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Updated Molecular Testing Guideline for the Select ...
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The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) have updated their molecular testing guideline for the selection of lung cancer patients for targeted tyrosine kinase inhibitor (TKI) treatment. The purpose of this guideline is to provide standards and guidance for molecular analysis of lung cancers to inform treatment decisions based on molecular results. Targeted TKI therapy has shown significant improvement in survival and quality of life for patients with specific molecular alterations in their tumors.<br /><br />The original guideline was published in 2013, and the new update takes into account new evidence and advancements in therapies, biomarkers, and technologies. The update focuses on recommendations in five areas: new genes to be tested for lung cancer, appropriate methods for molecular testing, the suitability of molecular testing for lung cancers without adenocarcinoma component, testing for relapsed patients with targetable mutations, and the role of testing for circulating cell-free DNA.<br /><br />The guideline categorizes biomarkers into three categories: "must test" biomarkers, which are standard-of-care for all patients with advanced lung cancer, "should test" biomarkers, which are used for clinical trials and larger sequencing panels, and "investigational" biomarkers, which are not recommended for routine clinical use.<br /><br />The guideline provides recommendations, expert consensus opinions, and reaffirmed statements based on the available evidence and consensus among the expert panel. Specific recommendations include the use of molecular testing for genetic targets, the use of immunohistochemistry as an alternative to FISH for ALK testing, and the inclusion of specific genes like ROS1, BRAF, and RET in testing panels.<br /><br />The guideline also addresses emerging markers for molecular testing and provides opinions on the use of biomarkers for immunomodulatory therapies, although there is currently a lack of evidence to make specific recommendations in this area. The authors note that a subsequent practice guideline is being planned to provide evidence-based assessment of methods for selecting patients for immunomodulatory therapies.<br /><br />Overall, the updated guideline aims to help physicians and patients make informed decisions regarding molecular testing and targeted therapy for lung cancer.
Keywords
molecular testing guideline
lung cancer patients
targeted tyrosine kinase inhibitor
molecular analysis
treatment decisions
targeted TKI therapy
survival improvement
quality of life
molecular alterations
new genes for lung cancer
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