After a decade of developing molecular diagnostics for lung cancer, 3 organizations have issued the first guidelines for testing for the EGFR mutation and ALK rearrangement in patients with lung cancer, the number one cancer-related killer worldwide, providing a valuable new tool to fully utilize the benefits of targeted therapies for this patient population.
The guidelines have been developed by the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology. The guidelines, titled “Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors,” establish the first recommendations for the use of EGFR and ALK testing to guide targeted therapies in patients with lung cancer.
“The key recommendation of the guideline, and perhaps most important to lung cancer patients, is that all patients with advanced lung adenocarcinoma should be tested for EGFR and ALK abnormalities, that would qualify them for tyrosine kinase inhibitor therapy, regardless of their clinical variables, such as smoking history, gender, or ethnicity,” said Marc Ladanyi, MD, of the Molecular Diagnostics Service at Memorial Sloan-Kettering Cancer Center in New York, and an IASLC member.
The guidelines highlight the role of personalized medicine for this patient population and provide answers to clinical questions, such as who should be tested, when, and what genes should be tested routinely in patients with lung cancer.
Up to 20% of patients with lung cancer “will test positive for one of the two biomarkers,” said Philip T. Cagle, MD, FCAP, Medical Director of Pulmonary Pathology, Department of Pathology and Genomic Medicine, The Methodist Hospital, Houston, TX, and a CAP member. “It is critical to identify these patients because they stand to benefit more from new targeted drugs than from conventional chemotherapy, and with fewer side effects.”
According to Dr Ladanyi, “The guideline is an important step in making sure that patients benefit from the new molecular understanding of lung cancer.” The guidelines were published on April 3, 2013. International Association for the Study of Lung Cancer Press Release; April 8, 2013
