CAJ | 학술논문

目的：评价吉非替尼对比多西他赛联合顺铂化疗治疗表皮生长因子受体（ EGFR）突变晚期非小细胞肺癌（ NSCLC）的临床疗效和安全性。方法入选EGFR突变晚期非小细胞肺癌患者43例，分为试验组22例和对照组21例。试验组口服吉非替尼250 mg? d－1；对照组静脉滴注多西他赛60 mg? m－2联合顺铂80 mg? m－2，21 d为一个周期，直至出现不可耐受的不良反应或疾病进展。比较2组的客观缓解率、疾病无进展生存时间和药品相关不良反应。结果试验组客观缓解率为59．1％，疾病控制率为90．9％；对照组分别为33．3％和76．2％，试验组显著高于对照组（ P＜0．05）。试验组中位疾病无进展生存时间为11．95个月，显著长于对照组的6．90个月（ HR＝0．49，95％CI：0．24～1．0， P＜0．05）。试验组3～4级主要不良反应为皮疹和腹泻，对照组主要不良反应为白细胞减少和贫血，对照组白细胞减少发生率显著高于试验组（ P＜0．05）。结论吉非替尼治疗EGFR突变的晚期非小细胞肺癌疗效更好，可显著延长患者疾病无进展生存时间。
목적：평개길비체니대비다서타새연합순박화료치료표피생장인자수체（ EGFR）돌변만기비소세포폐암（ NSCLC）적림상료효화안전성。방법입선EGFR돌변만기비소세포폐암환자43례，분위시험조22례화대조조21례。시험조구복길비체니250 mg? d－1；대조조정맥적주다서타새60 mg? m－2연합순박80 mg? m－2，21 d위일개주기，직지출현불가내수적불량반응혹질병진전。비교2조적객관완해솔、질병무진전생존시간화약품상관불량반응。결과시험조객관완해솔위59．1％，질병공제솔위90．9％；대조조분별위33．3％화76．2％，시험조현저고우대조조（ P＜0．05）。시험조중위질병무진전생존시간위11．95개월，현저장우대조조적6．90개월（ HR＝0．49，95％CI：0．24～1．0， P＜0．05）。시험조3～4급주요불량반응위피진화복사，대조조주요불량반응위백세포감소화빈혈，대조조백세포감소발생솔현저고우시험조（ P＜0．05）。결론길비체니치료EGFR돌변적만기비소세포폐암료효경호，가현저연장환자질병무진전생존시간。
Objective To discussed clinical efficacy and safety of gefinitib compared with chemotherapy in the treatment of non-small-cell lung cancer ( NSCLC) harboring mutations of epidermal growth factor receptor( EGFR) .Methods A total of 43 NSCLC patients harboring mutations of EGFR were included in this study and divided into treatment group ( n=22 ) and control group ( n=21 ) .Patients in the treatment group received gefinitib 250 mg? d-1 orally, and those in control group were administered with docetaxe 60 mg? m-2 plus cisplatin 80 mg? m-2 intravenously until progression or unbearable adverse reactions.The data of objective response rate, progression free survival and adverse reactions were compared between the two groups.Results The objective response rate and disease control rate was 59.1%, 90.9%in treatment group and 33.3%, 76.2% in control group, respectively.The objective response rate was significantly higher in treatment group compared to that in control group ( P<0.05 ) .The median progression free survival time was 11.95 months and 6.90 months in treatment group and control group, respectively, which showed that the survial time in the treatment group was much longer (HR=0.49, 95%CI:0.24-1.01, P<0.05).The main grade 3-4 adverse reactions were rash and diarrhea in treatment group and leucocytopenia and anemia in control group.The incidence rate of leucocytopenia was significantly higher in control group than that in treatment group (P<0.05).Conclusion Gefinitib treatment for NSCLC harbouring mutations of EGFR has longer progression free survival and better efficacy.