Real-world data on ALK rearrangement test in Chinese advanced non-small cell lung cancer (RATICAL): a nationwide multicenter retrospective study
文献类型：期刊论文
| 作者 | Li, Lin2; Li, Wencai1; Wu, Chunyan3; Xi, Yanfeng4; Guo, Lei2; Ji, Yuan5; Jiang, Lili6; Li, Ji7; Yun, Jingping8,9,10; Chen, Gang11 |
| 刊名 | CANCER COMMUNICATIONS
 |
| 出版日期 | 2024-07-17 |
| 关键词 | anaplastic lymphoma kinase diagnosis gene fusion non-small cell lung cancer |
| DOI | 10.1002/cac2.12593 |
| 通讯作者 | Ying, Jianming(jmying@cicams.ac.cn) |
| 英文摘要 | 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, the consistency rates confirmed by IHC-VENTANA-D5F3 were 98.0% (822/839) for FISH, 98.7% (1,222/1,238) for NGS, and 91.3% (146/160) for RT-PCR. The overall ALK gene rearrangement rates were higher in females, patients of <= 35 years old, never smokers, tumor cellularity of > 50, and metastatic specimens used for testing in the total NSCLC population and adenocarcinoma subgroup (all P < 0.05). Conclusions: This study highlights the real-world variability and challenges of ALK test in advanced NSCLC, demonstrating a predominant use of IHC-VENTANA-D5F3 with high consistency and distinct clinicopathological features in ALK-positive patients. These findings underscore the need for a consensus on optimal test practices and support the development of refined ALK test strategies to enhance diagnostic accuracy and therapeutic decision-making in NSCLC. |
| WOS关键词 | GUIDE TARGETED THERAPY ; DRIVER MUTATIONS ; CRIZOTINIB ; NSCLC ; PREVALENCE ; FEATURES ; ASSAY ; FISH |
| 资助项目 | CAMS Innovation Fund for Medical Sciences (CIFMS)[2021-1-I2M-012] ; CAMS Innovation Fund for Medical Sciences (CIFMS)[2022-I2M-CT-B-078] ; Beijing Hope Run Special Fund of Cancer Foundation of the People's Republic of China[LC2019L04] ; National Key Research and Development Program[2022YFC2409902] ; Capital's Funds for Health Improvement and Research[2020-2Z-4028] |
| WOS研究方向 | Oncology |
| 语种 | 英语 |
| WOS记录号 | WOS:001269787500001 |
| 出版者 | WILEY |
| 资助机构 | CAMS Innovation Fund for Medical Sciences (CIFMS) ; Beijing Hope Run Special Fund of Cancer Foundation of the People's Republic of China ; National Key Research and Development Program ; Capital's Funds for Health Improvement and Research |
| 源URL | [http://ir.hfcas.ac.cn:8080/handle/334002/137175]  |
| 专题 | 中国科学院合肥物质科学研究院 |
| 通讯作者 | Ying, Jianming |
| 作者单位 | 1.Zhengzhou Univ, Dept Pathol, Affiliated Hosp 1, Zhengzhou, Henan, Peoples R China 2.Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Natl Canc Ctr,Dept Pathol, Beijing, Peoples R China 3.Tongji Univ, Shanghai Pulm Hosp, Dept Pathol, Sch Med, Shanghai, Peoples R China 4.Shanxi Med Univ, Dept Pathol, Canc Hosp, Shanxi Prov Canc Hosp,Shanxi Hosp,Canc Hosp,Chines, Taiyuan, Shanxi, Peoples R China 5.Fudan Univ, Zhongshan Hosp, Dept Pathol, Shanghai, Peoples R China 6.Sichuan Univ, West China Hosp, Dept Pathol, Chengdu, Sichuan, Peoples R China 7.Chinese Acad Med Sci & Peking Union Med Coll, Peking Union Med Coll Hosp, Dept Pathol, Beijing, Peoples R China 8.Sun Yat Sen Univ, Canc Ctr, Dept Pathol, Guangzhou, Guangdong, Peoples R China 9.State Key Lab Oncol South China, Guangzhou, Guangdong, Peoples R China 10.Collaborat Innovat Ctr Canc Med, Guangzhou, Guangdong, Peoples R China |
| 推荐引用方式 GB/T 7714 | Li, Lin,Li, Wencai,Wu, Chunyan,et al. Real-world data on ALK rearrangement test in Chinese advanced non-small cell lung cancer (RATICAL): a nationwide multicenter retrospective study[J]. CANCER COMMUNICATIONS,2024. |
| APA | Li, Lin.,Li, Wencai.,Wu, Chunyan.,Xi, Yanfeng.,Guo, Lei.,...&Ying, Jianming.(2024).Real-world data on ALK rearrangement test in Chinese advanced non-small cell lung cancer (RATICAL): a nationwide multicenter retrospective study.CANCER COMMUNICATIONS. |
| MLA | Li, Lin,et al."Real-world data on ALK rearrangement test in Chinese advanced non-small cell lung cancer (RATICAL): a nationwide multicenter retrospective study".CANCER COMMUNICATIONS (2024). |
入库方式： OAI收割
来源：合肥物质科学研究院
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