首页|安罗替尼联合吉非替尼一线治疗EGFR阳性的晚期非小细胞肺癌的临床效果分析

安罗替尼联合吉非替尼一线治疗EGFR阳性的晚期非小细胞肺癌的临床效果分析

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目的:探索抗血管生成药物安罗替尼联合吉非替尼一线用于治疗晚期EGFR敏感突变的非小细胞肺癌患者的临床效果和安全性.方法:选取 2019 年 5 月—2021 年 2 月于连云港市第一人民医院肿瘤内科就诊并确诊的晚期非小细胞肺癌(NSCLC)患者21 例,纳入患者既往未经治疗、EGFR突变阳性(外显子19缺失或21L858R),均给予安罗替尼和吉非替尼治疗,直至疾病进展或治疗出现不可耐受的毒副反应为止.主要终点为无进展生存期(PFS),次要终点是客观缓解率(ORR)、疾病控制率(DCR)、总生存期(OS)和安全性.结果:首次随访至2021年3月,结果显示联合治疗中部分缓解(PR)13例,ORR 61.90%,疾病进展(PD)7例,失访1例,中位PFS值为15.7个月[95%CI(9.4,22.1)].继续随访至 2022 年 9 月,PR 10 例,疾病稳定(SD)2 例,ORR为 47.62%,DCR为 57.14%,PD 4 例,失访及死亡 5 例,中位PFS值为 27.1 个月[95%CI(22.9,31.2)],2 年OS率为 66.70%,未达到中位OS,患者整体生存率较高.Cox多因素回归分析结果显示,KPS评分[HR=0.696,95%CI(0.537,0.902),P=0.006]是预测联合方案一线治疗EGFR阳性的晚期NSCLC预后的独立影响因素.常见不良反应(TRAEs)为皮疹(47.62%)、高血压(33.33%)、高血脂(19.05%)及手足皮肤反应(19.05%),其次为蛋白尿、腹泻等.结论:安罗替尼联合吉非替尼对EGFR突变阳性的晚期NSCLC患者具有良好的疗效,且安全性可控.
The Clinical Efficacy Analysis of Combining Anlotinib with Gefitinib as A First-line Treatment for EGFR-positive Advanced Non-small Cell Lung Cancer
Objective:To explore the clinical efficacy and safety of the combination of the anti-angiogenic agent Anlotinib and Gefitinib as first-line treatment for advanced non-small cell lung cancer(NSCLC)patients with epidermal growth factor receptor(EGFR)-sensitive mutations.Method:A total of 21 patients with advanced NSCLC who were diagnosed and treated at the Department of Oncology,the First People's Hospital of Lianyungang from May 2019 to February 2021 were included in this study,the patients had not received prior treatment,and were EGFR mutation-positive(exon 19 deletion or 21L858R).They were treated with Anlotinib and Gefitinib,until disease progression or intolerable toxic side effects occurred.The primary endpoint was progression-free survival(PFS),and the secondary endpoints were objective response rate(ORR),disease control rate(DCR),overall survival(OS),and safety.Result:The first follow-up was conducted until March 2021.The results showed that among the patients receiving the combination treatment,there were 13 cases of partial remission(PR),with an ORR of 61.9%,7 cases of progressive disease(PD),and 1 case lost to follow-up.The median PFS was 15.7 months[95%CI(9.4,22.1)].Follow-up continued until September 2022,with 10 cases of PR,2 cases of stable disease(SD),an ORR of 47.62%,a DCR of 57.14%,4 cases of PD,5 cases lost to follow-up or death,and a median PFS of 27.1 months[95%CI(22.9,31.2)].The 2-year OS rate was 66.70%,and the median OS was not reached,indicating a relatively high overall survival rate among the patients.Cox multivariate regression analysis showed that KPS score[HR=0.696,95%CI(0.537,0.902),P=0.006]was an independent prognostic factor for the first-line treatment of EGFR-positive advanced NSCLC using this combination therapy.The most common treatment-related adverse events(TRAEs)were rash(47.62%),hypertension(33.33%),hyperlipidemia(19.05%),and hand-foot skin reaction(19.05%),proteinuria,diarrhea,and other adverse events.Conclusion:The combination of Anlotinib and Gefitinib has demonstrated good efficacy and controllable safety in patients with advanced NSCLC with EGFR mutations.

Advanced non-small cell lung cancerGefitinibAnlotinibEpidermal growth factor receptorTyrosine kinase inhibitors

刘玮萱、王鑫、娄智、吉亚君

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锦州医科大学研究生培养基地连云港市第一人民医院肿瘤内科 江苏 连云港 222000

连云港市第一人民医院肿瘤内科 江苏 连云港 222000

非小细胞肺癌 吉非替尼 安罗替尼 表皮生长因子受体 酪氨酸激酶抑制剂

北京医卫健康公益基金会医学科学研究项目

13185016

2024

中国医学创新
中国保健协会

中国医学创新

影响因子:1.706
ISSN:1674-4985
年,卷(期):2024.21(13)
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