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吉非替尼对比培美曲塞二线治疗晚期非鳞型非小细胞肺癌的随机对照临床研究
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吉非替尼对比培美曲塞二线治疗晚期非鳞型非小细胞肺癌的随机对照临床研究
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吉非替尼对比培美曲塞二线治疗晚期非鳞型非小细胞肺癌的随机对照临床研究
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Journal Article
吉非替尼对比培美曲塞二线治疗晚期非鳞型非小细胞肺癌的随机对照临床研究
2013
Overview
背景与目的吉非替尼和培美曲塞均是晚期非小细胞肺癌（non-small cell lung cancer,NSCLC）二线治疗的药物,但直接对比两者二线治疗的研究数据有限。本研究旨在比较吉非替尼和培美曲塞二线治疗晚期非鳞型NSCLC的疗效、安全性及对生活质量的影响。方法将46例一线含铂双药化疗方案（不含培美曲塞）治疗失败的晚期非鳞型NSCLC患者随机分为两组,每组23例,分别给予吉非替尼口服（吉非替尼组）,或静脉滴注培美曲塞（培美曲塞组）,比较两组的疗效和安全性及治疗对生活质量的影响。结果培美曲塞组的客观缓解率（objectiveresponserate,ORR）为13.0%（3/23）,疾病控制率（diseasecontrolrate,DCR）为30.4%（7/23）,中位无进展生存时间（medianprogression-freesurvival,mPFS）为3.1个月;吉非替尼组的ORR17.3%（4/23）,DCR39.1%（9/23）,mPFS4.4个月;两组的ORR、DCR和mPFS均未见统计学差异（P〉0.05）。培美曲塞最常见的不良反应为中性粒细胞减少（n=9,39.13%）和乏力（n=8,34.78%）;吉非替尼最常见的不良反应为皮疹（n=8,34.78%）和腹泻（n=4,17.39%）。和治疗前基线相比,培美曲塞组和吉非替尼组治疗后生活质量评分均有不同程度的改善,吉非替尼组在情绪,活动能力及肺癌附加关注的其它因素方面较培美曲塞组改善更明显（P〈0.05）。结论吉非替尼和培美曲塞二线治疗晚期非鳞型NSCLC的疗效相似,不良反应各异;两者均能改善患者的生活质量,但是吉非替尼改善更明显。
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