Guidelines to select patients with lung cancer for EGFR and ALK tyrosine kinase inhibitors are being updated by the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP).
The updated guideline will include new recommendations for ALK testing by IHC, ALK-EGFR resistance, and a number of emerging molecular targets which will include, but is not limited to, ROS1, MET, ERBB2, RET, NTRK1. Multiplexed Next Generation Sequencing multigene panels and the reassessment of immunohistochemistry will be reviewed. The role of rebiopsy and repeat analysis in the setting of posttreatment relapse, along with testing of blood samples for mutations in circulating tumor cells, cell free tumor DNA, or exosomes will be considered.
The revision of the guideline will again be based on evidence from unbiased review of published experimental literature. The revisions will be recommended by an expert panel made up of renowned worldwide leaders in the field. The revision will start in early 2015, taking approximately 18 months to complete.
The three organizations collaborated in 2013 to develop the original version of the guideline, which addressed which patients and samples should be tested and when and how testing should be performed. These were published in Archives of Pathology and Laboratory Medicine (2013;137:828-860).
“Although only 1 year has passed since the molecular testing guideline was published, rapid accumulation of scientific knowledge and new evidence in this field indicate that the guidelines should be updated. Thus, an update has begun that includes an expanded list of genes and new methods that are clinically relevant,” said Yasushi Yatabe, MD, PhD, chief, Department of Pathology and Molecular Diagnostics, Aichi Cancer Center, Nagoya, Japan and IASLC member.
Patients battling lung cancer in the United States and abroad have continued hope with the benefits of these guidelines. Testing for the EGFR mutation and ALK rearrangements and the use of targeted therapies have given lung cancer patients the chance for survival, along with improved quality of life and time with loved ones.
“More than 224,200 new cases of lung cancer were diagnosed in 2014 in the United States,” said Philip T. Cagle, MD, FCAP, medical director of Pulmonary Pathology in the Department of Pathology and Genomic Medicine at The Methodist Hospital in Houston, Texas, Archives of Pathology and Laboratory Medicine editor-in-chief, and CAP member. “Rapid advancements in genetic testing offer new treatment options for patients with advanced lung cancer. The updates to the guideline will help pathologists and oncologists to provide more accurate testing, leading to more optimal patient care.”
In an era of precision medicine, the guideline provides recommendations for pathologists, oncologists, and other cancer health professionals on the current state-of-the-art recommendations for the molecular testing of lung cancer.
In October of 2014, The American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines Committee (CPGC) endorsed the CAP/IASLC/AMP guideline for EGFR and ALK molecular testing. This is significant to the CAP/ IASLC/AMP guidelines because it reinforces the importance of molecular testing. The goal is to give providers and patients the best recommendations to treat their lung cancer.