TY - JOUR
T1 - Programmed Death Ligand-1 and Tumor Mutation Burden Testing of Patients With Lung Cancer for Selection of Immune Checkpoint Inhibitor Therapies
AU - Sholl, Lynette M.
AU - Awad, Mark
AU - Roy, Upal Basu
AU - Beasley, Mary Beth
AU - Cartun, Richard Walter
AU - Hwang, David M.
AU - Kalemkerian, Gregory
AU - Lopez-Rios, Fernando
AU - Mino-Kenudson, Mari
AU - Paintal, Ajit
AU - Reid, Kearin
AU - Ritterhouse, Lauren
AU - Souter, Lesley A.
AU - Swanson, Paul E.
AU - Ventura, Christina B.
AU - Furtado, Larissa V.
N1 - Publisher Copyright:
© 2024 College of American Pathologists. All rights reserved.
PY - 2024/7
Y1 - 2024/7
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85197345950&partnerID=8YFLogxK
U2 - 10.5858/arpa.2023-0536-CP
DO - 10.5858/arpa.2023-0536-CP
M3 - Article
C2 - 38625026
AN - SCOPUS:85197345950
SN - 0003-9985
VL - 148
SP - 757
EP - 774
JO - Archives of Pathology and Laboratory Medicine
JF - Archives of Pathology and Laboratory Medicine
IS - 7
ER -