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This page contains key evidence-based clinical practice guidelines for use in patients with lung cancer.

NEW Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors

Authors: Lindeman N, Cagle P, Aisner D, et al.

This is a modification and expansion of molecular (genetic) testing of lung carcinomas to be treated with tyrosine kinase inhibitors, as recommended by the CAP, IASLC and AMP in 2013. This new version allows testing on cytology specimens (smears and blocks), testing for ROS-1, permits immunohistochemistry rather than FISH for ALK and ROS translocations, and recommends against the use of immunohistochemistry for EGFR mutations.

Systemic Therapy for Stage IV Non–Small-Cell Lung Cancer Update

Authors: N. Hanna, et al.

Objective: To establish evidence-based recommendations for the molecular analysis of lung cancers that are that are required to guide EGFR- and ALK-directed therapies, addressing which patients and samples should be tested, and when and how testing should be performed.

 Participants: Three cochairs without conflicts of interest were selected, one from each of the 3 sponsoring professional societies: College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Writing and advisory panels were constituted from additional experts from these societies.

 Evidence: Three unbiased literature searches of electronic databases were performed to capture articles published published from January 2004 through February 2012, yielding 1533 articles whose abstracts were screened to identify 521 pertinent articles that were then reviewed in detail for their relevance to the recommendations. Evidence was formally graded for each recommendation."

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 IASLC Atlas of PD-L1 Immunohistochemistry Testing in Lung Cancer:

"Despite very encouraging progress in the development and use of immunotherapy for patients with non-small cell lung cancer, much confusion remains regarding patient selection for each therapy. Programmed cell death ligand-1 (PD-L1) protein expression, as detected by immunohistochemistry (IHC) testing, has been widely used as a predictive biomarker assay for anti–PD-1/PD-L1 therapies. In fact, an assay for determination of PD-L1 expression is approved by the US Food and Drug Administration for both first-line and second-line therapy with pembrolizumab. There is no clear understanding among physicians, health care personnel, or patients, however, regarding which assay to use for PD-L1 testing and whether the various assays are interchangeable because each assay was co-developed with a therapy. This complex biomarker scenario—the likes of which we have not faced before in lung cancer diagnostics—poses many challenges for pathologists, oncologists, and patients. The International Association for the Study of Lung Cancer (IASLC) has recognized the importance and timeliness of this topic and has convened an expert panel of authors to present current information about the emerging PD-L1 IHC assays, as well as to highlight both areas of clarity and debate." 


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