbo University

Dept. of Pharmacy， the Affiliated Hospital of Zunyi Medical University

⁰