Selective Molecular Testing Recommended for Lung Cancer Patients
By Will Boggs MD
NEW YORK (Reuters Health) – The American Society of Clinical Oncology (ASCO) has endorsed, with minor modifications, other professional societies’ molecular guidelines on selecting patients with lung cancer for treatment with targeted tyrosine kinase inhibitors (TKIs). Those guidelines come from the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP).
"All patients with advanced lung adenocarcinoma should undergo appropriate molecular diagnostic testing that should include, at a minimum, evaluation for driver mutations in EGFR, ALK, ROS1, and BRAF,” Dr. Gregory P. Kalemkerian from the University of Michigan, Ann Arbor, told Reuters Health by email.
Treatment with targeted TKI therapy can improve outcomes for patients with certain molecular alterations that can be identified by molecular testing, prompting CAP/IASLC/AMP to issue nearly two dozen recommendations that guide molecular testing in identifying these patients.
Dr. Kalemkerian and colleagues on the ASCO Expert Panel critically appraised and endorsed the updated CAP/IASLC/AMP guidelines in their February 5 Journal of Clinical Oncology online report.
“Broader multiplexed molecular diagnostic panels are preferred over single-gene testing if they are available,” Dr. Kalemkerian said. “These may detect other driver mutations which may suggest alternative treatment options (MET, RET, HER2) or allow enrollment (in) clinical trials.”
While supporting virtually all of the updated recommendations, ASCO suggests some modifications and qualifying statements.
ASCO does not endorse the CAP/IASLC/AMP recommendation related to BRAF testing in patients with advanced adenocarcinoma. Since the updated recommendations were issued, FDA has granted approval for stand-alone BRAF testing; therefore, the ASCO panel incorporated this fact into their recommendations and recommend BRAF testing for all patients with advanced lung adenocarcinoma.
The expert panel also notes that “the interpretation and implementation of some of the statements may be influenced by the geographic location and the practice setting (academic versus community). This may particularly be true for the statements that lack robust evidence and are either primarily consensus opinions or for statements that have no recommendation for or against a particular issue.”
The report details the five recommendations from 2013 that were reaffirmed or updated for 2017 and the 18 new 2017 recommendations, along with suggested modifications and qualifying statements, in its "Bottom Line" table.
“Open questions remain about the utility of molecular testing beyond EGFR, ALK, ROS1, and BRAF,” Dr. Kalemkerian said. “These four biomarkers have FDA-approved targeted therapy associated with them, so they are not controversial. Beyond that, there is some clinical evidence that patients with MET, RET, or HER2 mutations may benefit from specifically targeted therapy, but these treatments have not yet been approved in patients with lung cancer. The optimal extent and overall clinical utility of broader molecular testing remain to be fully defined.”
“Molecular diagnostic testing is now part of the standard management of patients with non-small cell lung cancer,” he said. “More attention needs to be paid to obtaining ample biopsy samples and developing efficient mechanisms to get molecular testing done in a timely manner.”
“This is a very rapidly evolving field with a continuous high flow of new data,” Dr. Kalemkerian added. “It is difficult for the practicing oncologist to keep up with advances in many different cancers, which is why it is very important for organizations such as ASCO to support expert guideline panels that can distill the literature down to digestible, clinically relevant highlights.”
JAMA Oncol 2018.
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