Evidence map›Paper›PMID 39016057›Full record

ArticleCancer communications (London, England)2024

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

Lin Li, Wencai Li, Chunyan Wu, Yanfeng Xi, Lei Guo, Yuan Ji, Lili Jiang, Ji Li, Jingping Yun, Gang Chen and 22 more

Abstract readMulticenter Study
In one paragraph

Article in Cancer communications (London, England), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Predictive value of primary tumorCancer imaging : the official publication of the International Cancer Imaging Society · 2026
    Article
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  5. Article
  6. Prognostic impact ofTranslational lung cancer research · 2025
    Article
  7. Review
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Lin LiDepartment of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.ORCID 0000-0002-4932-6488
Wencai LiDepartment of Pathology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, P. R. China.
Chunyan WuDepartment of Pathology, Shanghai Pulmonary Hospital, School of Medicine, Tongji University, Shanghai, P. R. China.
Yanfeng XiDepartment of Pathology, Cancer Hospital Affiliated to Shanxi Medical University, Shanxi Province Cancer Hospital, Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences, Taiyuan, Shanxi, P. R. China.
Lei GuoDepartment of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Yuan JiDepartment of Pathology, Zhongshan Hospital, Fudan University, Shanghai, P. R. China.
Lili JiangDepartment of Pathology, West China Hospital of Sichuan University, Chengdu, Sichuan, P. R. China.
Ji LiDepartment of Pathology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.
Jingping YunDepartment of Pathology, Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, P. R. China.
Gang ChenDepartment of Pathology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, Fujian, P. R. China.
Yuan LiDepartment of Pathology, Department of Oncology, Fudan University Cancer Center, Shanghai Medical College of Fudan University, Shanghai, P. R. China.
Yueping LiuDepartment of Pathology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, P. R. China.
Dianbin MuDepartment of Pathology, Shandong Cancer Hospital, Jinan, Shandong, P. R. China.
Yuchen HanDepartment of Pathology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, P. R. China.
Leina SunDepartment of Pathology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, P. R. China.
Qingxin XiaDepartment of Pathology, the Affiliated Cancer Hospital of Zhengzhou University, Henan Provincial Cancer Hospital, Zhengzhou, Henan, P. R. China.
Xiaodong TengDepartment of Pathology, the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.
Nanying CheDepartment of Pathology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, P. R. China.ORCID 0000-0003-4179-1737
Wei WuDepartment of Pathology, Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, Zhejiang, P. R. China.
Xueshan QiuDepartment of Pathology, the First Hospital of China Medical University, Shenyang, Liaoning, P. R. China.ORCID 0000-0001-9481-8249
Chao LiuDepartment of Pathology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, P. R. China.
Xiaochu YanInstitute of Pathology, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, P. R. China.
Daiqiang LiDepartment of Pathology, the Second Xiangya Hospital of Central South University, Changsha, Hunan, P. R. China.
Zhihong ZhangDepartment of Pathology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, P. R. China.ORCID 0000-0002-5779-9365
Zhe WangDepartment of Pathology, Xijing Hospital, Fourth Military Medical University, Xi'an, Shaanxi, P. R. China.
Yujun LiDepartment of Pathology, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, P. R. China.
Zheng WangDepartment of Pathology, Beijing Hospital, National Center of Gerontology, Beijing, P. R. China.
Lingchuan GuoDepartment of Pathology, the First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, P. R. China.
Xiu NieDepartment of Pathology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, P. R. China.
Jingshu GengDepartment of Pathology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, P. R. China.
Jianhua ZhouDepartment of Pathology, Xiangya Hospital, Central South University, Changsha, Hunan, P. R. China.
Jianming YingDepartment of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, P. R. China.

Funding

Beijing Hope Run Special Fund of Cancer Foundation of the People's Republic of China LC2019L04CAMS Innovation Fund for Medical Sciences 2021-1-I2M-012CAMS Innovation Fund for Medical Sciences 2022-I2M-C&T-B-078Capital's Funds for Health Improvement and Research 2020-2Z-4028National Key Research and Development Program 2022YFC2409902
6 · The paper itself

Abstract

backgroundAnaplastic 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.

methodsIn 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.

resultsThe 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).

conclusionsThis 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.

Indexed as

Anaplastic Lymphoma KinaseCarcinoma, Non-Small-Cell LungGene RearrangementLung NeoplasmsAdultAgedAged, 80 and overChinaEast Asian PeopleFemaleHumansImmunohistochemistryMaleMiddle AgedRetrospective StudiesYoung AdultALK protein, humanAnaplastic Lymphoma Kinaseanaplastic lymphoma kinasediagnosisgene fusionnon‐small cell lung cancer

Identifiers

PMID39016057
PMCPMC11492361

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