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Abstract：
Lung cancer is the most commonly diagnosed malignancy and the leading cause of death from cancer globally. Diagnosis of advanced non-small cell lung cancer (NSCLC) is associated with 5-year relative survival of 3.2%. ROS proto-oncogene 1 (ROS1) is an oncogenic driver of NSCLC occurring in up to 2% of cases and commonly associated with younger age and a history of never or light smoking. Results of an early trial with the tyrosine kinase inhibitor (TKI) crizotinib that inhibits tumours that harbour ROS1 rearrangements have shown an objective response rate (ORR) of 72% (95% CI 58-83%), median progression free survival (PFS) of 19.3 months (95% CI 15.2-39.1 months) and median overall survival (OS) of 51.4 months (95% CI 29.3 months to not reached). Therefore, with the availability of highly effective ROS1-targeted TKI therapy, upfront molecular testing for ROS1 status alongside EGFR and ALK testing is recommended for all patients with NSCLC. We review the tissue requirements for ROS1 testing by immunohistochemistry (IHC) and fluorescent in situ hybridisation (FISH) and we present a testing algorithm for advanced NSCLC and consider how the future of pathology testing for ROS1 may evolve.
摘要：
肺癌是全球最常见的恶性肿瘤，也是癌症死亡的主要原因。晚期非小细胞肺癌(NSCLC)的诊断与3.2%的5年相对生存率相关。ROS原癌基因1（ROS1）是NSCLC的致癌驱动因素，发生在多达2％的病例中，通常与年龄较小和从不吸烟或吸烟的历史有关。酪氨酸激酶抑制剂（TKI）克唑替尼抑制具有ROS1重排的肿瘤的早期试验结果显示，客观缓解率（ORR）为72％（95％CI58-83％），中位无进展生存期(PFS)为19.3个月(95%CI15.2~39.1个月),中位总生存期(OS)为51.4个月(95%CI29.3个月未达到).因此,随着高效ROS1靶向TKI治疗的可用性，建议对所有NSCLC患者进行前期的ROS1状态分子检测以及EGFR和ALK检测.我们回顾了通过免疫组织化学（IHC）和荧光原位杂交（FISH）进行ROS1测试的组织要求，并提出了一种用于晚期NSCLC的测试算法，并考虑了ROS1病理学测试的未来可能会如何发展。
