Guidelines for clinical practice of ALK fusion detection in non-small-cell lung cancer: a proposal from the Chinese
Wenbin Li1, Jing Zhang1, Zhijie Wang2
1Departments of Pathology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Abstract:
The presence of anaplastic lymphoma kinase (ALK) rearrangement defines a molecular subtype of non-small cell lung cancer (NSCLC). ALK inhibitors (ALKIs) confer significant clinical benefits in patients with ALK-positive advanced NSCLC; therefore, it is of great clinical significance to select accurate, rapid, and appropriate ALK testing methods to screen for patients who are suitable for anti-ALK treatment. In recent years, great progress has been made in the development and clinical application of ALKIs, as well as in our understanding of acquired drug resistance mechanisms. Meanwhile, new ALK companion diagnostic platforms have been developed and applied in clinical practice. Although many studies have shown that there is a high rate of concordance among these platforms, new problems continue to appear during testing. To maximize the benefit for patients, accurate testing results can be obtained by first selecting the appropriate testing method and then formulating, optimizing, and complying with the standardized testing process in accordance with the testing population and specimen types. With the ongoing accumulation of clinical practice data, experience from quality control of ALK testing, and results from multicenter research, an updated expert consensus is necessary. The experts who participated in the discussion and development of this guideline have a rich background in theoretical and clinical testing experience, which ensures the practical value of the information presented in this guideline.
Insights
Accurate anaplastic lymphoma kinase (ALK) testing is crucial for non-small cell lung cancer (NSCLC) patients receiving ALK inhibitors. This guideline emphasizes selecting appropriate methods and standardizing processes for optimal patient benefit.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genetics
Background:
- Anaplastic lymphoma kinase (ALK) rearrangement identifies a key non-small cell lung cancer (NSCLC) subtype.
- ALK inhibitors (ALKIs) offer significant clinical benefits for patients with ALK-positive advanced NSCLC.
- Accurate ALK testing is vital for patient selection for anti-ALK therapy.
Purpose of the Study:
- To provide an updated expert consensus on ALK testing methods for non-small cell lung cancer (NSCLC).
- To guide the selection and standardization of ALK testing processes for clinical practice.
- To address challenges and ensure accuracy in ALK testing amidst evolving diagnostic platforms.
Main Methods:
- Review of recent advancements in ALK inhibitors and resistance mechanisms.
- Evaluation of newly developed ALK companion diagnostic platforms.
- Consensus development based on expert theoretical and clinical testing experience.
Main Results:
- High concordance rates observed among various ALK testing platforms.
- Emerging challenges and complexities in routine ALK testing.
- Importance of selecting appropriate testing methods based on patient population and specimen type.
Conclusions:
- Standardized and optimized ALK testing processes are essential for maximizing patient benefit.
- An updated expert consensus is necessary due to accumulated clinical data and quality control experience.
- This guideline offers practical value for accurate ALK testing in clinical settings.
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