【作者】 杨小兵； 吴万垠； 龙顺钦； 邓宏； 潘宗奇； 河文峰； 周宇姝； 廖桂雅； 李秋萍； 肖舒静； 蔡姣芝；

【Author】 YANG Xiao-bing;WU Wan-yin;LONG Shun-qin;DENG Hong;PAN Zong-qi;HE Wen-feng;ZHOU Yu-shu;LIAO Gui-ya;LI Qiu-pin;XIAO Shu-jing;CAI Jiao-zhi;Oncology Department,Guangdong provincial hospital of Traditional Chinese Medicine;

【机构】 广东省中医院肿瘤科；

【摘要】 目的:了解扶正抗癌方联合吉非替尼的无进展生存期及总生存期是否优于吉非替尼单药组。方法:采用回顾性病例匹配队列研究的方法,以性别、年龄段、吸烟状态、PS评分及病理因素为配对因子进行配对。配对50组以上mb-Ⅳ期非小细胞肺癌患者,分成治疗组及对照组。治疗组接受吉非替尼联合扶正抗癌方(扶正抗癌方,200ml bid po+吉非替尼250mg qd po),连续服至病情进展或不能耐受毒副反应。对照组接受吉非替尼单药治疗(吉非替尼250mg qd po),服药至疾病进展。治疗前及之后每6周复查胸部CT评价疗效。首要终点为疾病无进展生存时间(PFS);次要终点为中位生存期(MST)、客观反应率(ORR)及毒性反应。结果:自2007年7月1日至2012年12月31日,配对成功58对,1例因年龄小(患者年龄为27岁)而无法配对成功。接受单纯吉非替尼组的客观反应率(CR+PR)为82.76%,而接受吉非替尼联合扶正抗癌方的客观反应率为(CR+PR)为74.14%,组间差异无统计学差异(P=0.527)。最常见的不良反应是皮疹及腹泻,其次是口腔黏膜炎及转氨酶升高。吉非替尼组皮疹的发生率为41.38%,吉非替尼联合扶正抗癌方组的皮疹发生率为24.14%,组间差异具有统计学差异(P=0.048)。吉非替尼组的中位无进展生存时间是11.43个月,而吉非替尼联合扶正抗癌方组是13.1个月,二者差异具有统计学意义(P=0.013)。亚组分析发现,一线治疗时,吉非替尼组的中位疾病无进展生存时间是11.43个月,扶正抗癌方联合吉非替尼组是12.33个月,二者差异有统计学意义(P=0.024)。吉非替尼组的中位生存时间是1 8.7个月,而吉非替尼联合扶正抗癌方组是22.83个月,二者生存差异具有统计学意义(P=0.049)。亚组分析发现,EGFR基因未明患者,吉非替尼组的中位生存时间是20.27个月,吉非替尼联合扶正抗癌方组是23.73个月,二者生存差异具有统计学意义(P=0.018)。结论:吉非替尼联合中药扶正抗癌方治疗晚期非小细胞肺癌的客观反应率与吉非替尼单药相似,联合治疗组皮疹发生率低于吉非替尼单药组,提示扶正抗癌方对吉非替尼有减毒作用。吉非替尼联合扶正抗癌方组在整体人群的疾病无进展时间及中位生存时间较单纯吉非替尼组长,提示扶正抗癌方对吉非替尼有增效作用。更多还原

【Abstract】 Objective:This study aims to explore whether the progression-free survival(PFS) or overall survival(OS) of gefitinib plus FuZhen KangAi Decotion(GF)group is better than that of gefitinib(G) group.Methods:We matched more than 50 groups of stage Ⅲb or Ⅳ non-small cell lung cancer patients with the method of retrospective case-matching cohort study.The matching factors included gender,age,smoking status,performance status(PS) and pathological factors.The patients were divided into the treatment group(GF) and control group(G).Patients in GF group received gefitinib(G,250 mg/day orally) plus FZKA(F,200 ml/bid/day orally),while in G group only received gefitinib(G,250 mg/day orally).Gefitinib or FZKA was administered until progression of the disease,or development of unacceptable toxicities.CT scan was performed eviery 6 weeks to evaluate the effect.The primary endpoint was progression-free survival(PFS),secondary ehdpoirits were median survival time(MST),objective response rate and safety.Results:From July 2007 to December 2012,58 pairs were matched successfully.1 patient with the age of 27 years failed to be matched.The objective response rate(CR + PR) in the G group was82.76%,while in GF group was 74.14%.There was no statistically difference between two groups(P = 0.527).The most common adverse events were rash and diarrhea.The second were stomatitis and aminotransferase elevation.The incidence of rash in G group was 41.38%,while in GF group was 24.14%.There was statistically difference between two groups(P=0.048).The median progression-free survival time in the G group was 11.43 months,while in GF group was 13.1 months.There was statistically difference between two groups(P=0.013).Subgroup analyses showed that the median progression-free survival time of the G group was 11.43 months and of the GF group was 12.33 months in the first-line treatment,,there was statistically difference between two groups(P=0.024).The median survival time in G group was18.7 months while in group was 22.83 months up to the last follow-up time.There was statistically difference between two groups(P=0.049).Subgroup analyses showed that the median overall survival time of the G group was 20.27 months and in GF group was 23.73 months in patients whose EGFR gene statuses were unknown,there was statistically difference between two groups(P=0.018).Conclusion:The objective response rate of gefitinib combined with Fuzheng Kang’ai decoction is similar to gefitinib in patient with advanced non-small cell lung cancer.The incidence of rash in GF group was lower than that in G group.The result suggests that Fuzheng Kang’ai decoction can decrease toxicity of gefitinib.The progression-free survival and overall survival in GF group are longer than that in G group,which suggests that Fuzheng Kang’ai decoction can improve the effect of gefitinib.更多还原