Molecular Testing for Selection of Patients With Lung Cancer for Epidermal Growth Factor Receptor and Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Guideline

Leighl, Natasha B.; Rekhtman, Natasha; Biermann, William A.; Huang, James; Mino‐Kenudson, Mari; Ramalingam, Suresh S.; West, Howard; Whitlock, Sara; Somerfield, Mark R.

doi:10.1200/jco.2014.57.3055

Cited by 250 publications

(180 citation statements)

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“…The IASLC approval process required review and approval by the IASLC Board of Directors. The AMP approval process required content review by an independent subject matter expert panel, led by the Publications & Communications chair, with 4 our opinion remains that each institution should set its own policy regarding testing patients with early-stage disease, balancing the benefit of having results on record from testing a high-quality resection sample for alterations that are likely to become necessary at a time of future progression when a high-quality sample could be hard to obtain against the cost of testing patients for whom a subset will be surgically cured and never need the test result. Accordingly, the testing recommended below applies to patients with advanced-stage (stages IIIB and IV) lung cancer.…”

Section: Resultsmentioning

confidence: 99%

“…In 2013, this working group published an evidence-based guideline 1e3 for standard-of-care clinical practice concerning which lung cancer patients and samples should be tested, which genes should be tested, and how these tests should be designed, validated, and executed. This guideline was subsequently endorsed by the American Society of Clinical Oncology, 4 and has been cited in guidelines developed by numerous professional societies around the world. 5e26 However, the field has continued to advance rapidly, with the emergence of new genetic discoveries, new therapies, and new technologies, such that these same 3 organizations convened a second working group to systematically assess new evidence and to issue an evidence-based revision of the lung cancer molecular pathology practice guideline.…”

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confidence: 99%

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Analytical Validation of BRAF Mutation Testing from Circulating Free DNA Using the Amplification Refractory Mutation Testing System

Aung

Donald

Ellison

et al. 2014

The Journal of Molecular Diagnostics

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Context: In 2013, an evidence-based guideline was published by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology to set standards for the molecular analysis of lung cancers to guide treatment decisions with targeted inhibitors. New evidence has prompted an evaluation of additional laboratory technologies, targetable genes, patient populations, and tumor types for testing. Objective: To systematically review and update the 2013 guideline to affirm its validity; to assess the evidence of new genetic discoveries, technologies, and therapies; and to issue an evidence-based update. Design: The College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology convened an expert panel to develop an evidence-based guideline to help define the key questions and literature search terms, review abstracts and full articles, and draft recommendations. Results: Eighteen new recommendations were drafted. The panel also updated 3 recommendations from the 2013 guideline. Conclusions: The 2013 guideline was largely reaffirmed with updated recommendations to allow testing of cytology samples, require improved assay sensitivity, and recommend against the use of

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Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

Analytical Validation of BRAF Mutation Testing from Circulating Free DNA Using the Amplification Refractory Mutation Testing System

Aung

Donald

Ellison

et al. 2014

The Journal of Molecular Diagnostics

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“…Laboratory Improvement Amendments (CLIA) certified laboratory, following CLSI EP7-A2 and published guidelines (30,31). The analytical validation was designed to address precision (repeatability and reproducibility), sensitivity (limit of detection), specificity, and the effect of interfering substances.…”

Section: Analytical and Clinical Validation Of The Test Was Performedmentioning

confidence: 99%

Exosome-Based Detection of EGFR T790M in Plasma from Non–Small Cell Lung Cancer Patients

Castellanos-Rizaldos

Grimm

Tadigotla

et al. 2018

Clinical Cancer Research

173

129

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Tumor tissue biopsies carry risks and are not always possible, making liquid biopsies an attractive way to acquire molecular information from cancer patients. The EGFR T790M mutation is a critical biomarker in non-small cell lung cancer and has introduced new challenges in how these patients are managed. With the approval of osimertinib for patients failing first generation EGFR inhibitor therapy, the use of a liquid biopsy to detect EGFR T790M would reduce the number of unnecessary repeat biopsies. Detection of EGFR T790M using cfDNA has proved to be challenging due to low abundance in blood. Here we present a novel EGFR T790M assay based on a platform validated in a CLIA laboratory that simultaneously monitors the mutation on exosomal RNA/DNA and cfDNA from plasma that achieves 92% sensitivity and 89% specificity.Research. AbstractPurpose: About 60% of non-small cell lung cancer (NSCLC) patients develop resistance to targeted epidermal growth factor receptor (EGFR) inhibitor therapy through the EGFR T790M mutation. Patients with this mutation respond well to third generation tyrosine kinase inhibitors, but obtaining a tissue biopsy to confirm the mutation poses risks and is often not feasible. Liquid biopsies using circulating free tumor DNA (cfDNA) have emerged as a non-invasive option to detect the mutation, however sensitivity is low as many patients have too few detectable copies in circulation. Here we have developed and validated a novel test that overcomes the limited abundance of the mutation by simultaneously capturing and interrogating exosomal RNA/DNA and cfDNA (exoNA) in a single step followed by a sensitive allele specific qPCR.Experimental design: ExoNA was extracted from the plasma of NSCLC patients with biopsy-confirmed T790M-positive (N = 102) and T790M-negative (N = 108) samples.The T790M mutation status was determined using an analytically validated allelespecific qPCR assay in a CLIA laboratory.Results: Detection of the T790M mutation on exoNA achieved 92% sensitivity and 89% specificity using tumor biopsy results as gold standard. We also obtained high sensitivity (88%) in patients with intrathoracic disease (M0/M1a), for whom detection by liquid biopsy has been particularly challenging.Research.on March 26,

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“…However, the current system of biomarker testing practice poses significant challenges: more than half of all responding specialists reported that fewer than 25% of test results are provided in time for firstline treatment decisions. An American Society of Clinical Oncology review panel recently endorsed the guidelines for molecular testing published by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology, which recommended testing for EGFR mutations and ALK fusions in all patients with advanced-stage adenocarcinoma to guide patient selection for targeted therapies 15 . That endorsement highlighted the clinical importance of early molecular diagnosis in determining appropriate treatment plans for patients with advanced lung cancer.…”

Section: Discussionmentioning

confidence: 99%