【作者】 吴万垠； 罗飞燕； 龙顺钦； 杨小兵； 邓宏； 蔡姣芝； 潘宗奇； 河文峰； 周宇姝； 欧阳育树； 廖桂雅；

【机构】 广东省中医院肿瘤科；

【摘要】 目的:观察扶正抗癌方联合吉非替尼治疗难治性晚期非小细胞肺癌的临床疗效及不良反应。方法:对2009年3月至2011年9月在广东省中医院收治的35例拒绝化疗的EGFR突变未明的吸烟或非腺癌以及EGFR突变阴性的ⅢB/Ⅳ期NSCLC患者,口服扶正抗癌方(1剂/d)及吉非替尼(250mg/d),直至疾病进展或出现不可耐受的不良反应。观察ORR、DCR、PFS、OS、1年生存率及毒副反应。结果:随访截至2012年2月1日,32例(91.4%)出现疾病进展,27例(77.1%)死亡。32例患者可评价近期疗效,ORR为15.6%,DCR为59.4%。总体中位PFS为4.9(95%CI 4.0-5.9)月,中位0S为10.9(95%CI3.7-18.0)月,1年生存率为47.0%。治疗过程中共有20例(57.1%)出现不良反应,其中Ⅰ~Ⅱ度皮疹19例(54.3%),轻度腹泻2例(5.7%),没有患者因不良反应终止治疗。结论:扶正抗癌方联合吉非替尼治疗EGFR突变未明的吸烟或非腺癌以及EGFR突变阴性的晚期NSCLC患者的疗效确切,毒副反应小,值得进一步临床研究。更多还原

【Abstract】 Objective To evaluate the efficacy and toxicity of "FuZhengKangAi" decoction combined with Gefitinib in treatment of refractory advanced NSCLC.Methods From Mar 2009 to Sep2011,35 patients with ⅢB~Ⅳ NSCLC who were EGFR wild-type or had clinical factors associated with lower incidence of EGFR mutations(smokers or non-adenocarcinoma histology) in Guangdong Traditional Chinese Medical Hospital were eligible.All patients had refused treatment of chemotherapy.In this study,patients were treated with "FuZhengKangAi" decoction 250ml/d combined with Gefitinib250mg/d until disease progression,unacceptable toxicity or withdrawal of consent.The ORR,DCR,PFS,OS,1-year survival rate and adverse effect were analyzed.Results Of the 35 patients,10(28.6%) were known as EGFR wild-type.At the end of follow-up on the 1st Feb 2012,32(91.4%) had disease progression,27(77.1%) died of lung cancer.32(91.4%) can be evaluated efficacy,in which the ORR was 15.6%and the DCR was 59.4%.The mPFS was 4.9(95%CI 4.0-5.9) months,the median OS was10.9(95%CI 3.7-18.0) months,and the 1-year survival rate was 47.0%.During the study,20(57.1%)patients were recorded of adverse reaction.The toxicity was I ~II rank rash(54.3%) and diarrhea(5.7%).No patient discontinued treatment due to toxicity.Conclusion The "FuZhengKangAi" decoction combined with Gefitinib in the refractory advanced NSCLC patients who were EGFR wild-type or had clinical factors associated with lower incidence of EGFR mutations(smokers or non-adenocarcinoma histology) had better efficacy and lower toxicity,the therapy method was worthy to be popularized.更多还原