Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Six recommendation statements were developed.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Six recommendation statements were developed.
UNASSIGNED: 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.
摘要：
■对肿瘤-免疫相互作用的理解和操作的快速发展导致了对非小细胞肺癌患者的免疫疗法的批准。某些免疫检查点抑制剂治疗需要使用伴随诊断，但是方法的可变性导致了在实践中测试选择和实施的不确定性。
■为了制定免疫疗法/免疫调节生物标志物检测的循证指南建议，包括程序性死亡配体-1（PD-L1）和肿瘤突变负荷（TMB），肺癌患者。
■美国病理学家学会召集了一个非小细胞肺癌和生物标志物检测专家小组，根据美国国家医学科学院建立的值得信赖的临床实践指南标准，制定基于证据的建议。进行了系统的文献综述，以解决8个关键问题。使用建议评估的等级，发展,和评估(等级)方法，建议是从现有证据中创建的，证据的确定性，以及“从等级证据到决策框架”中定义的关键判断。
■制定了六项建议声明。
■本指南总结了在晚期非小细胞肺癌患者中使用PD-L1表达和TMB测试进行免疫检查点抑制剂治疗选择的当前理解和障碍，并提出了在临床环境中进行PD-L1和TMB测试的循证建议。
■为了制定免疫疗法/免疫调节生物标志物检测的循证指南建议，包括程序性死亡配体-1（PD-L1）和肿瘤突变负荷（TMB），肺癌患者。
■美国病理学家学会召集了一个非小细胞肺癌和生物标志物检测专家小组，根据美国国家医学科学院建立的值得信赖的临床实践指南标准，制定基于证据的建议。进行了系统的文献综述，以解决8个关键问题。使用建议评估的等级，发展,和评估(等级)方法，建议是从现有证据中创建的，证据的确定性，以及“从等级证据到决策框架”中定义的关键判断。
■制定了六项建议声明。
■本指南总结了在晚期非小细胞肺癌患者中使用PD-L1表达和TMB测试进行免疫检查点抑制剂治疗选择的当前理解和障碍，并提出了在临床环境中进行PD-L1和TMB测试的循证建议。
