EGFR21突变晚期NSCLC埃克替尼单药/联合化疗与EGFR19突变患者疗效对比的回顾性研究
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南京医科大学第一附属医院肿瘤科

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国家自然科学基金项目(面上项目,重点项目,重大项目)


Comparison of clinical outcomes of NSCLC patients harbouring EGFR exon 21 or exon 19 mutation after Icotinib versus Icotinib combined with chemotherapy:a retrospective study
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Department of Oncology,the First Affiliated Hospital of Nanjing Medical University

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the National Natural Science Foundation of China

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    摘要:

    目的:观察表皮生长因子受体(epidermal growth factor receptor,EGFR)21外显子突变的晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者在接受埃克替尼单药或联合含铂双药化疗一线治疗中与EFGR19外显子突变患者的疗效差异。方法:回顾性分析2012年8月-2020年10月江苏省人民医院收治的174例EGFR突变阳性初治晚期NSCLC患者,其中EGFR 21外显子突变82例,38例接受埃克替尼单药治疗,44例接受埃克替尼联合含铂双药治疗;EGFR 19外显子突变92例,43例接受埃克替尼单药治疗,49例接受埃克替尼联合含铂双药化疗。分别比较EGFR21及19突变患者在两组治疗方案中的客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、无进展生存期(progression-free survival,PFS)、总生存期(overall survival,OS)的差异。结果:接受埃克替尼单药治疗的患者中,EGFR21外显子突变患者的中位PFS较EGFR19外显子突变患者减少3.5个月(中位PFS:9.5个月vs. 13.0个月,P=0.046),中位OS、治疗1周期后ORR、DCR无显著差异(P>0.05)。接受埃克替尼联合含铂双药化疗的患者中,EGFR21外显子突变患者较19外显子突变患者PFS、OS、治疗1周期后ORR、DCR无显著差异(P>0.05)。EGFR21外显子突变患者中,联合组中位PFS较单药组延长5.8个月(中位PFS:15.3个月vs. 9.5个月,P=0.002),中位OS较单药组延长20.2个月(中位OS:46.0个月vs. 25.8个月,P=0.004)。两组患者治疗一周期后ORR、DCR无显著差异(P>0.05)。EGFR19外显子突变患者中,联合组中位PFS较单药组延长9.1个月(中位PFS:22.1个月vs. 13.0个月,P<0.001)),中位OS较单药组延长35个月(中位OS:61.0个月vs. 26.0个月,P<0.001))。两组患者治疗一周期后ORR、DCR无显著差异(P>0.05)。结论:对于EGFR敏感突变的晚期NSCLC患者,埃克替尼联合化疗一线治疗对比埃克替尼单药治疗,可显著改善PFS及OS,尤其应用于21外显子突变患者中可取得与19外显子突变患者相当的PFS及OS。

    Abstract:

    Objective: This study compared prognoses of advanced non-small cell lung cancer patients with epidermal growth factor receptor exon 19 or 21 mutations after two types of first-line treatment: Icotinib hydrochloride alone or Icotinib combined with chemotherapy. Methods: The clinical data of 174 patients admitted to Jiangsu Provincial People's Hospital from August 2012 to October 2020 were retrospectively analyzed. Totally, 82 cases carried EGFR 21 exon mutation, 38 cases received first-line Icotinib therapy, while 44 cases received Icotinib combined with the chemotherapy. 92 cases were with the presence of EGFR19 exon mutation,43 cases received first-line Icotinib therapy, and 49 cases received Icotinib combined with chemotherapy. We compared differences in objective response rate, disease control rate, progression-free survival, and overall survival between EGFR 21 and 19 exon mutation patients after receiving different treatment regimens. Results:Among the patients receiving Icotinib treatment, the patients with EGFR21 mutation had a median PFS that was 3.5 months shorter than those with 19 mutation (median PFS: 9.5 months vs. 13.0 months, P=0.046). There were no significant differences in the median OS, ORR and DCR after 1 cycle of treatment (P>0.05). Among patients receiving Icotinib combined with chemotherapy, there was no significant difference in PFS, OS, ORR and DCR after 1 cycle of treatment in patients with EGFR exon 21 mutation compared to patients with EGFR exon 19 mutation (P>0.05). Among patients with EGFR 21 exon mutations, the median PFS was 5.8 months longer in the combination group compared to the single-agent group (median PFS:15.3 months vs. 9.5 months, P=0.002) and the median OS was 20.2 months longer than in the single-agent group (median OS: 46.0 months vs. 25.8 months, P=0.004). There was no significant difference in ORR or DCR between the two groups after one cycle of treatment (P>0.05). Among patients with EGFR 19 exon mutations, median PFS was 9.1 months longer in the combination group compared to the single-agent group (median PFS:22.1 months vs. 13.0 months, P<0.001)) and median OS was 35 months longer in the combination group compared to the single-agent group (median OS: 61.0 months vs. 26.0 months, P<0.001)). There was no significant difference in ORR and DCR between the two groups after one cycle of treatment (P>0.05). Conclusion:For patients with advanced NSCLC with EGFR-sensitive mutations, first-line treatment with Icotinib combined with chemotherapy significantly improved PFS and OS compared with Icotinib monotherapy. In particular, the PFS and OS in patients with EGFR 21 exon mutations were comparable to those in patients with EGFR 19 exon mutations.

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  • 收稿日期:2021-04-15
  • 最后修改日期:2021-05-18
  • 录用日期:2021-09-01
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