Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment with Targeted Tyrosine Kinase Inhibitors, Summary of Recommendations-Summary of Recommendations

Summary of Recommendations

Pdf Summary

The updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors provides recommendations on which new genes should be tested, what methods should be used for molecular testing, and the role of testing for circulating cell-free DNA. <br /><br />The guideline recommends that ROS1 testing must be performed on all lung adenocarcinoma patients, regardless of clinical characteristics. ROS1 IHC may be used as a screening test, but positive results should be confirmed by a molecular or cytogenetic method. BRAF, RET, ERBB2 (HER2), KRAS, and MET molecular testing are not recommended as routine stand-alone assays, but can be included as part of larger testing panels performed when routine EGFR, ALK, and ROS1 testing are negative. <br /><br />IHC is an equivalent alternative to FISH for ALK testing, and multiplexed genetic sequencing panels are preferred over single-gene tests for identifying other treatment options beyond EGFR, ALK, and ROS1. Laboratories should ensure that test results of low confidence are confirmed or resolved using an alternative method or sample.<br /><br />Molecular biomarker testing may be used in tumors with histologies other than adenocarcinoma when clinical features indicate a higher probability of an oncogenic driver. EGFR T790M mutational testing is recommended for lung adenocarcinoma patients who have progressed after treatment with an EGFR-targeted TKI, and assays capable of detecting EGFR T790M mutations in as little as 5% of viable cells should be used.<br /><br />The use of circulating cell-free DNA molecular methods for the diagnosis of primary lung adenocarcinoma is not supported, but cfDNA assays may be used to identify EGFR mutations in some clinical settings. cfDNA methods may also be used to identify EGFR T790M mutations in lung adenocarcinoma patients with progression or resistance to EGFR-targeted TKIs.<br /><br />These guidelines aim to provide clinicians with recommendations on molecular testing in lung cancer to guide treatment decisions and improve patient outcomes.

Keywords

molecular testing

lung cancer

targeted tyrosine kinase inhibitors

genes

circulating cell-free DNA

ROS1 testing

IHC

ALK testing

genetic sequencing panels

EGFR T790M mutational testing