克唑替尼治疗间变性淋巴瘤激酶阳性晚期非小细胞肺癌患者的临床疗效分析  

Clinical Efficacy of Crizotinib for Patients with Anaplastic Lymphoma Kinase-positive Advanced Non-small-cell Lung Cancer

作　　者：宋玲玲[1] 刘红梅[1] 黄媚娟[1] 王仙凤[1] 张新星[1] 任莉[1] 王瑾[1] 彭枫[1] 王永生[1] 卢铀[1] 

机构地区：[1]四川大学华西医院肿瘤中心胸部肿瘤科,成都610041

出　　处：《华西医学》2016年第1期43-47,共5页West China Medical Journal

摘　　要：目的探讨克唑替尼治疗间变性淋巴瘤激酶（ALK）融合基因阳性的晚期非小细胞肺癌（NSCLC）患者的临床疗效。方法收集2012年11月-2014年5月接受克唑替尼治疗的ALK阳性的晚期NSCLC患者。31例患者的中位年龄为51岁;男14例（45.2%）,女17例（54.8%）;不吸烟者占74.2%;74.2%的患者ECOG评分为0-2分。在病理组织分型中,腺癌占96.8%,大细胞癌占3.2%。有1例患者存在EGFR与ALK基因共同突变。一线口服克唑替尼的患者有15例（48.4%）,二线及二线以上口服克唑替尼的患者有16例（51.6%）。结果接受克唑替尼治疗的患者客观有效率（ORR）为61.3%,疾病控制率（DCR）为90.3%,中位无疾病进展时间（PFS）为10.0个月[95%CI（2.9,17.0）个月]。一线口服克唑替尼的患者与二线及以上口服克唑替尼的患者之间的ORR和DCR差异无统计学意义（P=0.716,P=0.600）。克唑替尼的不良反应主要为谷草转氨酶/谷丙转氨酶比值升高（64.5%）、恶心呕吐（35.5%）、白细胞降低（16.7%）、视觉改变（16.1%）、肢体水肿（12.9%）、腹泻（12.9%）等,大部分分级为1-2级。结论克唑替尼可以有效治疗ALK阳性晚期NSCLC患者,提高ORR和DCR,延长PFS,且毒性作用较小,患者耐受性好。Objective To explore the therapeutic efficacy of crizotinib for patients with anaplastic lymphoma kinase（ALK）-positive advanced non-small-cell lung cancer（NSCLC）.Methods We retrospectively analyzed the clinical data of 31 ALK-positive NSCLC patients who received crizotinib treatment between November 2012 and May 2014 in the Department of Thoracic Oncology of West China Hospital.The median age of the patients was 51 years old,and the percentage of male and female patients was 45.2%and 54.8%,respectively.Among them,74.2%were non-smokers,74.2%had an ECOG performance status of 0- 2.Histologically,adenocarcinoma was the highest proportion of 96.8%,and one（3.2%） patient had large cell carcinoma.Fifteen（48.4%） ALK-positive patients were given crizotinib in the first-line setting,and 16（51.6%） accepted crizotinib in the second-line and beyond.Results The objective response rate（ORR）of the patients treated with crizotinib was 61.3%,and the disease control rate（DCR） was 90.3%.The median progressionfree survival（time） was 10.0 months[（95%CI（2.9,17.0） months].The difference of ORR and DCR between the patients given crizotinib in the first-line setting and the patients given crizotinib in the second-line or beyond was not statistically significant（P= 0.716 and P= 0.600,respectively）.The most frequent treatment-related adverse events were increased aspartate aminotransferase/alanine aminotransferase（64.5%）,nausea and vomiting（35.5%）,leukopenia（16.7%）,vision disorder（16.1%）,edema（12.9%）,and diarrhea（12.9%）,and most toxicities were grade 1 and 2.Conclusions This study shows that crizotinib can increase the objective response rate and disease control rate,prolong progression-free survival time in patients with advanced ALK-positive non-small-cell lung cancer.Crizotinib has relative fewer side effects and can be tolerated by the patients.

关 键 词：间变性淋巴瘤激酶 非小细胞肺癌 克唑替尼 不良反应 

分 类 号：R734.2[医药卫生—肿瘤]