Cập nhật Hướng dẫn Xét nghiệm Phân tử trong việc Lựa chọn Bệnh nhân Ung thư Phổi cho điều trị bằng các Inhibitor Tyrosine Kinase Đích: Hướng dẫn từ Hội Pathologists Hoa Kỳ, Hiệp hội Quốc tế Nghiên cứu Ung thư Phổi và Hiệp hội Pathology Phân tử
Tóm tắt
Vào năm 2013, một hướng dẫn dựa trên bằng chứng đã được xuất bản bởi Hội Pathologists Hoa Kỳ, Hiệp hội Quốc tế Nghiên cứu Ung thư Phổi, và Hiệp hội Pathology Phân tử nhằm thiết lập các tiêu chuẩn cho việc phân tích phân tử của ung thư phổi để hướng dẫn quyết định điều trị bằng các inhibitor đích. Những bằng chứng mới đã thúc đẩy việc đánh giá các công nghệ phòng thí nghiệm bổ sung, các gen có thể nhắm đến, quần thể bệnh nhân và loại khối u để kiểm tra.
Để hệ thống hóa xem xét và cập nhật hướng dẫn 2013 nhằm xác nhận tính hợp lệ của nó; đánh giá bằng chứng của những phát hiện di truyền mới, công nghệ và liệu pháp; và phát hành một cập nhật dựa trên bằng chứng.
Hội Pathologists Hoa Kỳ, Hiệp hội Quốc tế Nghiên cứu Ung thư Phổi, và Hiệp hội Pathology Phân tử đã triệu tập một ban chuyên gia để phát triển một hướng dẫn dựa trên bằng chứng nhằm giúp định nghĩa các câu hỏi chính và các thuật ngữ tìm kiếm tài liệu, xem xét các tóm tắt và bài báo đầy đủ, và soạn thảo các khuyến nghị.
Mười tám khuyến nghị mới đã được soạn thảo. Ban cũng đã cập nhật 3 khuyến nghị từ hướng dẫn 2013.
Hướng dẫn 2013 đã được xác nhận phần lớn với các khuyến nghị cập nhật cho phép kiểm tra mẫu tế bào, yêu cầu độ nhạy xét nghiệm được cải thiện, và không khuyến nghị sử dụng miễn dịch hóa mô cho việc kiểm tra EGFR. Các khuyến nghị mới chính bao gồm việc kiểm tra ROS1 cho tất cả bệnh nhân adenocarcinoma; bao gồm các gen bổ sung (ERBB2, MET, BRAF, KRAS, và RET) cho các phòng thí nghiệm thực hiện các bảng giải trình tự thế hệ tiếp theo; miễn dịch hóa mô như một lựa chọn thay thế cho lai hóa huỳnh quang tại chỗ cho việc kiểm tra ALK và/hoặc ROS1; sử dụng các xét nghiệm có độ nhạy 5% cho các đột biến EGFR T790M ở bệnh nhân có kháng thuốc thứ cấp với các inhibitor EGFR; và việc sử dụng DNA tự do trong huyết thanh để "xác nhận" các đột biến có thể nhắm đến khi mô bị hạn chế hoặc khó thu thập.
Từ khóa
Tài liệu tham khảo
Lindeman, 2013, Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology, Arch Pathol Lab Med, 137, 828, 10.5858/arpa.2012-0720-OA
Lindeman, 2013, Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology, J Thorac Oncol, 8, 823, 10.1097/JTO.0b013e318290868f
Lindeman, 2013, Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology, J Mol Diagn, 15, 415, 10.1016/j.jmoldx.2013.03.001
Leighl, 2014, 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, J Clin Oncol, 32, 3673, 10.1200/JCO.2014.57.3055
Ettinger, 2017, NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): non-small cell lung cancer, Version 6.2017. National Comprehensive Cancer Network, Inc
Camps, 2013, SEOM clinical guidelines for the treatment of non-small cell lung cancer (NSCLC) 2013, Clin Transl Oncol, 15, 977, 10.1007/s12094-013-1085-2
Cooper, 2014, National Working Group Meeting on ALK diagnostics in lung cancer, Asia Pac J Clin Oncol, 10, 211
Dietel, 2016, Diagnostic procedures for non-small-cell lung cancer (NSCLC): recommendations of the European Expert Group, Thorax, 71, 177, 10.1136/thoraxjnl-2014-206677
Duffy, 2015, Validation of new cancer biomarkers: a position statement from the European group on tumor markers, Clin Chem, 61, 809, 10.1373/clinchem.2015.239863
Felip, 2015, Biomarker testing in advanced non-small-cell lung cancer: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology, Clin Transl Oncol, 17, 103, 10.1007/s12094-014-1248-9
Garcia-Campelo, 2015, SEOM clinical guidelines for the treatment of non-small cell lung cancer (NSCLC) 2015, Clin Transl Oncol, 17, 1020, 10.1007/s12094-015-1455-z
Gridelli, 2015, Treatment of elderly patients with non-small-cell lung cancer: results of an International Expert Panel Meeting of the Italian Association of Thoracic Oncology, Clin Lung Cancer, 16, 325, 10.1016/j.cllc.2015.02.006
Joseph, 2016, The spectrum of clinical utilities in molecular pathology testing procedures for inherited conditions and cancer: a report of the Association for Molecular Pathology, J Mol Diagn, 18, 605, 10.1016/j.jmoldx.2016.05.007
Kim, 2014, Guideline recommendations for testing of ALK gene rearrangement in lung cancer: a proposal of the Korean Cardiopulmonary Pathology Study Group, Korean J Pathol, 48, 1, 10.4132/KoreanJPathol.2014.48.1.1
Kerr, 2014, Second ESMO consensus conference on lung cancer: pathology and molecular biomarkers for non-small-cell lung cancer, Ann Oncol, 25, 1681, 10.1093/annonc/mdu145
Layfield, 2016, Utilization of ancillary studies in the cytologic diagnosis of respiratory lesions: the Papanicolaou Society of Cytopathology consensus recommendations for respiratory cytology, Diagn Cytopathol, 44, 1000, 10.1002/dc.23549
Li, 2017, Standards and guidelines for the interpretation and reporting of sequence variants in cancer: a joint consensus recommendation of the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists, J Mol Diagn, 19, 4, 10.1016/j.jmoldx.2016.10.002
Liu, 2014, Genomics-based early-phase clinical trials in oncology: recommendations from the Task Force on Methodology for the Development of Innovative Cancer Therapies, Eur J Cancer, 50, 2747, 10.1016/j.ejca.2014.07.027
Melosky, 2016, Canadian consensus: inhibition of ALK-positive tumours in advanced non-small-cell lung cancer, Curr Oncol, 23, 196, 10.3747/co.23.3120
Monso, 2015, Biological marker analysis as part of the CIBERES-RTIC Cancer-SEPAR Strategic Project on Lung Cancer, Arch Bronconeumol, 51, 462, 10.1016/j.arbr.2015.05.005
Popper, 2016, Recommendations of the Austrian Working Group on Pulmonary Pathology and Oncology for predictive molecular and immunohistochemical testing in non-small cell lung cancer, Memo, 9, 191, 10.1007/s12254-016-0297-x
Sepulveda, 2017, Molecular biomarkers for the evaluation of colorectal cancer: guideline from the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology, J Clin Oncol, 35, 1453, 10.1200/JCO.2016.71.9807
van der Heijden, 2014, Guideline for the acquisition and preparation of conventional and endobronchial ultrasound-guided transbronchial needle aspiration specimens for the diagnosis and molecular testing of patients with known or suspected lung cancer, Respiration, 88, 500, 10.1159/000368857
Villar Alvarez, 2016, Executive summary of the SEPAR recommendations for the diagnosis and treatment of non-small cell lung cancer, Arch Bronconeumol, 52, 378, 10.1016/j.arbr.2016.02.020
von Laffert, 2017, ALK-testing in non-small cell lung cancer (NSCLC): immunohistochemistry (IHC) and/or fluorescence in-situ hybridisation (FISH)?: statement of the Germany Society for Pathology (DGP) and the Working Group Thoracic Oncology (AIO) of the German Cancer Society e.V. (Stellungnahme der Deutschen Gesellschaft fur Pathologie und der AG Thorakale Onkologie der Arbeitsgemeinschaft Onkologie/Deutsche Krebsgesellschaft e.V.), Lung Cancer, 103, 1, 10.1016/j.lungcan.2016.11.008
Scottish Intercollegiate Guidelines Network (SIGN), 2014, Management of lung cancer, SIGN publication no. 137
Yale University School of Medicine, 2017, GuideLines Into DEcision Support (GLIDES)
Ellison, 2013, EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumour tissue and cytology samples, J Clin Pathol, 66, 79, 10.1136/jclinpath-2012-201194
Kitamura, 2010, Immunohistochemical detection of EGFR mutation using mutation-specific antibodies in lung cancer, Clin Cancer Res, 16, 3349, 10.1158/1078-0432.CCR-10-0129
Bergethon, 2012, ROS1 rearrangements define a unique molecular class of lung cancers, J Clin Oncol, 30, 863, 10.1200/JCO.2011.35.6345
Go, 2013, Clinicopathologic analysis of ROS1-rearranged non-small-cell lung cancer and proposal of a diagnostic algorithm, J Thorac Oncol, 8, 1445, 10.1097/JTO.0b013e3182a4dd6e
Mazieres, 2015, Crizotinib therapy for advanced lung adenocarcinoma and a ROS1 rearrangement: results from the EUROS1 cohort, J Clin Oncol, 33, 992, 10.1200/JCO.2014.58.3302
Shaw, 2014, Crizotinib in ROS1-rearranged non-small-cell lung cancer, N Engl J Med, 371, 1963, 10.1056/NEJMoa1406766
Cai, 2013, ROS1 fusions in Chinese patients with non-small-cell lung cancer, Ann Oncol, 24, 1822, 10.1093/annonc/mdt071
Chen, 2014, Clinical and the prognostic characteristics of lung adenocarcinoma patients with ROS1 fusion in comparison with other driver mutations in East Asian populations, J Thorac Oncol, 9, 1171, 10.1097/JTO.0000000000000232
Warth, 2014, ROS1 expression and translocations in non-small-cell lung cancer: clinicopathological analysis of 1478 cases, Histopathology, 65, 187, 10.1111/his.12379
Lee, 2015, Comprehensive analysis of RET and ROS1 rearrangement in lung adenocarcinoma, Mod Pathol, 28, 468, 10.1038/modpathol.2014.107
Scheffler, 2015, ROS1 rearrangements in lung adenocarcinoma: prognostic impact, therapeutic options and genetic variability, Oncotarget, 6, 10577, 10.18632/oncotarget.3387
Kim, 2013, The frequency and impact of ROS1 rearrangement on clinical outcomes in never smokers with lung adenocarcinoma, Ann Oncol, 24, 2364, 10.1093/annonc/mdt220
Kemner, 2017, Phase II safety and efficacy study of crizotinib in East Asian patients with ROS1 positive, ALK negative advanced NSCLC (NCT01945021)
US Food and Drug Administration, 2017, XALKORI prescribing information
Cha, 2014, Screening of ROS1 rearrangements in lung adenocarcinoma by immunohistochemistry and comparison with ALK rearrangements, PLoS One, 9, e103333, 10.1371/journal.pone.0103333
Mescam-Mancini, 2014, On the relevance of a testing algorithm for the detection of ROS1-rearranged lung adenocarcinomas, Lung Cancer, 83, 168, 10.1016/j.lungcan.2013.11.019
Sholl, 2013, ROS1 immunohistochemistry for detection of ROS1-rearranged lung adenocarcinomas, Am J Surg Pathol, 37, 1441, 10.1097/PAS.0b013e3182960fa7
Yoshida, 2014, Immunohistochemical detection of ROS1 is useful for identifying ROS1 rearrangements in lung cancers, Mod Pathol, 27, 711, 10.1038/modpathol.2013.192
Boyle, 2015, ROS1 immunohistochemistry among major genotypes of non-small-cell lung cancer, Clin Lung Cancer, 16, 106, 10.1016/j.cllc.2014.10.003
Shan, 2015, Detection of ROS1 gene rearrangement in lung adenocarcinoma: comparison of IHC, FISH and real-time RT-PCR, PLoS One, 10, e0120422, 10.1371/journal.pone.0120422
Wiesweg, 2017, High prevalence of concomitant oncogene mutations in prospectively identified patients with ROS1-positive metastatic lung cancer, J Thorac Oncol, 12, 54, 10.1016/j.jtho.2016.08.137
Hsu, 2015, Identification of five driver gene mutations in patients with treatment-naive lung adenocarcinoma in Taiwan, PLoS One, 10, e0120852, 10.1371/journal.pone.0120852
Kinno, 2014, Clinicopathological features of nonsmall cell lung carcinomas with BRAF mutations, Ann Oncol, 25, 138, 10.1093/annonc/mdt495
Li, 2013, Frequency of well-identified oncogenic driver mutations in lung adenocarcinoma of smokers varies with histological subtypes and graduated smoking dose, Lung Cancer, 79, 8, 10.1016/j.lungcan.2012.09.018
Li, 2014, Coexistence of EGFR with KRAS, or BRAF, or PIK3CA somatic mutations in lung cancer: a comprehensive mutation profiling from 5125 Chinese cohorts, Br J Cancer, 110, 2812, 10.1038/bjc.2014.210
Cardarella, 2013, Clinical, pathologic, and biologic features associated with BRAF mutations in non-small cell lung cancer, Clin Cancer Res, 19, 4532, 10.1158/1078-0432.CCR-13-0657
Marchetti, 2011, Clinical features and outcome of patients with non-small-cell lung cancer harboring BRAF mutations, J Clin Oncol, 29, 3574, 10.1200/JCO.2011.35.9638
Brustugun, 2014, BRAF-mutations in non-small cell lung cancer, Lung Cancer, 84, 36, 10.1016/j.lungcan.2014.01.023
Planchard, 2016, Dabrafenib in patients with BRAF(V600E)-positive advanced non-small-cell lung cancer: a single-arm, multicentre, open-label, phase 2 trial, Lancet Oncol, 17, 642, 10.1016/S1470-2045(16)00077-2
Planchard, 2016, Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial, Lancet Oncol, 17, 984, 10.1016/S1470-2045(16)30146-2
Ilie, 2013, Diagnostic value of immunohistochemistry for the detection of the BRAFV600E mutation in primary lung adenocarcinoma Caucasian patients, Ann Oncol, 24, 742, 10.1093/annonc/mds534
Smit, 2014, BRAF mutations in non-small-cell lung cancer, J Thorac Oncol, 9, 1594, 10.1097/JTO.0000000000000382
Sasaki, 2013, Usefulness of immunohistochemistry for the detection of the BRAF V600E mutation in Japanese lung adenocarcinoma, Lung Cancer, 82, 51, 10.1016/j.lungcan.2013.06.014
Ilie, 2015, Discrepancies between FISH and immunohistochemistry for assessment of the ALK status are associated with ALK “borderline”-positive rearrangements or a high copy number: a potential major issue for anti-ALK therapeutic strategies, Ann Oncol, 26, 238, 10.1093/annonc/mdu484
Wang, 2012, RET fusions define a unique molecular and clinicopathologic subtype of non-small-cell lung cancer, J Clin Oncol, 30, 4352, 10.1200/JCO.2012.44.1477
Tsai, 2015, Clinical and prognostic implications of RET rearrangements in metastatic lung adenocarcinoma patients with malignant pleural effusion, Lung Cancer, 88, 208, 10.1016/j.lungcan.2015.02.018
Suehara, 2012, Identification of KIF5B-RET and GOPC-ROS1 fusions in lung adenocarcinomas through a comprehensive mRNA-based screen for tyrosine kinase fusions, Clin Cancer Res, 18, 6599, 10.1158/1078-0432.CCR-12-0838
Lipson, 2012, Identification of new ALK and RET gene fusions from colorectal and lung cancer biopsies, Nat Med, 18, 382, 10.1038/nm.2673
Yoh, 2017, Vandetanib in patients with previously treated RET-rearranged advanced non-small-cell lung cancer (LURET): an open-label, multicentre phase 2 trial, Lancet Respir Med, 5, 42, 10.1016/S2213-2600(16)30322-8
Drilon, 2016, Cabozantinib in patients with advanced RET-rearranged non-small-cell lung cancer: an open-label, single-centre, phase 2, single-arm trial, Lancet Oncol, 17, 1653, 10.1016/S1470-2045(16)30562-9
Gautschi, 2017, Targeting RET in patients with RET-rearranged lung cancers: results from the global, multicenter RET registry, J Clin Oncol, 35, 1403, 10.1200/JCO.2016.70.9352
Gautschi, 2013, A patient with lung adenocarcinoma and RET fusion treated with vandetanib, J Thorac Oncol, 8, e43, 10.1097/JTO.0b013e31828a4d07
Drilon, 2013, Response to cabozantinib in patients with RET fusion-positive lung adenocarcinomas, Cancer Discov, 3, 630, 10.1158/2159-8290.CD-13-0035
Thunnissen, 2014, Prognostic and predictive biomarkers in lung cancer: a review, Virchows Arch, 464, 347, 10.1007/s00428-014-1535-4
Li, 2012, Identification of RET gene fusion by exon array analyses in “pan-negative” lung cancer from never smokers, Cell Res, 22, 928, 10.1038/cr.2012.27
Sasaki, 2012, RET expression and detection of KIF5B/RET gene rearrangements in Japanese lung cancer, Cancer Med, 1, 68, 10.1002/cam4.13
Zheng, 2014, Anchored multiplex PCR for targeted next-generation sequencing, Nat Med, 20, 1479, 10.1038/nm.3729
Aleric, 2012, HER-2/neu oncogene and estrogen receptor expression in non small cell lung cancer patients, Med Pregl, 65, 210, 10.2298/MPNS1206210A
Calikusu, 2009, Prognostic significance of the C-erbB-2 expression in Turkish non-small cell lung cancer patients, Asian Pac J Cancer Prev, 10, 479
Liu, 2010, The role of human epidermal growth factor receptor 2 as a prognostic factor in lung cancer: a meta-analysis of published data, J Thorac Oncol, 5, 1922, 10.1097/JTO.0b013e3181f26266
Tomizawa, 2011, Prognostic and predictive implications of HER2/ERBB2/neu gene mutations in lung cancers, Lung Cancer, 74, 139, 10.1016/j.lungcan.2011.01.014
Arcila, 2012, Prevalence, clinicopathologic associations, and molecular spectrum of ERBB2 (HER2) tyrosine kinase mutations in lung adenocarcinomas, Clin Cancer Res, 18, 4910, 10.1158/1078-0432.CCR-12-0912
Yoshizawa, 2014, HER2 status in lung adenocarcinoma: a comparison of immunohistochemistry, fluorescence in situ hybridization (FISH), dual-ISH, and gene mutations, Lung Cancer, 85, 373, 10.1016/j.lungcan.2014.06.007
Shan, 2015, Prevalence and clinicopathological characteristics of HER2 and BRAF mutation in Chinese patients with lung adenocarcinoma, PLoS One, 10, e0130447, 10.1371/journal.pone.0130447
Suzuki, 2015, HER2 gene mutations in non-small cell lung carcinomas: concurrence with Her2 gene amplification and Her2 protein expression and phosphorylation, Lung Cancer, 87, 14, 10.1016/j.lungcan.2014.10.014
Kris, 2015, Targeting HER2 aberrations as actionable drivers in lung cancers: phase II trial of the pan-HER tyrosine kinase inhibitor dacomitinib in patients with HER2-mutant or amplified tumors, Ann Oncol, 26, 1421, 10.1093/annonc/mdv186
Li, 2012, Lung adenocarcinomas with HER2-activating mutations are associated with distinct clinical features and HER2/EGFR copy number gains, J Thorac Oncol, 7, 85, 10.1097/JTO.0b013e318234f0a2
Gatzemeier, 2004, Randomized phase II trial of gemcitabine-cisplatin with or without trastuzumab in HER2-positive non-small-cell lung cancer, Ann Oncol, 15, 19, 10.1093/annonc/mdh031
Krug, 2005, Randomized phase II study of weekly docetaxel plus trastuzumab versus weekly paclitaxel plus trastuzumab in patients with previously untreated advanced nonsmall cell lung carcinoma, Cancer, 104, 2149, 10.1002/cncr.21428
Li, 2016, HER2 amplification and HER2 mutation are distinct molecular targets in lung cancers, J Thorac Oncol, 11, 414, 10.1016/j.jtho.2015.10.025
Takezawa, 2012, HER2 amplification: a potential mechanism of acquired resistance to EGFR inhibition in EGFR-mutant lung cancers that lack the second-site EGFRT790M mutation, Cancer Discov, 2, 922, 10.1158/2159-8290.CD-12-0108
Chuang, 2017, ERBB2-mutated metastatic non-small cell lung cancer: response and resistance to targeted therapies, J Thorac Oncol, 12, 833, 10.1016/j.jtho.2017.01.023
Fiala, 2013, The dominant role of G12C over other KRAS mutation types in the negative prediction of efficacy of epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer, Cancer Genet, 206, 26, 10.1016/j.cancergen.2012.12.003
Mao, 2010, KRAS mutations and resistance to EGFR-TKIs treatment in patients with non-small cell lung cancer: a meta-analysis of 22 studies, Lung Cancer, 69, 272, 10.1016/j.lungcan.2009.11.020
Meng, 2013, Prognostic value of K-RAS mutations in patients with non-small cell lung cancer: a systematic review with meta-analysis, Lung Cancer, 81, 1, 10.1016/j.lungcan.2013.03.019
Yeung, 2015, Profiling of oncogenic driver events in lung adenocarcinoma revealed MET mutation as independent prognostic factor, J Thorac Oncol, 10, 1292, 10.1097/JTO.0000000000000620
Leidner, 2009, Genetic abnormalities of the EGFR pathway in African American patients with non-small-cell lung cancer, J Clin Oncol, 27, 5620, 10.1200/JCO.2009.23.1431
Reinersman, 2011, Frequency of EGFR and KRAS mutations in lung adenocarcinomas in African Americans, J Thorac Oncol, 6, 28, 10.1097/JTO.0b013e3181fb4fe2
Shigematsu, 2005, Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers, J Natl Cancer Inst, 97, 339, 10.1093/jnci/dji055
Riely, 2008, Frequency and distinctive spectrum of KRAS mutations in never smokers with lung adenocarcinoma, Clin Cancer Res, 14, 5731, 10.1158/1078-0432.CCR-08-0646
Thu, 2012, Lung adenocarcinoma of never smokers and smokers harbor differential regions of genetic alteration and exhibit different levels of genomic instability, PLoS One, 7, e33003, 10.1371/journal.pone.0033003
Broet, 2011, Genomic profiles specific to patient ethnicity in lung adenocarcinoma, Clin Cancer Res, 17, 3542, 10.1158/1078-0432.CCR-10-2185
Janne, 2013, Selumetinib plus docetaxel for KRAS-mutant advanced non-small-cell lung cancer: a randomised, multicentre, placebo-controlled, phase 2 study, Lancet Oncol, 14, 38, 10.1016/S1470-2045(12)70489-8
Janne, 2017, Selumetinib plus docetaxel compared with docetaxel alone and progression-free survival in patients with KRAS-mutant advanced non-small cell lung cancer: the SELECT-1 randomized clinical trial, JAMA, 317, 1844, 10.1001/jama.2017.3438
Carter, 2016, Selumetinib with and without erlotinib in KRAS mutant and KRAS wild-type advanced nonsmall-cell lung cancer, Ann Oncol, 27, 693, 10.1093/annonc/mdw008
Guibert, 2017, Characteristics and outcomes of patients with lung cancer harboring multiple molecular alterations: results from the IFCT study Biomarkers France, J Thorac Oncol, 12, 963, 10.1016/j.jtho.2017.02.001
Scheffler, 2016, Genetic heterogeneity of KRAS-mutated NSCLC: co-occurrence of potentially targetable aberrations and evolutionary background [ASCO meeting abstract], J Clin Oncol, 34, 9018, 10.1200/JCO.2016.34.15_suppl.9018
Guo, 2014, Prognostic value of MET gene copy number and protein expression in patients with surgically resected non-small cell lung cancer: a meta-analysis of published literatures, PLoS One, 9, e99399, 10.1371/journal.pone.0099399
Jin, 2014, MET gene copy number gain is an independent poor prognostic marker in Korean stage I lung adenocarcinomas, Ann Surg Oncol, 21, 621, 10.1245/s10434-013-3355-1
Spigel, 2013, Randomized phase II trial of Onartuzumab in combination with erlotinib in patients with advanced non-small-cell lung cancer, J Clin Oncol, 31, 4105, 10.1200/JCO.2012.47.4189
Kowalczuk, 2014, Increased MET gene copy number but not mRNA level predicts postoperative recurrence in patients with non-small cell lung cancer, Transl Oncol, 7, 605, 10.1016/j.tranon.2014.08.002
Jurmeister, 2015, Parallel screening for ALK, MET and ROS1 alterations in non-small cell lung cancer with implications for daily routine testing, Lung Cancer, 87, 122, 10.1016/j.lungcan.2014.11.018
Noro, 2015, MET FISH-positive status predicts short progression-free survival and overall survival after gefitinib treatment in lung adenocarcinoma with EGFR mutation, BMC Cancer, 15, 31, 10.1186/s12885-015-1019-1
Weingertner, 2015, Correlation between MET protein expression and MET gene copy number in a Caucasian cohort of non-small cell lung cancers according to the new IASLC/ATS/ERS classification, Pathology, 47, 320, 10.1097/PAT.0000000000000269
Engelman, 2007, MET amplification leads to gefitinib resistance in lung cancer by activating ERBB3 signaling, Science, 316, 1039, 10.1126/science.1141478
Piotrowska, 2015, Epidermal growth factor receptor-mutant lung cancer: new drugs, new resistance mechanisms, and future treatment options, Cancer J, 21, 371, 10.1097/PPO.0000000000000147
Spigel, 2017, Results from the phase III randomized trial of onartuzumab plus erlotinib versus erlotinib in previously treated stage IIIB or IV non-small-cell lung cancer: METLung, J Clin Oncol, 35, 412, 10.1200/JCO.2016.69.2160
Trusolino, 2010, MET signalling: principles and functions in development, organ regeneration and cancer, Nat Rev Mol Cell Biol, 11, 834, 10.1038/nrm3012
Gherardi, 2012, Targeting MET in cancer: rationale and progress, Nat Rev Cancer, 12, 89, 10.1038/nrc3205
Sierra, 2011, c-MET as a potential therapeutic target and biomarker in cancer, Ther Adv Med Oncol, 3, S21, 10.1177/1758834011422557
Feng, 2012, MET signaling: novel targeted inhibition and its clinical development in lung cancer, J Thorac Oncol, 7, 459, 10.1097/JTO.0b013e3182417e44
Lutterbach, 2007, Lung cancer cell lines harboring MET gene amplification are dependent on Met for growth and survival, Cancer Res, 67, 2081, 10.1158/0008-5472.CAN-06-3495
Gainor, 2016, Dramatic response to combination erlotinib and crizotinib in a patient with advanced, EGFR-mutant lung cancer harboring de novo MET amplification, J Thorac Oncol, 11, e83, 10.1016/j.jtho.2016.02.021
Jeffers, 1997, Activating mutations for the met tyrosine kinase receptor in human cancer, Proc Natl Acad Sci U S A, 94, 11445, 10.1073/pnas.94.21.11445
Ma, 2015, MET receptor juxtamembrane exon 14 alternative spliced variant: novel cancer genomic predictive biomarker, Cancer Discov, 5, 802, 10.1158/2159-8290.CD-15-0769
Tong, 2016, MET Amplification and exon 14 splice site mutation define unique molecular subgroups of non-small cell lung carcinoma with poor prognosis, Clin Cancer Res, 22, 3048, 10.1158/1078-0432.CCR-15-2061
Paik, 2015, Response to MET inhibitors in patients with stage IV lung adenocarcinomas harboring MET mutations causing exon 14 skipping, Cancer Discov, 5, 842, 10.1158/2159-8290.CD-14-1467
Frampton, 2015, Activation of MET via diverse exon 14 splicing alterations occurs in multiple tumor types and confers clinical sensitivity to MET inhibitors, Cancer Discov, 5, 850, 10.1158/2159-8290.CD-15-0285
Heist, 2016, MET exon 14 skipping in non-small cell lung cancer, Oncologist, 21, 481, 10.1634/theoncologist.2015-0510
Awad, 2016, MET exon 14 mutations in non-small-cell lung cancer are associated with advanced age and stage-dependent MET genomic amplification and c-Met overexpression, J Clin Oncol, 34, 721, 10.1200/JCO.2015.63.4600
Liu, 2016, Next-generation sequencing of pulmonary sarcomatoid carcinoma reveals high frequency of actionable MET gene mutations, J Clin Oncol, 34, 794, 10.1200/JCO.2015.62.0674
Dziadziuszko, 2012, Correlation between MET gene copy number by silver in situ hybridization and protein expression by immunohistochemistry in non-small cell lung cancer, J Thorac Oncol, 7, 340, 10.1097/JTO.0b013e318240ca0d
Cappuzzo, 2009, Increased MET gene copy number negatively affects survival of surgically resected non-small-cell lung cancer patients, J Clin Oncol, 27, 1667, 10.1200/JCO.2008.19.1635
Noonan, 2016, Identifying the appropriate FISH criteria for defining MET copy number-driven lung adenocarcinoma through oncogene overlap analysis, J Thorac Oncol, 11, 1293, 10.1016/j.jtho.2016.04.033
Ou, 2011, Activity of crizotinib (PF02341066), a dual mesenchymal-epithelial transition (MET) and anaplastic lymphoma kinase (ALK) inhibitor, in a non-small cell lung cancer patient with de novo MET amplification, J Thorac Oncol, 6, 942, 10.1097/JTO.0b013e31821528d3
Caparica, 2017, Responses to crizotinib can occur in high-level MET-amplified non-small cell lung cancer independent of MET exon 14 alterations, J Thorac Oncol, 12, 141, 10.1016/j.jtho.2016.09.116
Wu, 2014, Safety and efficacy of INC280 in combination with gefitinib (gef) in patients with EGFR-mutated (mut), MET-positive NSCLC: a single-arm phase Ib/II study, J Clin Oncol, 32, 8017, 10.1200/jco.2014.32.15_suppl.8017
Tsuta, 2012, c-MET/phospho-MET protein expression and MET gene copy number in non-small cell lung carcinomas, J Thorac Oncol, 7, 331, 10.1097/JTO.0b013e318241655f
Koeppen, 2014, Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib ± onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit, Clin Cancer Res, 20, 4488, 10.1158/1078-0432.CCR-13-1836
McLeer-Florin, 2012, Dual IHC and FISH testing for ALK gene rearrangement in lung adenocarcinomas in a routine practice: a French study, J Thorac Oncol, 7, 348, 10.1097/JTO.0b013e3182381535
Sholl, 2013, Combined use of ALK immunohistochemistry and FISH for optimal detection of ALK-rearranged lung adenocarcinomas, J Thorac Oncol, 8, 322, 10.1097/JTO.0b013e31827db604
Park, 2012, Immunohistochemical screening for anaplastic lymphoma kinase (ALK) rearrangement in advanced non-small cell lung cancer patients, Lung Cancer, 77, 288, 10.1016/j.lungcan.2012.03.004
Minca, 2013, ALK status testing in non-small cell lung carcinoma: correlation between ultrasensitive IHC and FISH, J Mol Diagn, 15, 341, 10.1016/j.jmoldx.2013.01.004
To, 2013, Detection of ALK rearrangement by immunohistochemistry in lung adenocarcinoma and the identification of a novel EML4-ALK variant, J Thorac Oncol, 8, 883, 10.1097/JTO.0b013e3182904e22
Blackhall, 2014, Prevalence and clinical outcomes for patients with ALK-positive resected stage I to III adenocarcinoma: results from the European Thoracic Oncology Platform Lungscape Project, J Clin Oncol, 32, 2780, 10.1200/JCO.2013.54.5921
Conde, 2014, Accurate identification of ALK positive lung carcinoma patients: novel FDA-cleared automated fluorescence in situ hybridization scanning system and ultrasensitive immunohistochemistry, PLoS One, 9, e107200, 10.1371/journal.pone.0107200
Cutz, 2014, Canadian anaplastic lymphoma kinase study: a model for multicenter standardization and optimization of ALK testing in lung cancer, J Thorac Oncol, 9, 1255, 10.1097/JTO.0000000000000239
Tantraworasin, 2014, Retrospective study of ALK rearrangement and clinicopathological implications in completely resected non-small cell lung cancer patients in northern Thailand: role of screening with D5F3 antibodies, Asian Pac J Cancer Prev, 15, 3057, 10.7314/APJCP.2014.15.7.3057
Wang, 2014, Clinical characteristics and outcomes of patients with primary lung adenocarcinoma harboring ALK rearrangements detected by FISH, IHC, and RT-PCR, PLoS One, 9, e101551, 10.1371/journal.pone.0101551
Yang, 2012, Worse disease-free survival in never-smokers with ALK+ lung adenocarcinoma, J Thorac Oncol, 7, 90, 10.1097/JTO.0b013e31823c5c32
Ying, 2013, Diagnostic value of a novel fully automated immunochemistry assay for detection of ALK rearrangement in primary lung adenocarcinoma, Ann Oncol, 24, 2589, 10.1093/annonc/mdt295
Shan, 2014, Combination of conventional immunohistochemistry and qRT-PCR to detect ALK rearrangement, Diagn Pathol, 9, 3, 10.1186/1746-1596-9-3
Zwaenepoel, 2014, Detection of ALK expression in non-small-cell lung cancer with ALK gene rearrangements—comparison of multiple immunohistochemical methods, Histopathology, 65, 539, 10.1111/his.12414
Gruber, 2015, A novel, highly sensitive ALK antibody 1A4 facilitates effective screening for ALK rearrangements in lung adenocarcinomas by standard immunohistochemistry, J Thorac Oncol, 10, 713, 10.1097/JTO.0000000000000427
Lantuejoul, 2015, French multicentric validation of ALK rearrangement diagnostic in 547 lung adenocarcinomas, Eur Respir J, 46, 201, 10.1183/09031936.00119914
Savic, 2015, Screening for ALK in non-small cell lung carcinomas: 5A4 and D5F3 antibodies perform equally well, but combined use with FISH is recommended, Lung Cancer, 89, 104, 10.1016/j.lungcan.2015.05.012
Ali, 2014, ALK rearrangement in a large series of consecutive non-small cell lung cancers: comparison between a new immunohistochemical approach and fluorescence in situ hybridization for the screening of patients eligible for crizotinib treatment, Arch Pathol Lab Med, 138, 1449, 10.5858/arpa.2013-0388-OA
Hutarew, 2014, Immunohistochemistry as a screening tool for ALK rearrangement in NSCLC: evaluation of five different ALK antibody clones and ALK FISH, Histopathology, 65, 398, 10.1111/his.12399
Mino-Kenudson, 2010, A novel, highly sensitive antibody allows for the routine detection of ALK-rearranged lung adenocarcinomas by standard immunohistochemistry, Clin Cancer Res, 16, 1561, 10.1158/1078-0432.CCR-09-2845
Rodig, 2009, Unique clinicopathologic features characterize ALK-rearranged lung adenocarcinoma in the western population, Clin Cancer Res, 15, 5216, 10.1158/1078-0432.CCR-09-0802
Shaw, 2009, Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK, J Clin Oncol, 27, 4247, 10.1200/JCO.2009.22.6993
Kim, 2011, Detection of ALK gene rearrangement in non-small cell lung cancer: a comparison of fluorescence in situ hybridization and chromogenic in situ hybridization with correlation of ALK protein expression, J Thorac Oncol, 6, 1359, 10.1097/JTO.0b013e31821cfc73
Marchetti, 2016, ALK protein analysis by IHC staining after recent regulatory changes: a comparison of two widely used approaches, revision of the literature, and a new testing algorithm, J Thorac Oncol, 11, 487, 10.1016/j.jtho.2015.12.111
Pekar-Zlotin, 2015, Fluorescence in situ hybridization, immunohistochemistry, and next-generation sequencing for detection of EML4-ALK rearrangement in lung cancer, Oncologist, 20, 316, 10.1634/theoncologist.2014-0389
Gao, 2015, Clinical Implications of variant ALK FISH rearrangement patterns, J Thorac Oncol, 10, 1648, 10.1097/JTO.0000000000000665
Dacic, 2016, FISH patterns and the detection of ALK fusions by next generation sequencing in lung adenocarcinoma, Oncotarget, 7, 82943, 10.18632/oncotarget.12705
Cabillic, 2014, Parallel FISH and immunohistochemical studies of ALK status in 3244 non-small-cell lung cancers reveal major discordances, J Thorac Oncol, 9, 295, 10.1097/JTO.0000000000000072
Li, 2016, Reliability assurance of detection of EML4-ALK rearrangement in non-small cell lung cancer: the results of proficiency testing in China, J Thorac Oncol, 11, 924, 10.1016/j.jtho.2016.03.004
Soda, 2012, A prospective PCR-based screening for the EML4-ALK oncogene in non-small cell lung cancer, Clin Cancer Res, 18, 5682, 10.1158/1078-0432.CCR-11-2947
Drilon, 2015, Broad, hybrid capture-based next-generation sequencing identifies actionable genomic alterations in lung adenocarcinomas otherwise negative for such alterations by other genomic testing approaches, Clin Cancer Res, 21, 3631, 10.1158/1078-0432.CCR-14-2683
Su, 2014, Detecting the spectrum of multigene mutations in non-small cell lung cancer by Snapshot assay, Chin J Cancer, 33, 346
Han, 2014, Comparison of targeted next-generation sequencing with conventional sequencing for predicting the responsiveness to epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy in never-smokers with lung adenocarcinoma, Lung Cancer, 85, 161, 10.1016/j.lungcan.2014.04.009
Tuononen, 2013, Comparison of targeted next-generation sequencing (NGS) and real-time PCR in the detection of EGFR, KRAS, and BRAF mutations on formalin-fixed, paraffin-embedded tumor material of non-small cell lung carcinoma—superiority of NGS, Genes Chromosomes Cancer, 52, 503, 10.1002/gcc.22047
Scarpa, 2013, Molecular typing of lung adenocarcinoma on cytological samples using a multigene next generation sequencing panel, PLoS One, 8, e80478, 10.1371/journal.pone.0080478
Jennings, 2017, Guidelines for validation of next-generation sequencing-based oncology panels: a joint consensus recommendation of the Association for Molecular Pathology and College of American Pathologists, J Mol Diagn, 19, 341, 10.1016/j.jmoldx.2017.01.011
Endris, 2013, Molecular diagnostic profiling of lung cancer specimens with a semiconductor-based massive parallel sequencing approach: feasibility, costs, and performance compared with conventional sequencing, J Mol Diagn, 15, 765, 10.1016/j.jmoldx.2013.06.002
Head, 2014, Library construction for next-generation sequencing: overviews and challenges, Biotechniques, 56, 61, 10.2144/000114133
Rekhtman, 2012, Clarifying the spectrum of driver oncogene mutations in biomarker-verified squamous carcinoma of lung: lack of EGFR/KRAS and presence of PIK3CA/AKT1 mutations, Clin Cancer Res, 18, 1167, 10.1158/1078-0432.CCR-11-2109
Ludovini, 2011, Phosphoinositide-3-kinase catalytic alpha and KRAS mutations are important predictors of resistance to therapy with epidermal growth factor receptor tyrosine kinase inhibitors in patients with advanced non-small cell lung cancer, J Thorac Oncol, 6, 707, 10.1097/JTO.0b013e31820a3a6b
Hirsch, 2007, Combination of EGFR gene copy number and protein expression predicts outcome for advanced non-small-cell lung cancer patients treated with gefitinib, Ann Oncol, 18, 752, 10.1093/annonc/mdm003
Massarelli, 2007, KRAS mutation is an important predictor of resistance to therapy with epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer, Clin Cancer Res, 13, 2890, 10.1158/1078-0432.CCR-06-3043
Inamura, 2009, EML4-ALK lung cancers are characterized by rare other mutations, a TTF-1 cell lineage, an acinar histology, and young onset, Mod Pathol, 22, 508, 10.1038/modpathol.2009.2
Shaw, 2011, Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis, Lancet Oncol, 12, 1004, 10.1016/S1470-2045(11)70232-7
Girard, 2012, Nomogram to predict the presence of EGFR activating mutation in lung adenocarcinoma, Eur Respir J, 39, 366, 10.1183/09031936.00010111
Dogan, 2012, Molecular epidemiology of EGFR and KRAS mutations in 3,026 lung adenocarcinomas: higher susceptibility of women to smoking-related KRAS-mutant cancers, Clin Cancer Res, 18, 6169, 10.1158/1078-0432.CCR-11-3265
Wu, 2008, Reversed mutation rates of KRAS and EGFR genes in adenocarcinoma of the lung in Taiwan and their implications, Cancer, 113, 3199, 10.1002/cncr.23925
Marks, 2008, Prognostic and therapeutic implications of EGFR and KRAS mutations in resected lung adenocarcinoma, J Thorac Oncol, 3, 111, 10.1097/JTO.0b013e318160c607
Molina-Vila, 2008, A sensitive method for detecting EGFR mutations in non-small cell lung cancer samples with few tumor cells, J Thorac Oncol, 3, 1224, 10.1097/JTO.0b013e318189f579
Kawada, 2008, An alternative method for screening EGFR mutation using RFLP in non-small cell lung cancer patients, J Thorac Oncol, 3, 1096, 10.1097/JTO.0b013e318186fadd
Lee, 2009, Activating mutations within the EGFR kinase domain: a molecular predictor of disease-free survival in resected pulmonary adenocarcinoma, J Cancer Res Clin Oncol, 135, 1647, 10.1007/s00432-009-0611-7
Soh, 2007, Impact of HER2 and EGFR gene status on gefitinib-treated patients with nonsmall-cell lung cancer, Int J Cancer, 121, 1162, 10.1002/ijc.22818
Cohen, 2010, Epidermal growth factor receptor mutations detected by denaturing high-performance liquid chromatography in nonsmall cell lung cancer: impact on response to therapy with epidermal growth factor receptor-tyrosine kinase inhibitors, Cancer, 116, 4309, 10.1002/cncr.25214
Harada, 2011, Characterization of epidermal growth factor receptor mutations in non-small-cell lung cancer patients of African-American ancestry, Oncogene, 30, 1744, 10.1038/onc.2010.545
Hotta, 2007, Clinical significance of epidermal growth factor receptor gene mutations on treatment outcome after first-line cytotoxic chemotherapy in Japanese patients with non-small cell lung cancer, J Thorac Oncol, 2, 632, 10.1097/JTO.0b013e318074bc0d
Kondo, 2005, Mutations of epidermal growth factor receptor of non-small cell lung cancer were associated with sensitivity to gefitinib in recurrence after surgery, Lung Cancer, 50, 385, 10.1016/j.lungcan.2005.06.008
Porta, 2011, Brain metastases from lung cancer responding to erlotinib: the importance of EGFR mutation, Eur Respir J, 37, 624, 10.1183/09031936.00195609
Sasaki, 2008, Epidermal growth factor receptor gene amplification and gefitinib sensitivity in patients with recurrent lung cancer, J Cancer Res Clin Oncol, 134, 569, 10.1007/s00432-007-0320-z
Satouchi, 2007, Predictive factors associated with prolonged survival in patients with advanced non-small-cell lung cancer (NSCLC) treated with gefitinib, Br J Cancer, 96, 1191, 10.1038/sj.bjc.6603710
Taron, 2005, Activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor are associated with improved survival in gefitinib-treated chemorefractory lung adenocarcinomas, Clin Cancer Res, 11, 5878, 10.1158/1078-0432.CCR-04-2618
Uramoto, 2006, Epidermal growth factor receptor mutations are associated with gefitinib sensitivity in non-small cell lung cancer in Japanese, Lung Cancer, 51, 71, 10.1016/j.lungcan.2005.08.006
Wang, 2008, EGFR/KRAS mutations and gefitinib therapy in Chinese NSCLC patients, Onkologie, 31, 174, 10.1159/000116736
Xu, 2009, EGFR mutations and HER2/3 protein expression and clinical outcome in Chinese advanced non-small cell lung cancer patients treated with gefitinib, J Cancer Res Clin Oncol, 135, 771, 10.1007/s00432-008-0512-1
Wu, 2011, Gefitinib therapy in patients with advanced non-small cell lung cancer with or without testing for epidermal growth factor receptor (EGFR) mutations, Medicine (Baltimore), 90, 159, 10.1097/MD.0b013e31821a16f4
Asahina, 2006, A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations, Br J Cancer, 95, 998, 10.1038/sj.bjc.6603393
Bae, 2007, EGFR, ERBB2, and KRAS mutations in Korean non-small cell lung cancer patients, Cancer Genet Cytogenet, 173, 107, 10.1016/j.cancergencyto.2006.10.007
Haneda, 2006, A correlation between EGFR gene mutation status and bronchioloalveolar carcinoma features in Japanese patients with adenocarcinoma, Jpn J Clin Oncol, 36, 69, 10.1093/jjco/hyi228
Riely, 2006, Clinical course of patients with non-small cell lung cancer and epidermal growth factor receptor exon 19 and exon 21 mutations treated with gefitinib or erlotinib, Clin Cancer Res, 12, 839, 10.1158/1078-0432.CCR-05-1846
Sugio, 2009, Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations, Lung Cancer, 64, 314, 10.1016/j.lungcan.2008.09.010
Sunaga, 2007, Phase II prospective study of the efficacy of gefitinib for the treatment of stage III/IV non-small cell lung cancer with EGFR mutations, irrespective of previous chemotherapy, Lung Cancer, 56, 383, 10.1016/j.lungcan.2007.01.025
Tang, 2008, Epidermal growth factor receptor abnormalities in the pathogenesis and progression of lung adenocarcinomas, Cancer Prev Res (Phila), 1, 192, 10.1158/1940-6207.CAPR-08-0032
Cote, 2011, Frequency and type of epidermal growth factor receptor mutations in African Americans with non-small cell lung cancer, J Thorac Oncol, 6, 627, 10.1097/JTO.0b013e31820a0ec0
Moiseyenko, 2010, High efficacy of first-line gefitinib in non-Asian patients with EGFR-mutated lung adenocarcinoma, Onkologie, 33, 231, 10.1159/000302729
Sahoo, 2011, Screening for EGFR mutations in lung cancer, a report from India, Lung Cancer, 73, 316, 10.1016/j.lungcan.2011.01.004
Otani, 2008, Detection of EGFR gene mutations using the wash fluid of CT-guided biopsy needle in NSCLC patients, J Thorac Oncol, 3, 472, 10.1097/JTO.0b013e31816de2cd
Dacic, 2010, Clinicopathological predictors of EGFR/KRAS mutational status in primary lung adenocarcinomas, Mod Pathol, 23, 159, 10.1038/modpathol.2009.154
Boland, 2009, Anaplastic lymphoma kinase immunoreactivity correlates with ALK gene rearrangement and transcriptional up-regulation in non-small cell lung carcinomas, Hum Pathol, 40, 1152, 10.1016/j.humpath.2009.01.012
Kwak, 2010, Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer, N Engl J Med, 363, 1693, 10.1056/NEJMoa1006448
Guerin, 2015, ALK rearrangement testing and treatment patterns for patients with ALK-positive non-small cell lung cancer, Cancer Epidemiol, 39, 307, 10.1016/j.canep.2015.04.005
Hata, 2013, Rebiopsy of non-small cell lung cancer patients with acquired resistance to epidermal growth factor receptor-tyrosine kinase inhibitor: Comparison between T790M mutation-positive and mutation-negative populations, Cancer, 119, 4325, 10.1002/cncr.28364
Sun, 2013, Clinical implications of T790M mutation in patients with acquired resistance to EGFR tyrosine kinase inhibitors, Lung Cancer, 82, 294, 10.1016/j.lungcan.2013.08.023
Janjigian, 2014, Dual inhibition of EGFR with afatinib and cetuximab in kinase inhibitor-resistant EGFR-mutant lung cancer with and without T790M mutations, Cancer Discov, 4, 1036, 10.1158/2159-8290.CD-14-0326
Janne, 2015, AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer, N Engl J Med, 372, 1689, 10.1056/NEJMoa1411817
Ding, 2014, The predictive role of pretreatment epidermal growth factor receptor T790M mutation on the progression-free survival of tyrosine-kinase inhibitor-treated non-small cell lung cancer patients: a meta-analysis, Onco Targets Ther, 7, 387
Cross, 2014, AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer, Cancer Discov, 4, 1046, 10.1158/2159-8290.CD-14-0337
Politi, 2015, The next wave of EGFR tyrosine kinase inhibitors enter the clinic, Cancer Cell, 27, 751, 10.1016/j.ccell.2015.05.012
Chmielecki, 2011, Optimization of dosing for EGFR-mutant non-small cell lung cancer with evolutionary cancer modeling, Sci Transl Med, 3
Bean, 2007, MET amplification occurs with or without T790M mutations in EGFR mutant lung tumors with acquired resistance to gefitinib or erlotinib, Proc Natl Acad Sci U S A, 104, 20932, 10.1073/pnas.0710370104
Engelman, 2006, Allelic dilution obscures detection of a biologically significant resistance mutation in EGFR-amplified lung cancer, J Clin Invest, 116, 2695, 10.1172/JCI28656
Thress, 2015, EGFR mutation detection in ctDNA from NSCLC patient plasma: a cross-platform comparison of leading technologies to support the clinical development of AZD9291, Lung Cancer, 90, 509, 10.1016/j.lungcan.2015.10.004
Kim, 2015, Mechanisms of acquired resistance to AZD9291: a mutation-selective, irreversible EGFR inhibitor, J Thorac Oncol, 10, 1736, 10.1097/JTO.0000000000000688
Yu, 2015, Acquired resistance of EGFR-mutant lung cancer to a T790M-specific EGFR inhibitor: emergence of a third mutation (C797S) in the EGFR tyrosine kinase domain, JAMA Oncol, 1, 982, 10.1001/jamaoncol.2015.1066
cobas® EGFR Mutation Test v2 [package insert]. Branchburg, NJ: Roche Molecular Systems Inc;2015.
Oxnard, 2014, Noninvasive detection of response and resistance in EGFR-mutant lung cancer using quantitative next-generation genotyping of cell-free plasma DNA, Clin Cancer Res, 20, 1698, 10.1158/1078-0432.CCR-13-2482
Wei, 2016, Circulating DNA addresses cancer monitoring in non small cell lung cancer patients for detection and capturing the dynamic changes of the disease, Springerplus, 5, 531, 10.1186/s40064-016-2141-5
Kukita, 2013, Quantitative identification of mutant alleles derived from lung cancer in plasma cell-free DNA via anomaly detection using deep sequencing data, PLoS One, 8, e81468, 10.1371/journal.pone.0081468
Mok, 2015, Detection and dynamic changes of EGFR mutations from circulating tumor DNA as a predictor of survival outcomes in NSCLC patients treated with first-line intercalated erlotinib and chemotherapy, Clin Cancer Res, 21, 3196, 10.1158/1078-0432.CCR-14-2594
Oxnard, 2016, Association between plasma genotyping and outcomes of treatment with osimertinib (AZD9291) in advanced non-small-cell lung cancer, J Clin Oncol, 34, 3375, 10.1200/JCO.2016.66.7162
Wang, 2016, C797S mutation mediates resistance to third-generation inhibitors in T790M-positive non-small cell lung cancer, J Hematol Oncol, 9, 59, 10.1186/s13045-016-0290-1
Huang, 2013, Multiplexed deep sequencing analysis of ALK kinase domain identifies resistance mutations in relapsed patients following crizotinib treatment, Genomics, 102, 157, 10.1016/j.ygeno.2013.02.006
Douillard, 2010, Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial, J Clin Oncol, 28, 744, 10.1200/JCO.2009.24.3030
Schwarzenbach, 2011, Cell-free nucleic acids as biomarkers in cancer patients, Nat Rev Cancer, 11, 426, 10.1038/nrc3066
Bettegowda, 2014, Detection of circulating tumor DNA in early- and late-stage human malignancies, Sci Transl Med, 6, 10.1126/scitranslmed.3007094
Douillard, 2014, Gefitinib treatment in EGFR mutated Caucasian NSCLC: circulating-free tumor DNA as a surrogate for determination of EGFR status, J Thorac Oncol, 9, 1345, 10.1097/JTO.0000000000000263
Li, 2014, Insufficiency of peripheral blood as a substitute tissue for detecting EGFR mutations in lung cancer: a meta-analysis, Targeted Oncology, 9, 381, 10.1007/s11523-014-0312-2
Jiang, 2015, Lengthening and shortening of plasma DNA in hepatocellular carcinoma patients, Proc Natl Acad Sci U S A, 112, E1317, 10.1073/pnas.1500076112
Mouliere, 2011, High fragmentation characterizes tumour-derived circulating DNA, PLoS One, 6, e23418, 10.1371/journal.pone.0023418
Wang, 2003, Increased plasma DNA integrity in cancer patients, Cancer Res, 63, 3966
Luo, 2014, Diagnostic value of circulating free DNA for the detection of EGFR mutation status in NSCLC: a systematic review and meta-analysis, Sci Rep, 4, 6269, 10.1038/srep06269
Sakai, 2013, Detection of epidermal growth factor receptor T790M mutation in plasma DNA from patients refractory to epidermal growth factor receptor tyrosine kinase inhibitor, Cancer Sci, 104, 1198, 10.1111/cas.12211
Wang, 2014, Quantification and dynamic monitoring of EGFR T790M in plasma cell-free DNA by digital PCR for prognosis of EGFR-TKI treatment in advanced NSCLC, PLoS One, 9, e110780, 10.1371/journal.pone.0110780
Rittmeyer, 2017, Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial, Lancet, 389, 255, 10.1016/S0140-6736(16)32517-X
Herbst, 2016, Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial, Lancet, 387, 1540, 10.1016/S0140-6736(15)01281-7
Reck, 2016, Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer, N Engl J Med, 375, 1823, 10.1056/NEJMoa1606774
Borghaei, 2015, Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer, N Engl J Med, 373, 1627, 10.1056/NEJMoa1507643
Brahmer, 2015, Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer, N Engl J Med, 373, 123, 10.1056/NEJMoa1504627
2015, FDA approves KEYTRUDA for advanced non-small cell lung cancer, [press release]
2015, FDA expands approved use of Opdivo in advanced lung cancer, [news release]
US Food and Drug Administration, 2017, Atezolizumab (TECENTRIQ). US Food and Drug Administration Web site
Sholl, 2016, Programmed death ligand-1 immunohistochemistry—a new challenge for pathologists: a perspective from members of the Pulmonary Pathology Society, Arch Pathol Lab Med, 140, 341, 10.5858/arpa.2015-0506-SA
KEYTRUDA [package insert]. Whitehouse Station, NJ: Merck & Co, Inc; 2014.
OPDIVO [package insert]. Princeton, NJ: Bristol-Myers Squibb Company;2015.
TECENTRIQ [package insert]. South San Francisco, CA: Genentech, Inc; 2016.
Balshem, 2011, GRADE guidelines, 3: rating the quality of evidence, J Clin Epidemiol, 64, 401, 10.1016/j.jclinepi.2010.07.015