扶正抗癌颗粒联合吉非替尼治疗晚期非小细胞肺癌随机双盲对照试验

Effect of Fuzheng Kang'ai Granule and Gefitinib on Non-small Cell Lung Cancer:A Randomized Double-blinded Controlled Trial

目的评价扶正抗癌颗粒联合吉非替尼治疗表皮细胞生长因子受体(EGFR)基因突变晚期非小细胞肺癌(NSCLC)患者疗效。方法采用随机、双盲、安慰剂对照的方法,纳入EGFR基因突变的晚期NSCLC患者70例,随机分为治疗组(吉非替尼+扶正抗癌颗粒)和对照组(吉非替尼+安慰剂颗粒剂)。治疗至肿瘤进展或发生不可耐受的毒副反应或死亡。观察两组患者疾病控制率(DCR)、疾病无进展生存时间(PFS)及毒性反应。结果治疗组与对照组DCR分别为93.90%和90.30%,两组差异无统计学意义(P>0.05)。治疗组PFS为13.5个月,对照组PFS是11.7个月,两组差异有统计学意义(P<0.05)。治疗组2例患者出现皮疹,对照组中8例患者出现皮疹,两组差异有统计学意义(P<0.05)。结论扶正抗癌颗粒联合吉非替尼在可延长EGFR突变晚期NSCLC患者PFS,减轻酪氨酸激酶抑制剂引起的不良反应。

Objective To evaluate the efficacy of Fuzheng Kang'ai Granule and Gefitinib in the treatment of advanced non-small cell lung cancer(NSCLC)patients with epidermal growth factor receptor(EGFR)gene mutation.Methods A randomized double-blinded controlled trial was conducted.Seventy advanced NSCLC patients with EGFR gene mutation were randomly assigned to experimental group(Gefitinib+Fuzheng Kang'ai Granule)and control group(Gefitinib+placebo).Treatment were given until cancer progression,intolerable toxic side effects or death.The disease control rate(DCR),progression-free survival(PFS)and toxicity of two groups were observed.Results The DCR of the treatment group and the control group were 93.90%and 90.30%,respectively,but without significant difference(P>0.05).The median PFS was 13.5 months in the treatment group and 11.7 months in the control group,there were significant differences between the two groups(P<0.05).Two patients in the treatment group and 8 patients in the control group had skin rash,and the difference was significant(P<0.05).Conclusion Fuzheng Kang'ai Granule combined with Gefitinib can prolong the PFS of NSCLC patients with EGFR gene mutation,alleviate toxicity and side effects caused by tyrosine kinase inhibitor.