Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors-Methodology for Creation of the Guideline and Other Supplemental Materials

Methodology for Creation of the Guideline and Other Supplemental Materials

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The College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology have released updated guidelines for molecular testing in lung cancer patients. The guidelines aim to establish standard testing and guide targeted therapies for personalized care. The panel of experts reviewed the evidence and made recommendations based on the strength of the evidence and the balance of benefits and harms. The guidelines include reaffirmed recommendations from the 2013 guidelines, as well as new recommendations. They cover topics such as testing for genetic targets like ROS1 and BRAF, the use of immunohistochemistry as a screening test, and the use of circulating DNA and circulating tumor cells for diagnosis. The guidelines emphasize the use of validated assays and technical validation experiments to ensure the reliability of testing. They also address the analysis of secondary resistance and predictive biomarkers for clinical outcomes. The guidelines have been reviewed and approved by relevant medical societies and patient advocacy groups.<br /><br />The updated guidelines provide specific recommendations for molecular testing in lung cancer patients. They recommend ROS1 testing for all advanced stage lung adenocarcinoma patients, and suggest using immunohistochemistry as a screening test. The guidelines also recommend multiplexed genetic sequencing panels over single-gene tests to identify treatment options beyond EGFR, ALK, and ROS1. They emphasize the importance of EGFR T790M mutational testing in guiding treatment selection with third-generation EGFR inhibitors. The guidelines suggest using cell-free plasma DNA assays for EGFR testing in situations where tissue availability is limited. They also recommend using cfDNA methods to identify EGFR T790M mutations in patients with acquired resistance to EGFR-targeted tyrosine kinase inhibitors. Overall, the guidelines aim to provide comprehensive recommendations for molecular testing in lung cancer patients, with the goal of guiding treatment decisions based on specific genetic alterations. The recommendations are evidence-based and supported by studies and meta-analyses.

Keywords

molecular testing

lung cancer patients

targeted therapies

genetic targets

immunohistochemistry

circulating DNA

validated assays

EGFR

treatment options

genetic alterations