吉非替尼对比培美曲塞治疗晚期非鳞非小细胞肺癌的临床疗效及安全性评价  

Clinical efficacy and safety of gefitinib versus pemetrexed second line treatment of non-small cell lung cancer

作　　者：刘孝民[1] 

机构地区：[1]河南科技大学第一附属医院肿瘤外科,河南洛阳471003

出　　处：《中国临床药理学杂志》2015年第24期2393-2395,共3页The Chinese Journal of Clinical Pharmacology

基　　金：河南省科技计划攻关基金资助项目(20103144)

摘　　要：目的比较吉非替尼与培美曲塞治疗晚期非鳞非小细胞肺癌的临床疗效及安全性。方法将42例既往含铂化疗失败的晚期非鳞非小细胞肺癌患者随机分为试验组20例和对照组22例。试验组予以口服吉非替尼250 mg,每日一次,连续服用至疾病进展或出现不可耐受性不良反应。对照组予以静脉滴注500 mg·m^(-2)培美曲塞,第1,21天重复一次,直至患者出现疾病进展或不可耐受不良反应。比较2组患者的临床疗效及化疗相关不良反应的发生情况。结果治疗后,试验组的客观缓解率为20.00%(4/20),疾病控制率为35.00%(7/20)对照组的客观缓解率为13.64%(3/22),疾病控制率为36.36%(8/22),2组比较差异均无统计学意义(P>0.05)。试验组与对照组的中位无进展生存时间分别为13.60周和13.20周(P>0.05)。试验组的不良反应为皮疹8例(40.00%)和腹泻3例(15.00%)对照组的不良反应为粒细胞减少8例(36.36%)和乏力9例(40.91%,P>0.05)。结论吉非替尼与培美曲塞治疗晚期非鳞非小细胞肺癌的临床疗效相当,但不良反应各异。Objective To evaluated the activity and safety of gefitinib versus pemetrexed treatment of advanced non- squamous cell non- small cell lung cancer（NSCLC）.Methods Forty two non- squamous cell NSCLC patients previously treated with platinum based chemotherapy regimen were recruited in this study and randomly divided into experiment group（n =20） and control group（n =22）.Patients in the experiment group were administered gefitinib 250 mg orally per day until dead or progression.Patients in the control group were administered 500 mg·m^2pemetrexed intervenous drop infusion day 1 every 21 days until dead or progression.The clinical efficacy and drug associated toxicity was evaluated between the two groups.Results The objective response rate（ORR） and disease control rate（DCR） were 20.00%（4/20） and35.00%（7/20） in experiment group and 13.64%（3/22） and 36.36%（8/22） in control group.No statistical difference of ORR and DCR was found between the two groups（P〉0.05）.The median progression free survival was 13.60 week and 13.20 week in the experiment and control group respectively with no significant difference（P〉0.05）.The main adverse drug reactions were rash（40.00%） and diarrhea（15.00%） for experiment and granulocytopenia（36.36%） and debilitation（40.91%） for control group with no statistical difference（P〉0.05）.Conclusion There was no efficacy difference for gefitinib versus pemetrexed second line treatment of non- squamous cell non- small cell lung cancer with its own drug associated toxicity.

关 键 词：非小细胞肺癌 临床疗效 不良反应 吉非替尼 培美曲塞 

分 类 号：R979.1[医药卫生—药品] R734.2[医药卫生—药学]