[Efficacy and Safety of Crizotinib in Advanced or Recurrent â©ALK-positive Non-small Cell Lung Cancer].

: 【中文题目：克唑替尼治疗晚期或复发性ALK阳性
非小细胞肺癌的疗效和安全性】 【中文摘要：背景与目的 间变性淋巴瘤激酶（anaplastic lymphoma kinase, ALK）基因在晚期非小细胞肺癌（non-small cell lung cancer, NSCLC）中的阳性比例约为5%-7%，ALK酪氨酸激酶抑制剂（tyrosine kinase inhibitor, TKI）为ALK阳性NSCLC患者的标准治疗。本研究拟评价克唑替尼在ALK阳性的晚期或复发性NSCLC患者中的疗效和安全性。方法 用三种方法筛选携带ALK基因融合/倒位的晚期或复发NSCLC患者，免疫荧光原位杂交（flourescence in situ hybridization, FISH）显示阳性者给予克唑替尼口服，250 mg，2次/d。评价客观有效率（objective response rate, ORR）、无进展生存期（progression-free survival, PFS）及安全性。结果 共筛选226例患者，其中39例出现ALK融合或倒位，37例入组，35例患者可评价客观疗效，ORR为70.3%，疾病控制率（disease control rate, 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级-2级，62.3%）、视物障碍（1级，21.8%）、体重减轻（1级，31.4%）、肺炎（2级，3.5%）。结论 克唑替尼单药可用于治疗ALK融合/倒位的晚期NSCLC患者，有效率高，耐受性较好。
】 【中文关键词：肺肿瘤；EML4-ALK；克唑替尼】. 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.