CAJ | 학술논문

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。
배경여목적길비체니화배미곡새균시만기비소세포폐암（non-small cell lung cancer, NSCLC）이선치료적약물，단직접대비량자이선치료적연구수거유한。본연구지재비교길비체니화배미곡새이선치료만기비린형NSCLC적료효、안전성급대생활질량적영향。방법장46례일선함박쌍약화료방안（불함배미곡새）치료실패적만기비린형NSCLC환자수궤분위량조，매조23례，분별급여길비체니구복（길비체니조），혹정맥적주배미곡새（배미곡새조），비교량조적료효화안전성급치료대생활질량적영향。결과배미곡새조적객관완해솔（objective response rate, ORR）위13.0%（3/23），질병공제솔（disease control rate, DCR）위30.4%（7/23），중위무진전생존시간（median progression-free survival, mPFS）위3.1개월；길비체니조적ORR 17.3%（4/23），DCR 39.1%（9/23），mPFS 4.4개월；량조적ORR、DCR화mPFS균미견통계학차이（P>0.05）。배미곡새최상견적불량반응위중성립세포감소（n=9,39.13%）화핍력（n=8,34.78%）；길비체니최상견적불량반응위피진（n=8,34.78%）화복사（n=4,17.39%）。화치료전기선상비，배미곡새조화길비체니조치료후생활질량평분균유불동정도적개선，길비체니조재정서，활동능력급폐암부가관주적기타인소방면교배미곡새조개선경명현（P<0.05）。결론길비체니화배미곡새이선치료만기비린형NSCLC적료효상사，불량반응각이；량자균능개선환자적생활질량，단시길비체니개선경명현。
Background and objective Geiftinib and Pemetrexed are drugs used as second-line therapy for ad-vanced non-small cell lung cancer (NSCLC), although studies comparing the two drugs are limited. hTe aim of this study is to explore the effects, safety, and quality of life (QoL) of Geiftinib and Pemetrexed on patients with advanced non-squamous NSCLC. Methods Forty-six advanced non-squamous NSCLC patients who failed to ifrst-line therapy were randomly divided into two groups with 23 patients each, one using oral Geiftinib (Geiftinib group) and the other using intravenous injection Pemetrexed (Pemetrexed group). hTe 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 progres-sion-free survival (mPFS) was 3.1 months. In the Geiftinib 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 Geiftinib group exhibited no statisti-cal signiifcance (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 Geiftinib 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 speciifcally related to lung cancer were better improved in the Geiftinib group than in the Pemetrexed group (P<0.05). Conclusion hTe effects of Pemetrexed and Geiftinib as second line therapy were similar, although with dif-ferent AEs. Both drugs could improve the QoL, but Geiftinib showed better overall results than Pemetrexed.