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EGFR-TKIs联合中药与单纯EGFR-TKIs治疗晚期非小细胞肺癌的队列研究

Cohort Study of EGFR-TKIs Combined with Traditional Chinese Medicine and Single EGFR-TKIs for Advanced NSCLC (Non-small Cell Lung Cancer)

  • 摘要: 目的 分析表皮生长因子受体酪氨酸激酶抑制剂(epidermal growth factor receptor-tyrosine kinase inhibitors,EGFR-TKIs)联合中药与单纯EGFR-TKIs一线治疗晚期非小细胞肺癌的疗效。 方法 采用队列研究,59例EGFR基因突变的晚期非小细胞肺癌患者,按2:1比例分配至试验组(39例)和对照组(20例)。试验组采用EGFR-TKIs联合中药口服,对照组单用EGFR-TKIs。分析两组无进展生存期(progression-free-survival,PFS)、疾病控制率(disease control rate,DCR)和治疗相关不良反应发生率。 结果 试验组和对照组DCR分别是94.1%和84.2%(P=0.24)。试验组和对照组中位PFS(mPFS)分别为12.1月和9.1月(P<0.05);亚组分析显示,对于19号外显子缺失的患者,试验组和对照组mPFS分别为10.5月和9.5月(P=0.17);但对于21号外显子点突变(L858R)的患者,两组mPFS分别为13.2月和7.8月(P<0.05)。试验组3~4级治疗相关不良反应发生率低于对照组,分别为8.33%和15.00%(P=0.65)。 结论 EGFR-TKIs联合中药可延长晚期非小细胞肺癌患者的PFS,对L858R患者的效果更好,值得进一步研究。

     

    Abstract: Objective To explore the curative effect of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKIs) combined with Traditional Chinese Medicine (TCM) versus single EGFR-TKIs for Advanced non-small-cell lung cancer (NSCLC). Methods A total of 59 NSCLC patients with EGFR mutation were divided (2:1) into treatment group and control group. Patients in treatment group (39 cases) take EGFR-TKIs plus TCM and control group (20 cases) take EGFR-TKIs. Analysis the progression-free survival (PFS), disease control rate (DCR) and treatment-related adverse events of two groups. Results The DCR of the treatment group and control group was 94.1% and 84.2% respectively (P=0.24). In the total population, PFS was 12.1 months in treatment group and 9.1 months in control grouphazard ratio (HR) 0.46; 95%CI 0.23-0.9; P=0.025. Among patients with exon 19 deletion (19-del), PFS between treatment group and control group was 10.5 months and 9.5 months respectively (P=0.17). For patients with exon Leu858Arg point mutation (L858R), PFS was significantly longer with treatment group than withcontrol group (median 13.2 months vs. 7.8 months; HR 0.32, 95%CI 0.10-0.97; P=0.046). Grade 3-4 treatment-related adverse events were less common withtreatment-group (8.33%) than control group (15.00%) (P=0.65). Conclusion For NSCLC patients with EGFR mutation, EGFR-TKIs combined with TCM has a certain effect to prolong PFS, especially for the patients with L858R.

     

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