评估吉非替尼交替化疗对比化疗治疗Ⅳ期非小细胞肺癌的疗效及安全性  

Evaluation of efficacy and safety of Gifitinib intercalate chemotherapy versus chemotherapy alone against NSCLC(Ⅳ)

作　　者：朱亚宁[1] 张鹏[1] 张丹[1] 尤海生[2] 李东辉[3] 何恒[1] 李黎[1] 

机构地区：[1]陕西省人民医院药学部,陕西西安710068 [2]西安交通大学医学院第一附属医院药学部,陕西西安710061 [3]陕西省人民医院肿瘤内科,陕西西安710068

出　　处：《中国医院药学杂志》2016年第6期480-484,共5页Chinese Journal of Hospital Pharmacy

基　　金：陕西省自然科学基金资助项目(编号:2013JM4052)

摘　　要：目的：比较吉非替尼交替化疗与单纯化疗在Ⅳ期非小细胞肺癌（Non-small cell lung cancer,NSCLC）患者治疗中的疗效和安全性。方法：回顾分析2013年9月-2014年9月Ⅳ期表皮生长因子受体（Epidermal growth factor receptor,EGFR）突变阳性NSCLC患者病历59例,依治疗方案分为2组：对照组（n=30）：培美曲塞（500 mg·m^-2,iv,d1）,顺铂（75 mg·m^-2,iv,d1）,21 d为1个周期,治疗4～6个周期;观察组（n=29）：化疗方案同对照组,加用吉非替尼（250 mg,po,d2～15）,比较2组的客观缓解率（ORR）、疾病控制率（DCR）、中位无进展生存期（PFS）及药物不良反应（ADR）。结果：观察组和对照组的ORR分别为51.7%、16.7%（P=0.004）,DCR分别为93.1%和86.7%（P=0.413）,中位PFS分别为15.5个月和8.0个月（P=0.001）;观察组外显子19 LREA缺失的患者疗效及耐受性优于21 L858R突变的患者,患者突变位点不同,ADR临床表现存在较大差异,严重ADR的发生率为13.79%。结论：吉非替尼交替化疗较单纯化疗对EGFR突变阳性的Ⅳ期NSCLC患者的疗效更好,其中对外显子19 LREA缺失疗效最优。OBJECTIVE To compare efficacy and safety of Gifitinib intercalate chemotherapy versus chemotherapy alone against non-small cell lung cancer（NSCLC）at stageⅣ.METHODS Fifty nine NSCLC patients in of stageⅣ were retrospectively analyzed from September 2013 to September 2014.All patients were EGFR mutation positive.Therapeutic regimen：control group（n=30）,pemetrexed（500 mg·m^-2,iv,d1）,cisplatin（75 mg·m^-2,iv,d1）,one period of chemotherapy lasted for21 days,and the whole course was composed of 4 to 6 cycles;test group（n=29）,chemotherapy was the same with that of control group,but Gifitinib（250 mg,po,d2-15）was added.Overall response rate（ORR）,disease control rate（DCR）,median progression-free survival（PFS）and adverse reactions were compared between two groups.RESULTS ORR of test and control groups were 51.7% and 16.7%（P=0.004）,DCR were 93.1% and 86.7%（P=0.413）,median PFS were 15.5 and8.0months（P=0.001）,respectively.Efficacy and tolerability of EGFR19 exon deletion in test group was better than that of21 L858 R mutation.Significant difference was observed in ADR symptom and sign in patients with different site mutations.The ratio of serious adverse drug reactions was 13.79%.CONCLUSION Gifitinib intercalate chemotherapy shows more benefits in patients of stageⅣ NSCLC with ORR and FPS of EGFR positive mutations than chemotherapy alone,especially in patients with EGFR19 exon deletion mutation.

关 键 词：吉非替尼交替化疗 Ⅳ期非小细胞肺癌 不良反应 临床疗效 

分 类 号：R969[医药卫生—药理学]