中药联合吉非替尼治疗晚期EGFR突变非小细胞肺癌:随机对照试验

摘要：

Backgmund:Patients with non-small cell lung cancer with epidermal growth factor receptor(EGFR) gene mutation respond well to the EGFR tyrosine kinase inhibitor gefitinib.Traditional Chinese medicine(TCM) is used as complementary and alternative therapy for cancer patients in South China.The purpose of this study is to determine if ”Fuzheng Kang”ai(FZKA,a traditional Chinese herbal medicine)” decoction plus gefitinib have longer progression-free survival and with less toxicity than gefitinib alone.Methods:We conducted a randomized,controlled trial with recruitment between January 1,2009,and February 28,2012,in South China.60 chemotherapy-naive patients diagnosed with stage ⅢB/Ⅳ non-small cell lung cancer with EGFR mutations(either the exon 19 deletion or L858R point mutation) were randomly assigned to receive either gefitinib plus FZKA(G,250 mg/day orally;F,250ml/bid/day orally;n=30) or gefitinib(G,250 mg/day orally;n=30) alone.The primary endpoint was Pmgression-free survival(PFS),second endpoints were median survival time(MST),objective responserate(ORR),disease control rate(DCR) and safety.Results:No patient was excluded after randomization.Thus,60 patients(30 in each group) were included in the survival analyses.The GF group hadsignificantly longer PFS and MST compared with the G group,with a median PFS of 10.2 months(95％CI 8.6-12.0) versus 7.9 months(95％ CI 6.2-9.6,log-rank P<0.05),MST of 16.8 months(95％ CI14.1-19.5) versus 13.2 months(95％ CI 10.5-15.9,log-rank P<0.05).The ORR and DCR in GF groupwere 66.7％,93.3％,and in G group were 60.0％,83.3％(P>0.05).The most common adverseevents in the GF groupwere rash or acne(in 43.3％ of patients) and diarrhea(13.3％),and in the G group,rash or acne (in 56.7％ of patients),diarrhea(36.7％),andstomatitis(3.3％)(P<0.05).Conclusions Patients with advanced non-small celllung cancer who are selected by EGFR mutations have longer progression-free survival,median survival time and with less toxicity if they are treated with gefitinib plus FZKA than if they are treated with gefitinib alone.

关键词： 非小细胞肺癌 中药治疗 吉非替尼 临床疗效

作者: Xiao-Bing Yang Qiu-Pin Li Yu-Shu Ouyang Jiao-Zhi Cai Shu-Jing Xiao Wan-Yin Wu Fu-Rui Li Xiao-shu Chai Shun-Qin Long Hong Deng Zong-Qi Pan Wen-Feng He Yu-Shu Zhou Gui-Ya Liao

会议类型: 国内会议

会议名称: 2013年全国中医肿瘤学术年会

会议地点: 北京

会议语种:中文

页码: 93-100

在线出版日期: 2013-09-06（万方平台首次上网日期，不代表论文的发表时间）