The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP)—have updated their 2013 evidence-based guideline for the testing and treatment of patients with tyrosine kinase inhibitors (TKIs). The new guideline reflects the rapid pace of change in clinical practice due to improved testing capabilities and the identification of new actionable biomarkers discovered since the first guideline was released.
"Several factors influenced this update, which builds on the guidance we set forth in 2013," said Neal Lindeman, M.D., director of molecular diagnostics at Brigham and Women's Hospital, associate professor of pathology at Harvard Medical School in Boston, and AMP member. "Clinical practice guidelines must continually assess new evidence as it accumulates and consider new testing technologies as they emerge."
The updated guideline was created by a multidisciplinary panel comprising pathologists, oncologists, pulmonologists, a methodologist, laboratory scientists, and patient representatives appointed by the three organizations. Led by Lindeman, the guideline was created using the Institute of Medicine’s evidence-based methodology.
The guideline strengthens the existing recommendations from 2013 for patients with lung adenocarcinoma, but has added new genes of significance discovered since that publication, among them:
The guideline also suggested that samples should be collected and saved to help predict response to emerging immunotherapies—such as IHC for PD-L1—but made no specific recommendations about methods to predict treatment response. The organizations noted that such guidelines will be the subject of a subsequent update.
The guideline is now available online at the Archives of Pathology & Laboratory Medicine. AMP, IASLC, and CAP have also made available additional materials to help guide molecular pathologists and oncologists in their adoption including a summary of recommendations, a teaching presentation, frequently asked questions, and videos.