Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors-Updated Molecular Testing Guideline

Updated Molecular Testing Guideline - FAQs

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The College of American Pathologists, International Association for the Study of Lung Cancer, and the Association for Molecular Pathology have released an updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors (TKIs). The guideline provides recommendations based on the strength of the available data and aims to guide physicians in clinical decision-making.<br /><br />The guideline recommends molecular testing of tumors at diagnosis for patients with early stage disease, and for those with advanced stage disease, including stage IIIB or IV lung cancer. The guideline also recommends the use of next generation sequencing (NGS) panels for molecular testing, as they can detect a wide range of genetic alterations. In cases where tissue-based testing is not feasible, a cell-free DNA assay can be used as an alternative.<br /><br />The guideline strongly recommends testing for EGFR and ALK mutations in all lung adenocarcinoma patients, as well as ROS1 testing for advanced stage adenocarcinoma patients. BRAF, RET, ERBB2, MET, and KRAS testing are not currently indicated as routine stand-alone tests, but can be included in larger testing panels if EGFR, ALK, and ROS1 testing are negative.<br /><br />The guideline also provides recommendations for testing in patients who have progressed or relapsed on targeted therapy, including the use of re-biopsy or plasma cell-free DNA analysis to identify specific mutations.<br /><br />Immunohistochemistry is recommended as an alternative to fluorescent in situ hybridization (FISH) for ALK testing, while ROS1 immunohistochemistry may be used as a screening test, but positive results should be confirmed by molecular or cytogenetic methods.<br /><br />The guideline does not address testing for immunomodulatory therapies, but recommends preserving samples for future assessment of biomarkers that predict response to these therapies.<br /><br />Following the guideline is not mandatory, but laboratories are encouraged to adopt the recommendations. The organizations anticipate the need for future updates as technology, scientific understanding, and clinical practice evolve.

Keywords

molecular testing

lung cancer

tyrosine kinase inhibitors

guideline

physicians

next generation sequencing

EGFR mutations

ALK mutations

ROS1 testing

immunohistochemistry