Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors Neal I. Lindeman,

Slides:

Advertisements

Similar presentations

Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors Neal I. Lindeman, Philip T. Cagle, Mary Beth.

Advertisements

EGFR Mutations in Lung Adenocarcinomas

Epidermal Growth Factor Receptor-Related Tumor Markers and Clinical Outcomes with Erlotinib in Non-small Cell Lung Cancer: An Analysis of Patients from.

Droplet Digital PCR for Absolute Quantification of EML4-ALK Gene Rearrangement in Lung Adenocarcinoma Qiushi Wang, Xin Yang, Yong He, Qiang Ma, Li Lin,

ALK Protein Analysis by IHC Staining after Recent Regulatory Changes: A Comparison of Two Widely Used Approaches, Revision of the Literature, and a New.

Quantitative Analysis of Circulating Cell-Free DNA for Correlation with Lung Cancer Survival: A Systematic Review and Meta-Analysis Sarah Cargnin, PhD,

Real-Time Polymerase Chain Reaction for Detecting Bacterial DNA Directly from Blood of Neonates Being Evaluated for Sepsis Jeanne A. Jordan, Mary Beth.

Adrian G. Sacher, MD, Kimberly M. Komatsubara, MD, Geoffrey R

Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors Neal I. Lindeman, Philip T. Cagle, Mary.

T790M EGFR Mutation Detection in Cerebrospinal Fluid and Response to Osimertinib in a Lung Cancer Patient with Meningeal Carcinomatosis Hugo Gortais,

Next-Generation Sequencing Identifies and Immunohistochemistry Confirms a Novel Crizotinib-Sensitive ALK Rearrangement in a Patient with Metastatic Non–Small-Cell.

Multiplex Preamplification of Serum DNA to Facilitate Reliable Detection of Extremely Rare Cancer Mutations in Circulating DNA by Digital PCR Jennifer.

ALK FISH and IHC: You Cannot Have One without the Other

EGFR and HER2 Genomic Gain in Recurrent Non-small Cell Lung Cancer After Surgery: Impact on Outcome to Treatment with Gefitinib and Association with EGFR.

Detection of EGFR Mutation Status in Lung Adenocarcinoma Specimens with Different Proportions of Tumor Cells Using Two Methods of Differential Sensitivity

Jessica J. Lin, MD, Lauren L. Ritterhouse, MD, PhD, Siraj M

Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors Neal I. Lindeman,

Clinicopathologic Analysis of ROS1-Rearranged Non–Small-Cell Lung Cancer and Proposal of a Diagnostic Algorithm Heounjeong Go, MD, PhD, Dong-Wan Kim,

A Sensitive ALK Immunohistochemistry Companion Diagnostic Test Identifies Patients Eligible for Treatment with Crizotinib Trish Thorne-Nuzzo, BS, Crystal.

Acquired BRAF V600E Mutation as Resistant Mechanism after Treatment with Third- Generation EGFR Tyrosine Kinase Inhibitor Alessandra Bearz, MD, Elisa.

T790M EGFR Mutation Detection in Cerebrospinal Fluid and Response to Osimertinib in a Lung Cancer Patient with Meningeal Carcinomatosis Hugo Gortais,

The Use of Systemic Treatment in the Maintenance of Patients with Non–Small Cell Lung Cancer: A Systematic Review Swati Kulkarni, MD, Emily T. Vella,

Assessment of EGFR Mutation Status in Lung Adenocarcinoma by Immunohistochemistry Using Antibodies Specific to the Two Major Forms of Mutant EGFR Marie.

Pooled Analysis of the Prognostic and Predictive Value of KRAS Mutation Status and Mutation Subtype in Patients with Non–Small Cell Lung Cancer Treated.

Bob T. Li, M. B. B. S. , MPH, Dara S. Ross, MD, Dara L

The International Association for the Study of Lung Cancer Consensus Statement on Optimizing Management of EGFR Mutation–Positive Non–Small Cell Lung.

William L. Gerald, M.D., Ph.D, 1954–2008

Real-Time Polymerase Chain Reaction for Detecting Bacterial DNA Directly from Blood of Neonates Being Evaluated for Sepsis Jeanne A. Jordan, Mary Beth.

How I Do It—Optimal Methodology for Multidirectional Analysis of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration Samples Takahiro Nakajima,

Interpretation of Anti-ALK Immunohistochemistry Results

Keith M. Kerr, MBChB, FRCPath, Ming-Sound Tsao, MD, PhD, Andrew G

Comprehensive Hybrid Capture–Based Next-Generation Sequencing Identifies a Double ALK Gene Fusion in a Patient Previously Identified to Be False-Negative.

Combined Use of ALK Immunohistochemistry and FISH for Optimal Detection of ALK- Rearranged Lung Adenocarcinomas Lynette M. Sholl, MD, Stanislawa Weremowicz,

Tumor Cell Content for Selection of Molecular Techniques for T790M EGFR Mutation Detection in Non-small Cell Lung Cancer Nathalie Prim, Elisabeth Quoix,

A Sensitive ALK Immunohistochemistry Companion Diagnostic Test Identifies Patients Eligible for Treatment with Crizotinib Trish Thorne-Nuzzo, BS, Crystal.

Phase II Trial of Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab Followed by Cetuximab and Bevacizumab in Advanced Nonsquamous Non–Small-Cell Lung.

Reproducibility of Histopathological Diagnosis in Poorly Differentiated NSCLC: An International Multiobserver Study Erik Thunnissen, MD, PhD, Masayuki.

Reliability Assurance of Detection of EML4-ALK Rearrangement in Non–Small Cell Lung Cancer: The Results of Proficiency Testing in China Yulong Li, MD,

Highly Sensitive Droplet Digital PCR Method for Detection of EGFR-Activating Mutations in Plasma Cell–Free DNA from Patients with Advanced Non–Small Cell.

Detection of Human Polyomavirus 7 in Human Thymic Epithelial Tumors

Effusion Immunocytochemistry as an Alternative Approach for the Selection of First-Line Targeted Therapy in Advanced Lung Adenocarcinoma Tzu-Hsiu Tsai,

EGFR Mutations in Lung Adenocarcinomas

A Rapid, Sensitive Assay to Detect EGFR Mutation in Small Biopsy Specimens from Lung Cancer Yasushi Yatabe, Toyoaki Hida, Yoshitsugu Horio, Takayuki.

Comparison of Four PD-L1 Immunohistochemical Assays in Lung Cancer

CtDNA Determination of EGFR Mutation Status in European and Japanese Patients with Advanced NSCLC: The ASSESS Study Martin Reck, MD, PhD, Koichi Hagiwara,

Comprehensive Analysis of the Discordance of EGFR Mutation Status between Tumor Tissues and Matched Circulating Tumor DNA in Advanced Non–Small Cell Lung.

Coexistence of Tyrosine Kinase Inhibitor-Sensitizing and Resistant EGFR Mutations in an Untreated Lung Adenocarcinoma Patient and Response to Erlotinib

Successful Treatment with Gefitinib in Advanced Non–Small Cell Lung Cancer after Acquired Resistance to Osimertinib Nuria Chic, MD Journal of Thoracic.

Erratum Journal of Thoracic Oncology

Icotinib in Patients with Pretreated Advanced Esophageal Squamous Cell Carcinoma with EGFR Overexpression or EGFR Gene Amplification: A Single-Arm, Multicenter.

Arnaud Uguen, MD, PhD Journal of Thoracic Oncology

EGFR Mutations Detected in Plasma Are Associated with Patient Outcomes in Erlotinib Plus Docetaxel-Treated Non-small Cell Lung Cancer Philip C. Mack,

Expanded Circulating Tumor Cells from a Patient with ALK-Positive Lung Cancer Present with EML4-ALK Rearrangement Along with Resistance Mutation and Enable.

Lung Adenocarcinoma with Concurrent Exon 19 EGFR Mutation and ALK Rearrangement Responding to Erlotinib Sanjay Popat, MRCP, PhD, Alexandra Vieira de.

Rapid Polymerase Chain Reaction-Based Detection of Epidermal Growth Factor Receptor Gene Mutations in Lung Adenocarcinomas Qiulu Pan, William Pao, Marc.

Atypical Negative ALK Break-Apart FISH Harboring a Crizotinib-Responsive ALK Rearrangement in Non–Small-Cell Lung Cancer Shengxiang Ren, MD, PhD, Fred.

PTEN and PIK3CA Expression Is Associated with Prolonged Survival after Gefitinib Treatment in EGFR-Mutated Lung Cancer Patients Hideki Endoh, MD, PhD,

Toni-Maree Rogers, BMLS, Prudence A

Immunohistochemistry is a Reliable Screening Tool for Identification of ALK Rearrangement in Non–Small-Cell Lung Carcinoma and is Antibody Dependent

Driven by Mutations: The Predictive Value of Mutation Subtype in EGFR-Mutated Non– Small Cell Lung Cancer Emily Castellanos, MD, Emily Feld, MD, Leora.

Concomitant Epidermal Growth Factor Receptor Mutation and EML4-ALK Fusion in a Patient with Multifocal Lung Adenocarcinomas Jun Fan, MD Journal of Thoracic.

Clinical Implications of Variant ALK FISH Rearrangement Patterns

Highly Sensitive Detection of EGFR T790M Mutation in Pre-TKI Specimens of EGFR- Mutated NSCLC: In Cis, In Trans, or a Different Clone? Alvaro Leone, BSc.D

SWOG S0709: Randomized Phase II Trial of Erlotinib versus Erlotinib Plus Carboplatin/Paclitaxel in Patients with Advanced Non–Small Cell Lung Cancer and.

Christina S. Baik, MD, MPH, Marc C. Chamberlain, MD, Laura Q. Chow, MD

FGFR1 Amplification in Squamous Cell Carcinoma of The Lung

An International Interpretation Study Using the ALK IHC Antibody D5F3 and a Sensitive Detection Kit Demonstrates High Concordance between ALK IHC and.

A Dramatic Response to Crizotinib in a Non–Small-Cell Lung Cancer Patient with IHC- Positive and FISH-Negative ALK Jong-Mu Sun, MD, PhD, Yoon-La Choi,

ALK Gene Rearrangements: A New Therapeutic Target in a Molecularly Defined Subset of Non-small Cell Lung Cancer Benjamin Solomon, MBBS, PhD, Marileila.

A Review of First-Line Treatment for Small-cell Lung Cancer

Presentation transcript:

Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors Neal I. Lindeman, MD, Philip T. Cagle, MD, Dara L. Aisner, MD, PhD, Maria E. Arcila, MD, Mary Beth Beasley, MD, Eric H. Bernicker, MD, Carol Colasacco, MLIS, SCT(ASCP), Sanja Dacic, MD, PhD, Fred R. Hirsch, MD, PhD, Keith Kerr, MB, ChB, David J. Kwiatkowski, MD, PhD, Marc Ladanyi, MD, Jan A. Nowak, MD, PhD, Lynette Sholl, MD, Robyn Temple-Smolkin, PhD, Benjamin Solomon, MBBS, PhD, Lesley H. Souter, PhD, Erik Thunnissen, MD, PhD, Ming S. Tsao, MD, Christina B. Ventura, MPH, MT(ASCP), Murry W. Wynes, PhD, Yasushi Yatabe, MD, PhD Journal of Thoracic Oncology Volume 13, Issue 3, Pages 323-358 (March 2018) DOI: 10.1016/j.jtho.2017.12.001 Copyright © 2018 College of American Pathologists, American Society for Investigative Pathology, Association for Molecular Pathology, and the International Association for the Study of Lung Cancer Terms and Conditions

Figure 1 Forest plot of sensitivity and specificity for immunohistochemistry (IHC)-based determination of ROS1 rearrangement positivity compared with fluorescence in situ hybridization. Pooled estimate of sensitivity and specificity based on bivariate analysis of included studies. All included studies used an IHC staining intensity of at least 2+ with a D4D6 antibody to define ROS1 rearrangement positivity. Abbreviations: FN, false-negative; FP, false-positive; TN, true-negative; TP, true-positive. Journal of Thoracic Oncology 2018 13, 323-358DOI: (10.1016/j.jtho.2017.12.001) Copyright © 2018 College of American Pathologists, American Society for Investigative Pathology, Association for Molecular Pathology, and the International Association for the Study of Lung Cancer Terms and Conditions

Figure 2 Forest plot of sensitivity and specificity for immunohistochemistry-based determination of ALK translocation positivity compared with fluorescence in situ hybridization. Pooled estimate of sensitivity and specificity based on bivariate analysis of included studies. Included studies assessed 5A4, D5F3, or either 5A4 or D5F3 antibodies with positivity cutoffs based on either presence of any staining or staining intensity. Abbreviations: FN, false-negative; FP, false-positive; neg, negative; pos, positive; TN, true-negative; TP, true-positive. Journal of Thoracic Oncology 2018 13, 323-358DOI: (10.1016/j.jtho.2017.12.001) Copyright © 2018 College of American Pathologists, American Society for Investigative Pathology, Association for Molecular Pathology, and the International Association for the Study of Lung Cancer Terms and Conditions

Figure 3 Forest plot of sensitivity and specificity for various assays determining EGFR mutation positivity with cell-free DNA compared with tumor tissue. Pooled estimate of sensitivity and specificity based on bivariate analysis of included studies. Four included studies compared tumor tissue samples with plasma samples using the same detection system,234,235,242,243 and a fifth study232 obtained plasma samples from patients with known EGFR and KRAS tumor mutation status. Abbreviations: ARMs, amplification refractory mutation system; ddPCR, droplet digital PCR; FN, false-negative; FP, false-positive; PCR, polymerase chain reaction; PNA/LNA, peptide nucleic acid–locked nucleic acid; TN, true-negative; TP, true-positive. Journal of Thoracic Oncology 2018 13, 323-358DOI: (10.1016/j.jtho.2017.12.001) Copyright © 2018 College of American Pathologists, American Society for Investigative Pathology, Association for Molecular Pathology, and the International Association for the Study of Lung Cancer Terms and Conditions