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疗效与安全性分析  

Efficacy and safety of crizotinib in treatment of ALK-positive advanced NSCLC patients

作　　者：蒋小雯[1] 张俊华 王文娴[1] 张沂平[1] Jiang Xiaowen Zhang Junhua Wan Wenxian Zhang Yiping(Department of Thoracic Oneology, Zhejiang Cancer Hospital Affiliated to Zhefiang Chinese Medicine University, Hangzhou 310022, China （ Jiang XW, Wang WX, Zhang YP Department of Pediatrics, Hanggang Hospital, Hangzhou 310022, China （ Zhang JH)

机构地区：[1]浙江省肿瘤医院胸部肿瘤内科,杭州310022 [2]杭钢医院儿科,杭州310022

出　　处：《中华全科医师杂志》2016年第12期936-940,共5页Chinese Journal of General Practitioners

基　　金：浙江省中医药科研基金项目（2015ZB020）;浙江省自然基金（LY13H160024）

摘　　要：目的：探讨克唑替尼治疗间变性淋巴瘤激酶（ ALK ）融合基因阳性的非小细胞肺癌（NSCLC）患者的疗效和安全性。方法回顾性分析2013年9月1日至2015年10月31日期间就诊于浙江省肿瘤医院的47例接受口服克唑替尼（250 mg，2次／d）治疗的ALK阳性NSCLC患者，评价其疗效和不良反应。结果4.3％（2／47）患者完全缓解，66.0％（31／47）部分缓解，21.3％（10／47）病情稳定，8.5％（4／47）病情进展，客观缓解率为70.2％（33／47），疾病控制率达91.5％（43／47）。全部患者的中位无进展生存期（ PFS）为12.8个月。接受克唑替尼一线治疗和二线及以上治疗的患者的中位PFS分别为12.8和11.6个月，二者比较差异无统计学意义（χ2＝0.004，P＝0.947）。克唑替尼治疗前无脑转移患者及脑转移者的中位PFS分别为11.63、13.6个月，二者比较差异无统计学意义（χ2＝0.023，P＝0.881）。39例患者不良反应为ⅠⅡ度，主要表现为消化道症状：恶心、呕吐占40.4％（19／47），腹泻占19.1％（9／47）；其次为视觉闪烁（42.6％，20／47）；12.8％（6／47）患者出现ⅢⅣ度肝功能异常，4.3％（2／47）患者出现ⅢⅣ度骨髓抑制。结论克唑替尼作为ALK 融合基因阳性的NSCLC 患者的靶向治疗药，一线和二线及以上治疗的患者均能从中获益，具有较好的疗效及安全性。Objective To investigate the efficacy and tolerability of crizotinib in treatment of EML4-ALK-positive advanced non-small cell lung cancer （ NSCLC ） patient.Methods Clinical data of 47 NSCLC patients with positive ALK fusion gene receiving crizotinib （250 mg, q12h） treatment in Zhejiang Cancer Hospital from September 2013 to October 2015 were retrospectively analyzed.The efficacy and tolerability of crizotinib were evaluated.Results Among the 47 patients who were included in final analysis , 4.3%（2/47） achieved complete remission （ CR ） , 66.0%（ 31/47 ） achieved partial remission （ PR ） , 21.3%（ 10/47 ） achieved stable disease （SD） and 8.5%（4/47）was with progressive disease （PD）.Objective response rate （ORR） was 70.2%（33/47）, the disease control rates （DCR） was 91.5%（43/47）.The overall progress free survival （ PFS） of patients was 12.8 months.The median PFS of the first line group and the second line or above was 12.8 months and 11.6 months, respectively （χ2 =0.004, P=0.947）.The median PFS of patients with and without brain metastases before crizotinib treatment were 11.63 months and 13.6 months （χ2 =0.023, P =0.881 ）.Grade Ⅰ -Ⅱ adverse reactions occurred in 39 patients; gastrointestinal reactions were most frequent adverse effects , including nausea and vomiting （ 40.4%, 19/47 ） , diarrhea （19.1%, 9/47 ）, followed by visual disturbance （ 42.6%, 20/47 ）.Ⅲ -Ⅳ degree of elevated aminotransferase occurred in 6 patients （12.8%） and Ⅲ-Ⅳ degree of bone marrow suppression occurred in 2 patients （4.3%） .Conclusion Crizotinib demonstrates a high response rate and favorable tolerability＆amp;nbsp;profile in treatment of EML4-ALK-positive advanced NSCLC patients as a target therapy; and the first line and the second line or above patients can benefit from it.

关 键 词：癌 非小细胞肺 治疗结果 克唑替尼 间变性淋巴瘤激酶 

分 类 号：R734.2[医药卫生—肿瘤]