Lin Li, Wencai Li, Chunyan Wu, Yanfeng Xi, Lei Guo, Yuan Ji, Lili Jiang, Ji Li, Jingping 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
{"title":"中国晚期非小细胞肺癌ALK重排检测的真实世界数据(RATICAL):一项全国多中心回顾性研究。","authors":"Lin Li, Wencai Li, Chunyan Wu, Yanfeng Xi, Lei Guo, Yuan Ji, Lili Jiang, Ji Li, Jingping 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","doi":"10.1002/cac2.12593","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <p>Anaplastic lymphoma kinase (<i>ALK</i>) test in advanced non-small cell lung cancer (NSCLC) can help physicians provide target therapies for patients harboring <i>ALK</i> gene rearrangement. This study aimed to investigate the real-world test patterns and positive rates of <i>ALK</i> gene rearrangements in advanced NSCLC.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>In this real-world study (ChiCTR2000030266), patients with advanced NSCLC who underwent an <i>ALK</i> 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 <i>ALK</i> gene rearrangement rate and consistency rate were calculated. The associated clinicopathological characteristics of <i>ALK</i> gene rearrangement were investigated as well.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>The overall <i>ALK</i> 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 <i>ALK</i> 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 <i>P</i> < 0.05).</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>This study highlights the real-world variability and challenges of <i>ALK</i> test in advanced NSCLC, demonstrating a predominant use of IHC-VENTANA-D5F3 with high consistency and distinct clinicopathological features in <i>ALK</i>-positive patients. These findings underscore the need for a consensus on optimal test practices and support the development of refined <i>ALK</i> test strategies to enhance diagnostic accuracy and therapeutic decision-making in NSCLC.</p>\n </section>\n </div>","PeriodicalId":9495,"journal":{"name":"Cancer Communications","volume":"44 9","pages":"992-1004"},"PeriodicalIF":20.1000,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cac2.12593","citationCount":"0","resultStr":"{\"title\":\"Real-world data on ALK rearrangement test in Chinese advanced non-small cell lung cancer (RATICAL): a nationwide multicenter retrospective study\",\"authors\":\"Lin Li, Wencai Li, Chunyan Wu, Yanfeng Xi, Lei Guo, Yuan Ji, Lili Jiang, Ji Li, Jingping 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\",\"doi\":\"10.1002/cac2.12593\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <p>Anaplastic lymphoma kinase (<i>ALK</i>) test in advanced non-small cell lung cancer (NSCLC) can help physicians provide target therapies for patients harboring <i>ALK</i> gene rearrangement. This study aimed to investigate the real-world test patterns and positive rates of <i>ALK</i> gene rearrangements in advanced NSCLC.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>In this real-world study (ChiCTR2000030266), patients with advanced NSCLC who underwent an <i>ALK</i> 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 <i>ALK</i> gene rearrangement rate and consistency rate were calculated. The associated clinicopathological characteristics of <i>ALK</i> gene rearrangement were investigated as well.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>The overall <i>ALK</i> 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 <i>ALK</i> 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 <i>P</i> < 0.05).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>This study highlights the real-world variability and challenges of <i>ALK</i> test in advanced NSCLC, demonstrating a predominant use of IHC-VENTANA-D5F3 with high consistency and distinct clinicopathological features in <i>ALK</i>-positive patients. These findings underscore the need for a consensus on optimal test practices and support the development of refined <i>ALK</i> test strategies to enhance diagnostic accuracy and therapeutic decision-making in NSCLC.</p>\\n </section>\\n </div>\",\"PeriodicalId\":9495,\"journal\":{\"name\":\"Cancer Communications\",\"volume\":\"44 9\",\"pages\":\"992-1004\"},\"PeriodicalIF\":20.1000,\"publicationDate\":\"2024-07-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/cac2.12593\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Cancer Communications\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/cac2.12593\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Cancer Communications","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/cac2.12593","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Real-world data on ALK rearrangement test in Chinese advanced non-small cell lung cancer (RATICAL): a nationwide multicenter retrospective study
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.
期刊介绍:
Cancer Communications is an open access, peer-reviewed online journal that encompasses basic, clinical, and translational cancer research. The journal welcomes submissions concerning clinical trials, epidemiology, molecular and cellular biology, and genetics.