Real‐world data on ALK rearrangement test in Chinese advanced non‐small cell lung cancer (RATICAL): a nationwide multicenter retrospective study

作者：Lin Li, Wencai Li, Chunyan Wu, Yanfeng Xi, Lei Guo, Yuan Ji, Lili Jiang, Ji Li, Jing‐Ping Yun, Gang Chen, Yuan Li, Yueping Liu, Dianbin Mu, Yuchen Han, Leina Sun, Qingxin Xia, Xiaodong Teng, Nanying Che, Wei Wu, Xueshan Qiu, Chao Liu, Xiaochu Yan, Daiqiang Li, Zhihong Zhang, Zhe Wang, Yujun Li, Zheng Wang, Lingchuan Guo, Xiu Nie, Jingshu Geng, Jianhua Zhou, Jianming Ying · 发表于：癌症：英文版 · 年份：2024 · DOI：10.1002/cac2.12593 · 被引用次数：11 · 研究领域：Lung Cancer Treatments and Mutations、Lung Cancer Diagnosis and Treatment、Lung Cancer Research Studies

BACKGROUND: Anaplastic lymphoma kinase (ALK) test in advanced non-small cell lung cancer (NSCLC) can help physicians provide target therapies for patients harboring ALK gene rearrangement. This study aimed to investigate the real-world test patterns and positive rates of ALK gene rearrangements in advanced NSCLC. METHODS: In this real-world study (ChiCTR2000030266), patients with advanced NSCLC who underwent an ALK rearrangement test in 30 medical centers in China between October 1, 2018 and December 31, 2019 were retrospectively analyzed. Interpretation training was conducted before the study was initiated. Quality controls were performed at participating centers using immunohistochemistry (IHC)-VENTANA-D5F3. The positive ALK gene rearrangement rate and consistency rate were calculated. The associated clinicopathological characteristics of ALK gene rearrangement were investigated as well. RESULTS: The overall ALK gene rearrangement rate was 6.7% in 23,689 patients with advanced NSCLC and 8.2% in 17,436 patients with advanced lung adenocarcinoma. The quality control analysis of IHC-VENTANA-D5F3 revealed an intra-hospital consistency rate of 98.2% (879/895) and an inter-hospital consistency rate of 99.2% (646/651). IHC-VENTANA-D5F3 was used in 53.6%, real-time polymerase chain reaction (RT-PCR) in 25.4%, next-generation sequencing (NGS) in 18.3%, and fluorescence in-situ hybridization (FISH) in 15.9% in the adenocarcinoma subgroup. For specimens tested with multiple methods, t...