Abstract | CONTEXT.—: 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.
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Authors | Lynette M Sholl, Mark Awad, Upal Basu Roy, Mary Beth Beasley, Richard Walter Cartun, David M Hwang, Gregory Kalemkerian, Fernando Lopez-Rios, Mari Mino-Kenudson, Ajit Paintal, Kearin Reid, Lauren Ritterhouse, Lesley A Souter, Paul E Swanson, Christina B Ventura, Larissa V Furtado |
Journal | Archives of pathology & laboratory medicine
(Arch Pathol Lab Med)
(Apr 16 2024)
ISSN: 1543-2165 [Electronic] United States |
PMID | 38625026
(Publication Type: Journal Article)
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Copyright | © 2024 College of American Pathologists. |