New Guidelines May Help Better Guide Molecular Testing for Lung Cancer

New steps are now being taken to revise molecular testing guidelines in an effort to improve patient selection and optimize the use of targeted therapies in lung cancer patients.

The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) announced June 28, 2016, the open comment period for the revised evidence-based guideline, “Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors.”

The open comment period will close on August 2, 2016, and the three organizations are hoping that this period will provide an opportunity to review the new draft recommendations for several key topics. The initial guideline was jointly published online in April 2013, by Archives of Pathology & Laboratory Medicine, The Journal of Thoracic Oncology, and The Journal of Molecular Diagnostics. Now, revisions are being considered to reflect the latest advancements in molecular testing and to better match patients to appropriate targeted therapies.

“In an era of precision medicine, our collective ability to not only understand but leverage the latest breakthroughs in lung cancer research will enable us to provide more precise targeted treatment options. The revised guideline provides a clear framework based on evidence from recently published clinical literature,” said Philip Cagle, MD, medical director of pulmonary pathology in the Department of Pathology and Genomic Medicine at Houston Methodist Hospital, and the editor-in-chief of Archives of Pathology & Laboratory Medicine, in an IASLC news release.  

The guideline revisions are all based on evidence from an unbiased review of published experimental literature since 2013 and include the recommendations from an expert panel of renowned worldwide leaders in the field. The final recommendations will be approved and jointly published after consideration of the public comments, further panel discussion, and a complete evidence analysis.

Yasushi Yatabe, MD, PhD, who is chief of the Department of Pathology and Molecular Diagnostics at Aichi Cancer Center in Nagoya, Japan, and IASLC member, said it is important that oncologists and pathologists provide feedback during this public comment period to ensure the new draft recommendations are sound, practical, and implementable.

The final manuscript will serve as an update and extension of the 2013 practice guideline, which established evidence-based identification and best practices for molecular biomarker testing for patients diagnosed with non-squamous, non-small cell lung cancer of all stages, according to said Neal Lindeman, MD, who is the director of Molecular Diagnostics Laboratory at Brigham and Women’s Hospital, associate professor of pathology at Harvard Medical School. He said the guideline will continue to be updated as appropriate. In addition, guidelines for other biomarkers associated with lung cancer will be added as more evidence becomes available.

The new draft recommendations address several key issues such as what other genes, previously not addressed, should be tested in lung adenocarcinoma. The recommendations also cover whether immunohistochemistry is reliable for screening for ALK translocations and the types and rates of secondary resistance in patients who are undergoing treatment with targeted tyrosine kinase inhibitors along with other key questions.