克唑替尼治疗晚期或复发性ALK阳性非小细胞肺癌的疗效与安全性
[Efficacy and Safety of Crizotinib in Advanced or Recurrent ALK-positive Non-small Cell Lung Cancer].
作者信息
Li Xiaoyan, Xu Huayan, Gao Fang, Kang Xun, Zhang Juan, Zhao Jing, Lin Yi, Liu Xiaoqing
机构信息
Department of Oncologic Comprehensive Therapy, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China.
Department of Lung Cancer, The Fifth Medical Center, General Hospital of People's Liberation Army, Beijing 100071, China.
出版信息
Zhongguo Fei Ai Za Zhi. 2019 Aug 20;22(8):488-493. doi: 10.3779/j.issn.1009-3419.2019.08.02.
BACKGROUND
Anaplastic lymphoma kinase (ALK) positive in non-small cell lung cancer (NSCLC) was about 5%-7% and ALK tyrosine kinase inhibitor (TKI) was the standard treatment in NSCLC. The aim of this study is to evaluate the efficacy and safety of crizotinib in patients with advanced ALK gene-positive or recurrent NSCLC.
METHODS
Three methods were used to screen patients with advanced or recurrent NSCLC harboring ALK gene fusion/translocation. The patients with ALK positive tested by flourescence in situ hybridization (FISH) was given orally crizotinib, 250 mg, bid. The objective response rate (ORR), progression-free survival (PFS) and safety were evaluated.
RESULTS
A total of 226 patients were screened, 39 of whom had ALK fusion or translocation, and 37 were enrolled in the study. 35 patients were evaluated for objective response, ORR was 70.3%, and disease control rate (DCR) was 94.6%, and median PFS was 11.8 mon. The main adverse reactions were elevated transaminase (Grade 1, 91.7%), elevated transaminases (Grade 2, 23.4%), nausea (Grade 1, 75.6%), anemia (Grade 1-2, 62.3%), visual impairment (Grade 1, 21.8%), weight loss (Grade 1, 31.4%), pneumonia (Grade 2, 3.5%).
CONCLUSIONS
Crizotinib can be used for the treatment of advanced NSCLC with ALK fusion/translocation. It is highly effective and well tolerated.
背景
间变性淋巴瘤激酶（ALK）阳性的非小细胞肺癌（NSCLC）约占5%-7%，ALK酪氨酸激酶抑制剂（TKI）是NSCLC的标准治疗方法。本研究的目的是评估克唑替尼在晚期ALK基因阳性或复发性NSCLC患者中的疗效和安全性。
方法
采用三种方法筛选携带ALK基因融合/易位的晚期或复发性NSCLC患者。荧光原位杂交（FISH）检测ALK阳性的患者口服克唑替尼，250mg，每日两次。评估客观缓解率（ORR）、无进展生存期（PFS）和安全性。
结果
共筛选226例患者，其中39例有ALK融合或易位，37例纳入研究。35例患者接受客观缓解评估，ORR为70.3%，疾病控制率（DCR）为94.6%，中位PFS为11.8个月。主要不良反应为转氨酶升高（1级，91.7%）、转氨酶升高（2级，23.4%）、恶心（1级，75.6%）、贫血（1-2级，62.3%）、视力障碍（1级，21.8%）、体重减轻（1级，31.4%）、肺炎（2级，3.5%）。
结论
克唑替尼可用于治疗具有ALK融合/易位的晚期NSCLC。它具有高效性且耐受性良好。
Zotero 插件