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Randomized Controlled Trial
. 2013 Aug 20;16(8):405-10.
doi: 10.3779/j.issn.1009-3419.2013.08.03.

[A randomized clinical study of Gefitinib and pemetrexed as second line therapy for advanced non-squamous non-small cell lung cancer]

[Article in Chinese]
Hongyu Dai  1 , Ling Xu, Chunwei Xia, Wenping Chen
Affiliations
Randomized Controlled Trial

[A randomized clinical study of Gefitinib and pemetrexed as second line therapy for advanced non-squamous non-small cell lung cancer]

[Article in Chinese]
Hongyu Dai et al. Zhongguo Fei Ai Za Zhi. .

Abstract
in English, Chinese

Background and objective: Gefitinib and Pemetrexed are drugs used as second-line therapy for advanced non-small cell lung cancer (NSCLC), although studies comparing the two drugs are limited. The aim of this study is to explore the effects, safety, and quality of life (QoL) of Gefitinib and Pemetrexed on patients with advanced non-squamous NSCLC.

Methods: Forty-six advanced non-squamous NSCLC patients who failed to first-line therapy were randomly divided into two groups with 23 patients each, one using oral Gefitinib (Gefitinib group) and the other using intravenous injection Pemetrexed (Pemetrexed group). The effects, safety, and QoL were determined and analyzed.

Results: For the Pemetrexed group, objective response rate (ORR) was 13.0% (3/23), disease control rate (DCR) was 30.4% (7/23), and median progression-free survival (mPFS) was 3.1 months. In the Gefitinib group, ORR was 17.3% (4/23), DCR was 39.1% (9/23), and mPFS was 4.4 months. Compared with the Pemetrexed group, the ORR, DCR, and mPFS in the Gefitinib group exhibited no statistical significance (P>0.05). Furthermore, the most common toxicities in the Pemetrexed group were neutropenia (n=9, 39.13%) and fatigue (n=8, 34.78%), whereas those in the in Gefitinib group were skin rash (n=8, 34.78%) and diarrhea (n=4, 17.39%). Compared with baseline, the QoL improved in both groups but to different degrees. Likewise, emotional, functional well-being, and QoL aspects specifically related to lung cancer were better improved in the Gefitinib group than in the Pemetrexed group (P<0.05).

Conclusions: The effects of Pemetrexed and Gefitinib as second line therapy were similar, although with different AEs. Both drugs could improve the QoL, but Gefitinib showed better overall results than Pemetrexed.

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（objective response rate, ORR）为 13.0%（3/23），疾病控制率（disease control rate, DCR）为30.4% （7/23），中位无进展生存时间（median progression-free survival, mPFS）为3.1个月；吉非替尼组的ORR 17.3%（4/23），DCR 39.1%（9/23），mPFS 4.4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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Figures

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无进展生存时间的Kaplan-Meier生存曲线 Kaplan-Meier survival curve of progressive-free survival (PFS)
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