1. Programmed Death Ligand-1 and Tumor Mutation Burden Testing of Patients With Lung Cancer for Selection of Immune Checkpoint Inhibitor Therapies: Guideline From the College of American Pathologists, Association for Molecular Pathology, International Association for the Study of Lung Cancer, Pulmonary Pathology Society, and LUNGevity Foundation
- Author
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Sholl, Lynette M., Awad, Mark, Roy, Upal Basu, Beasley, Mary Beth, Cartun, Richard Walter, Hwang, David M., Kalemkerian, Gregory, Lopez-Rios, Fernando, Mino- Kenudson, Mari, Paintal, Ajit, Reid, Kearin, Ritterhouse, Lauren, Souter, Lesley A., Swanson, Paul E., Ventura, Christina B., and Furtado, Larissa V.
- Subjects
Gene mutations -- Health aspects ,Glycoproteins -- Physiological aspects -- Health aspects ,Immunoassay -- Usage ,Immunotherapy -- Methods -- Physiological aspects ,Lung cancer, Non-small cell -- Drug therapy -- Development and progression -- Prognosis ,Monoclonal antibodies -- Usage -- Physiological aspects ,Biological markers -- Physiological aspects -- Health aspects ,Genetic screening -- Usage ,Health - Abstract
* Context.--Rapid advancements in the understanding and manipulation of tumor-immune interactions have led to the approval of immune therapies for patients with non-small cell lung cancer. Certain immune checkpoint inhibitor therapies require the use of companion diagnostics, but methodologic variability has led to uncertainty around test selection and implementation in practice. Objective.--To develop evidence-based guideline recommendations for the testing of immunotherapy/immunomodulatory biomarkers, including programmed death ligand-1 (PD-L1) and tumor mutation burden (TMB), in patients with lung cancer. Design.--The College of American Pathologists convened a panel of experts in non-small cell lung cancer and biomarker testing to develop evidence-based recommendations in accordance with the standards for trustworthy clinical practice guidelines established by the National Academy of Medicine. A systematic literature review was conducted to address 8 key questions. Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, recommendations were created from the available evidence, certainty of that evidence, and key judgments as defined in the GRADE Evidence to Decision framework. Results.--Six recommendation statements were developed. Conclusions.--This guideline summarizes the current understanding and hurdles associated with the use of PD-L1 expression and TMB testing for immune checkpoint inhibitor therapy selection in patients with advanced non-small cell lung cancer and presents evidence-based recommendations for PD-L1 and tMb testing in the clinical setting. doi: 10.5858/arpa.2023-0536-CP), The advent of immune modulatory therapy has led to a radical shift in the treatment paradigm for patients with a wide range of cancers. The clinical impact of these therapies, [...]
- Published
- 2024
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