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

IF 20.1 1区医学 Q1 ONCOLOGY Cancer Communications Pub Date : 2024-07-17 DOI:10.1002/cac2.12593

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

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Abstract

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.

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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。

背景：晚期非小细胞肺癌（NSCLC）中的无性淋巴瘤激酶（ALK）检测可帮助医生为携带ALK基因重排的患者提供靶向治疗。本研究旨在调查真实世界中晚期非小细胞肺癌 ALK 基因重排的检测模式和阳性率：在这项真实世界研究（ChiCTR2000030266）中，对2018年10月1日至2019年12月31日期间在中国30家医疗中心接受ALK基因重排检测的晚期NSCLC患者进行了回顾性分析。研究开始前进行了解读培训。参与中心使用免疫组化（IHC）-VENTANA-D5F3进行了质量控制。计算了ALK基因重排阳性率和一致性率。同时还调查了与ALK基因重排相关的临床病理特征：23689例晚期NSCLC患者的ALK基因重排率为6.7%，17436例晚期肺腺癌患者的ALK基因重排率为8.2%。IHC-VENTANA-D5F3的质控分析显示，医院内一致性率为98.2%（879/895），医院间一致性率为99.2%（646/651）。腺癌亚组中使用 IHC-VENTANA-D5F3 的占 53.6%，使用实时聚合酶链反应 (RT-PCR) 的占 25.4%，使用新一代测序 (NGS) 的占 18.3%，使用荧光原位杂交 (FISH) 的占 15.9%。对于采用多种方法检测的标本，经 IHC-VENTANA-D5F3 确认的一致性率分别为：FISH 98.0%（822/839），NGS 98.7%（1,222/1,238），RT-PCR 91.3%（146/160）。在所有NSCLC人群和腺癌亚组中，女性、年龄小于35岁、从不吸烟、肿瘤细胞度大于50、用于检测的转移标本的ALK基因重排率较高（均P<0.05）：本研究强调了ALK检测在晚期NSCLC中的现实世界中的可变性和挑战，表明在ALK阳性患者中主要使用IHC-VENTANA-D5F3，一致性高，临床病理特征明显。这些发现强调了就最佳检测方法达成共识的必要性，并支持开发完善的ALK检测策略，以提高NSCLC的诊断准确性和治疗决策。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Communications Biochemistry, Genetics and Molecular Biology-Cancer Research

CiteScore

25.50

自引率

4.30%

发文量

153

审稿时长

4 weeks

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.