CAJ | 학술논문

目的观察厄洛替尼与长春瑞滨治疗表皮生长因子受体(EGFR)突变的老年非小细胞肺癌(NSCLC)患者的治疗效果及不良反应. 方法 64例经病理学确诊且EGFR基因突变(19外显子缺失或L858R点突变)的老年晚期NSCLC患者,随机分为两组,厄洛替尼组43例,服用厄洛替尼(150 mg,口服,每天1次)治疗直至病情进展或出现严重不良反应；对照组21例,给予以长春瑞滨为主的两药联合方案或单药化疗. 结果厄洛替尼组和对照组的有效率分别为78.6 ％(33 /42)和38.1％(8/21),疾病控制率分别为88.1 ％(37/42)和61.9％(13/21),差异有统计学意义(x2值分别为10.09、5.37,均P＜0.05)；无进展生存期分别为11.6个月和5.6个月,差异也有统计学意义(x2=18.18,P＜0.001)；中位生存期分别为19.0个月和16.5个月,两组差异无统计学意义(x2=1.69,P=0.193).药物不良反应多为Ⅰ、Ⅱ度,无因不良反应需停药者,未发现药物相关死亡.厄洛替尼组的不良反应主要为皮疹30例(71.4％)、腹泻13例(31.0％)、肝功能异常10例(23.8％),对照组的不良反应主要为中性粒细胞减少14例(66.7％)、恶心或呕吐10例(47.6％)、贫血9例(42.9％)、血小板下降7例(33.3％)、便秘7例(33.3％)、周围神经炎5例(23.8％),对照组较厄洛替尼组有更多的3～4级不良反应患者,分别为1 5例(71.4％)和7例(16.7％)(x2＝1.69,P=0.193). 结论厄洛替尼用于治疗EGFR突变的老年晚期NSCLC患者的客观有效率、疾病控制率、疾病进展时间优于化疗组,中位生存期无差异,且不良反应发生率相对减少,可作为EGFR敏感突变的老年晚期NSCLC患者一线治疗的合理方案.
목적 관찰액락체니여장춘서빈치료표피생장인자수체(EGFR)돌변적노년비소세포폐암(NSCLC)환자적치료효과급불량반응. 방법 64례경병이학학진차EGFR기인돌변(19외현자결실혹L858R점돌변)적노년만기NSCLC환자,수궤분위량조,액락체니조43례,복용액락체니(150 mg,구복,매천1차)치료직지병정진전혹출현엄중불량반응；대조조21례,급여이장춘서빈위주적량약연합방안혹단약화료. 결과 액락체니조화대조조적유효솔분별위78.6 ％(33 /42)화38.1％(8/21),질병공제솔분별위88.1 ％(37/42)화61.9％(13/21),차이유통계학의의(x2치분별위10.09、5.37,균P＜0.05)；무진전생존기분별위11.6개월화5.6개월,차이야유통계학의의(x2=18.18,P＜0.001)；중위생존기분별위19.0개월화16.5개월,량조차이무통계학의의(x2=1.69,P=0.193).약물불량반응다위Ⅰ、Ⅱ도,무인불량반응수정약자,미발현약물상관사망.액락체니조적불량반응주요위피진30례(71.4％)、복사13례(31.0％)、간공능이상10례(23.8％),대조조적불량반응주요위중성립세포감소14례(66.7％)、악심혹구토10례(47.6％)、빈혈9례(42.9％)、혈소판하강7례(33.3％)、편비7례(33.3％)、주위신경염5례(23.8％),대조조교액락체니조유경다적3～4급불량반응환자,분별위1 5례(71.4％)화7례(16.7％)(x2＝1.69,P=0.193). 결론 액락체니용우치료EGFR돌변적노년만기NSCLC환자적객관유효솔、질병공제솔、질병진전시간우우화료조,중위생존기무차이,차불량반응발생솔상대감소,가작위EGFR민감돌변적노년만기NSCLC환자일선치료적합리방안.
Objective To compare the efficacy and adverse effects of erlotinib versus vinorelbine naive patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) mutation.Methods Totally 46 elderly patients with histologically confirmed advanced NSCLC and EGFR mutations (exon 19 dclction or L858R point mutation) were enrolled.Patients were randomly divided into two groups:erlotinib group (43 cases,150mg per day until disease progression or unacceptable toxicities) and control group (21 cases,vinorelbine-based chemotherapy,single vinorelbine chemotherapy or vinorelbine-based double chemotherapy).Results Response rates and disease control rates were significantly improved with erlotinib compared with vinorelbine (78.6％ and 88.1％ vs.38.1％ and 61.9％,respectively,P＜ 0.05).There was a significant difference in median progression-free survival (11.6 months vs.5.6 months,P＜0.05),while no statistical difference in median overall survival with erlotinib compared with vinorelbine (19.0months vs.16.5 months,P=0.193).The most frequent adverse effects were grade Ⅰ or Ⅱ and no patients stopped treatment due to adverse effects and no drug-relatcd death.The primary adverse effects were skin rash (71.4％),diarrhea (31.0％)and liver dysfunction (23.8％) in the erlotinib group and neutropenia (66.7％),nausea or vomit (47.6％),anemia (42.9％),platelet decline (33.3％),constipation (33.3％) and peripheral neuritis (23.8％) in the vinorelbine group.Vinorelbine group versus erlotinib group have more 3-4 level adverse reactions (15/21 vs.7/42)(x2=1.69,P=0.193).Conclusions Erlotinib treatment has advances in PFS,ORR and DCR and tolerability compared with vinorelbine-based chemotherapy in elderly patients with advanced NSCLC and EGFR mutation,while overall survival is in no difference.Erlotinib may be a reasonable first-line treatment option for elderly patients with advanced NSCLC and sensitive EGFR mutation.