国际医药卫生导报 ›› 2025, Vol. 31 ›› Issue (11): 1905-1910.DOI: 10.3760/cma.j.cn441417-20240704-11027

• 临床研究 • 上一篇    下一篇

EGFR阳性的晚期NSCLC患者应用吉非替尼治疗的效果及安全性

张洋1 王景景1 王博2 李小军2   

  1. 1陕西省核工业二一五医院药学部,咸阳 710068;2陕西省核工业二一五医院胸心外科,咸阳 710068

  • 收稿日期:2024-07-04 出版日期:2025-06-01 发布日期:2025-06-15
  • 通讯作者: 李小军,Email:micho_zhang@126.com
  • 基金资助:

    秦都区科技计划(QK2022sf02);陕西省自然科学基础研究计划(2017JM8163)

Efficacy and safety of gefitinib in the treatment of EGFR-positive advanced NSCLC patients

Zhang Yang1, Wang Jingjing1, Wang Bo2, Li Xiaojun2   

  1. 1 Department of Pharmacy, No.215 Hospital of Shaanxi Nuclear Industry, Xianyang 710068, China; 2 Department of Cardiothoracic Surgery, No.215 Hospital of Shaanxi Nuclear Industry, Xianyang 710068, China

  • Received:2024-07-04 Online:2025-06-01 Published:2025-06-15
  • Contact: Li Xiaojun, Email: micho_zhang@126.com
  • Supported by:

    Science and Technology Plan of Qindu District (QK2022sf02); Basic Research Program of Natural Science of Shaanxi Province (2017JM8163)

摘要:

目的 研究表皮生长因子受体(EGFR)阳性的晚期非小细胞肺癌(NSCLC)患者应用吉非替尼治疗的效果及安全性。方法 选择2019年3月至2021年2月在陕西省核工业二一五医院接受治疗的102例EGFR阳性NSCLC患者进行前瞻性研究,按随机数字表法分为对照组(51例)与研究组(51例)。对照组男30例,女21例;年龄(57.38±5.19)岁;ⅢB期20例,Ⅳ期31例;鳞癌11例,腺癌40例;研究组男28例,女23例;年龄(56.99±5.32)岁;ⅢB期25例,Ⅳ期26例;鳞癌8例,腺癌43例。对照组接受多西他赛治疗,静脉滴注75 mg/m2多西他赛,每3周为1个周期,至少治疗2个周期。研究组接受吉非替尼口服,每次250 mg,每天一次,直至疾病进展或患者无法耐受时停药。采用χ2检验比较两组患者的临床疗效和不良反应,采用t检验比较两组患者治疗前及治疗1个月后EGFR、分泌型蛋白Dikkopf-1(DKK1)、前梯度蛋白2(AGR2)、肿瘤标志物[鳞状上皮细胞癌抗原(SCC)、非小细胞肺癌抗原21-1(CYFRA21-1)、癌胚抗原(CEA)]水平变化,采用Log-rank检验比较两组患者3年生存率。结果 研究组患者疾病控制率为82.35%(42/51),高于对照组的54.90%(28/51),差异有统计学意义(P<0.05)。治疗1个月后,两组患者EGFR、DKK1、AGR2水平均下降,研究组患者EGFR、DKK1、AGR2水平分别为(37.94±4.22)μg/L、(3.59±0.85)μg/L、(8.04±1.68)ng/L,低于对照组的(50.11±5.83)μg/L、(5.04±1.02)μg/L、(12.45±2.59)ng/L,差异均有统计学意义(均P<0.05)。治疗1个月后,两组患者SCC、CYFRA21-1、CEA水平均下降,研究组患者SCC、CYFRA21-1、CEA水平分别为(1.23±0.27)μg/L、(7.76±1.03)μg/L、(46.19±5.83)μg/L,低于对照组的(1.76±0.28)μg/L、(10.24±1.25)μg/L、(53.17±6.84)μg/L,差异均有统计学意义(均P<0.05)。研究组患者的不良反应总发生率为21.57%(11/51),低于对照组的41.18%(21/51),差异有统计学意义(P<0.05)。研究组总生存期为(29.71±3.61)个月,长于对照组的(23.21±3.28)个月,差异有统计学意义(P<0.05)。结论 吉非替尼能够提高EGFR阳性晚期NSCLC患者的疗效,下调EGFR、DKK1、AGR2表达,降低肿瘤标志物水平,且有较高安全性,有利于预后改善。

关键词:  , 非小细胞肺癌, 晚期, 表皮生长因子受体阳性, 吉非替尼, 分泌型蛋白Dikkopf-1, 前梯度蛋白2, 疗效, 安全性, 预后

Abstract:

Objective To study the efficacy and safety of gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) patients with positive epidermal growth factor receptor (EGFR). Methods A prospective study was conducted on 102 patients with EGFR-positive NSCLC who were treated in No.215 Hospital of Shaanxi Nuclear Industry from March 2019 to February 2021, and they were divided into a control group (51 cases) and a study group (51 cases) according to the random number table method. In the control group, there were 30 males and 21 females, aged (57.38±5.19) years, 20 cases in stage ⅢB and 31 cases in stage Ⅳ, 11 cases of squamous cell carcinoma and 40 cases of adenocarcinoma. In the study group, there were 28 males and 23 females, aged (56.99±5.32) years, 25 cases in stage ⅢB and 26 cases in stage Ⅳ, 8 cases of squamous cell carcinoma and 43 cases of adenocarcinoma. The control group received docetaxel treatment, intravenous infusion with 75 mg/m2 of docetaxel, 3 weeks as a cycle, and the treatment lasted for at least 2 cycles. The study group received gefitinib orally, 250 mg each time, once a day, until the disease progressed or the patient could not tolerate it and the drug was discontinued. The χ2 test was used to compare the clinical efficacies and adverse reactions of the two groups. The t-test was used to compare the changes of EGFR, secretory protein Dikkopf-1 (DKK1), pre-gradient protein 2 (AGR2), and tumor markers [squamous cell carcinoma antigen (SCC), non-small cell lung cancer antigen 21-1 (CYFRA21-1), and carcinoembryonic antigen (CEA)] before treatment and one month after treatment in the two groups. The Log-rank test was used to compare the 3-year survival rates of the two groups. Results The disease control rate of the study group was 82.35% (42/51), which was higher than 54.90% (28/51) of the control group, with a statistically significant difference (P<0.05). One month after treatment, the levels of EGFR, DKK1, and AGR2 in both groups decreased; the levels of EGFR, DKK1, and AGR2 in the study group were (37.94±4.22) μg/L, (3.59±0.85) μg/L, and (8.04±1.68) ng/L, which were lower than those in the control group [(50.11±5.83) μg/L, (5.04±1.02) μg/L, and (12.45±2.59) ng/L], with statistically significant differences (all P<0.05). One month after treatment, the levels of SCC, CYFRA21-1, and CEA in both groups decreased; the levels of SCC, CYFRA21-1, and CEA in the study group were (1.23±0.27) μg/L, (7.76±1.03) μg/L, and (46.19±5.83) μg/L, which were lower than those in the control group [(1.76±0.28) μg/L, (10.24±1.25) μg/L, and (53.17±6.84) μg/L], with statistically significant differences (all P<0.05). The total incidence of adverse reactions in the study group was 21.57% (11/51), which was lower than 41.18% (21/51) in the control group, with a statistically significant difference (P<0.05). The overall survival period of the study group was (29.71±3.61) months, which was longer than that of the control group [(23.21±3.28) months], with a statistically significant difference (P<0.05). Conclusion Gefitinib can improve the curative effect of EGFR-positive advanced NSCLC patients, down-regulate the expressions of EGFR, DKK1, and AGR2, reduce the levels of tumor markers, has high safety, and is beneficial to the improvement of prognosis.

Key words: Non-small cell lung cancer,  , Advanced,  , Epidermal growth factor receptor positive,  , Gefitinib,  , Secretory protein Dikkopf-1,  , Pre-gradient protein 2,  , Therapeutic effect,  , Security,  , Prognosis