Division of Medical Oncology, University of Colorado Cancer Center, Anschutz Medical Campus, Aurora, Colorado, USA.
Cancer. 2013 Apr 15;119(8):1467-77. doi: 10.1002/cncr.27913. Epub 2012 Dec 20.
In series dominated by adenocarcinoma histology, approximately 5% of non-small cell lung cancers (NSCLCs) harbor an anaplastic lymphoma kinase (ALK) gene rearrangement. Crizotinib, a tyrosine kinase inhibitor with significant activity against ALK, has demonstrated high response rates and prolonged progression-free survival in ALK-positive patients enrolled in phase 1/2 clinical trials. In 2011, crizotinib received accelerated approval from the US Food and Drug Administration (FDA) for the treatment of proven ALK-positive NSCLC using an FDA-approved diagnostic test. Currently, only break-apart fluorescence in situ hybridization testing is FDA approved as a companion diagnostic for crizotinib; however, many other assays are available or in development. In the current review, the authors summarize the diagnostic tests available, or likely to become available, that could be used to identify patients with ALK-positive NSCLC, highlighting the pros and cons of each.
在腺癌组织学占主导地位的系列中，约 5%的非小细胞肺癌（NSCLC）存在间变性淋巴瘤激酶（ALK）基因重排。克唑替尼是一种针对 ALK 具有显著活性的酪氨酸激酶抑制剂，在ALK 阳性患者中进行的 1/2 期临床试验中，显示出高缓解率和延长的无进展生存期。2011 年，克唑替尼获得了美国食品和药物管理局（FDA）的加速批准，用于治疗经 FDA 批准的诊断测试证实的 ALK 阳性 NSCLC。目前，只有分离荧光原位杂交检测被 FDA 批准作为克唑替尼的伴随诊断；然而，还有许多其他检测方法可用或正在开发中。在当前的综述中，作者总结了可用于识别 ALK 阳性 NSCLC 患者的现有或可能出现的诊断检测方法，强调了每种方法的优缺点。
