State of the Art: Concise Review
Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer

https://doi.org/10.1016/j.jtho.2021.06.017Get rights and content
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Abstract

Although precision medicine has had a mixed impact on the clinical management of patients with advanced-stage cancer overall, for NSCLC, and more specifically for lung adenocarcinoma, the advances have been dramatic, largely owing to the genomic complexity and growing number of druggable oncogene drivers. Furthermore, although tumor tissue is historically the “accepted standard” biospecimen for these molecular analyses, there are considerable innate limitations. Thus, liquid biopsy represents a practical alternative source for investigating tumor-derived somatic alterations. Although data are most robust in NSCLC, patients with other cancer types may also benefit from this minimally invasive approach to facilitate selection of targeted therapies. The liquid biopsy approach includes a variety of methodologies for circulating analytes. From a clinical point of view, plasma circulating tumor DNA is the most extensively studied and widely adopted alternative to tissue tumor genotyping in solid tumors, including NSCLC, first entering clinical practice for detection of EGFR mutations in NSCLC. Since the publication of the first International Association for the Study of Lung Cancer (IASLC) liquid biopsy statement in 2018, several additional advances have been made in this field, leading to changes in the therapeutic decision-making algorithm for advanced NSCLC and prompting this 2021 update. In view of the novel and impressive technological advances made in the past few years, the growing clinical application of plasma-based, next-generation sequencing, and the recent Food and Drug and Administration approval in the United States of two different assays for circulating tumor DNA analysis, IASLC revisited the role of liquid biopsy in therapeutic decision-making in a recent workshop in October 2020 and the question of “plasma first” versus “tissue first” approach toward molecular testing for advanced NSCLC. Moreover, evidence-based recommendations from IASLC provide an international perspective on when to order which test and how to interpret the results. Here, we present updates and additional considerations to the previous statement article as a consensus from a multidisciplinary and international team of experts selected by IASLC.

Keywords

ctDNA
Liquid biopsy
IASLC
NSCLC
Oncogene addicted
Immunotherapy

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Disclosure: Dr. Rolfo reports grants from Pfizer and MSD, consulting fees from Archer, Inivata, BMS, Novartis, Boston Pharmaceuticals, MD Serono; other from AstraZeneca, Roche, GuardantHealth, and MSD; safety monitoring board for MD Serono; leadership roles with ISLB, IASLC, ESO and ESMO; other support from GuardantHealth. Dr. Scagliotti reports personal fees from Astrazeneca, personal fees from Roche, personal fees from Takeda, personal fees from Pfizer, personal fees from Beigene, personal fees from Eli Lilly, personal fees from MSD, personal fees from J&J, outside the submitted work. Dr. Aggarwal reports consulting fees from AstraZeneca, BMS, Celgene, Eli Lilly, Daichii, Bluprint, Merck, and Roche. Dr. Arcila reports consulting fees from Biocartis, Invivoscribe, AstraZeneca, Bristol-MyersSquibb; payment from Biocartis, Invivoscribe, PER - Physician education resource, PVR - Peerview institute for medical education; a leadership role with Association for Molecular Pathology. Dr. Barlesi reports consulting fees from Astra-Zeneca, Bayer, Bristol-Myers Squibb, Boehringer– Ingelheim, Eli Lilly Oncology, F. Hoffmann– La Roche Ltd, Novartis, Merck, Mirati, MSD, Pierre Fabre, Pfizer, Seattle Genetics and Takeda; other from Astra-Zeneca, Bayer, Bristol-Myers Squibb, Boehringer– Ingelheim, Eli Lilly Oncology, F. Hoffmann– La Roche Ltd, Novartis, Merck, Mirati, MSD, Pierre Fabre, Pfizer, Seattle Genetics and Takeda. Dr. Bivona reports support from NIH/NCI; grants from Novartis, Strategia, and Revolution Medicine; consulting fees from Revolution Medicine, Rain, Relay, Jazz, Novartis, Astrazeneca, Array/Pfizer, EcoR1, Springworks, and Guardant Health; participation on a data safety monitoring board for Beyondspring; other from Revolution Medicine, Relay, and Rain. Dr. Diehn reports grants from NIH, SU2C, TRDRP, Varian, and AstraZeneca; other from Roche; consulting fees from AstraZeneca, Roche, Genentech, Novartis, Gritstone Oncology, BioNTech, Boehringer Ingelheim, Illumina; travel support from AstraZeneca and RefeXion; multiple patents on cancer biomarkers Stanford University; leadership role at Foresight Diagnostics; other from Foresight Diagnostics and CiberMed; other from Illumina. Dr. Dive reports grants and personal fees from AstraZeneca, grants from Astex Pharmaceuticals, grants from Bioven, grants from Amgen, grants from Carrick Therapeutics, grants and personal fees from Merck AG, grants from Taiho Oncology, grants from GSK, grants from Bayer, grants from Boehringer Ingelheim, grants from Roche, grants from BMS, grants from Novartis, grants from Celgene, grants from Epigene Therapeutics Inc, grants from Angle PLC, grants from Menarini, grants from Clearbridge Biomedics, grants from Merck, personal fees from Biocartis, non-financial support from Thermo Fisher Scientific, outside the submitted work. Dr. Dziadziuszko reports other from AstraZeneca, Roche, Novaris, Pfizer, MSD, Bristol-Myers Squibb, SeattleGenetics, Takeda, FoundationMedicine, and Amgen; travel support from AstraZeneca and Roche. Dr. Leighl reports other from Guardant Health and Roche, outside the submitted work; and travel funding from Teva Oncotest. Dr. Malapelle reports personal fees from Boehringer Ingelheim, personal fees from AstraZeneca, personal fees from Roche, personal fees from MSD, personal fees from Amgen, personal fees from Merck, personal fees from BMS, personal fees from Thermofisher, personal fees from Boehringer Ingelheim, personal fees from MSD, personal fees from Amgen, personal fees from Merck, personal fees from BMS, personal fees from Thermofisher, grants from Boehringer Ingelheim, grants from Amgen, during the conduct of the study. Dr. Mok reports personal fees from Abbvie, Inc., personal fees and other from ACEA Pharma, personal fees and other from Alpha Biopharma Co. Ltd., personal fees and other from Amgen, personal fees and other from Amoy Diagnostics Co. Ltd., grants, personal fees and other from AstraZeneca, personal fees and other from BeiGene, personal fees and other from Boehringer Ingelheim, grants, personal fees and other from Bristol-Myers Squibb, personal fees and other from Blueprint Medicines Corporation, personal fees and other from CStone Pharmaceuticals, personal fees and other from Daiichi Sankyo, personal fees and other from Eisai, personal fees and other from Fishawack Facilitate Ltd., other from geneDecode, personal fees and other from Gritstone Oncology Inc., personal fees and other from Guardant Health, personal fees and other from Hengrui Therapeutics, personal fees and other from Ignyta Inc., personal fees and other from IQVIA, personal fees and other from Incyte Corporation, personal fees from InMed Medical Communication, personal fees and other from Janssen, personal fees and other from Lilly, personal fees and other from Loxo-Oncology, personal fees and other from Lunit USA, Inc., personal fees from MD Health (Brazil), personal fees from Medscape/WebMD, grants, personal fees and other from Merck Serono, grants, personal fees and other from Merck Sharp & Dohme, personal fees and other from Mirati Therapeutics Inc., personal fees from MoreHealth, grants, personal fees and other from Novartis, personal fees and other from OrigiMed, personal fees from PeerVoice, personal fees from Physicians' Education Resource, personal fees from P. Permanyer SL, grants, personal fees and other from Pfizer, Inc, personal fees from PrIME Oncology, personal fees and other from Puma Technology Inc, personal fees from Research to Practice, grants, personal fees and other from Roche, personal fees and other from Sanofi-Aventis R&D, personal fees and other from Takeda, personal fees from Touch Medical Media, other from Virtus Medical Group, personal fees and other from Yuhan Corporation, other from AstraZeneca PLC, other from Hutchison Chi-Med, other from Sanomics Ltd., grants from Clovis Oncology, grants from SFJ Pharmaceuticals, grants from XCovery, personal fees from Curio Science , personal fees from Inivata, personal fees from Berry Oncology, grants and personal fees from G1 Therapeutics Inc., other from Aurora, personal fees from Qiming Development (HK) Ltd., outside the submitted work. Dr. Raez reports other from BMS. Loxo, Lilly Oncology, BMS, Pfizer, Novartis, AstraZeneca, Genentech, Syndax, Merck, and Nanth Health. Dr. Sequist reports grants and personal fees from AstraZeneca, grants from Novartis, grants and personal fees from Genentech, grants from Boehringer Ingelheim, personal fees from Janssen, grants from LOXO, outside the submitted work. Dr. Sholl reports grant payments to her institution from Genentech and consulting fees to her institution from Genentech; consulting fees from AstraZeneca and EMD Serono; and advisory board payment from LOXO Oncology. Dr. Swanton reports support from Francis Crick Institute and Royal Society support to his institution; grants to his institution from BMS, Ono Pharmaceuticals, Ooehringer-Ingelheim, Roche-Ventana, Archer Dx, and Pfizer; consulting fees from Genentech, Sarah Canon Research Institute, Medicxi, Bicycle Therapeutics, and GRAIL; other from Amgen, AstraZeneca, BMS, Illumina, GlaxoSmithKline, MSD, and Roche-Ventana, patents issued: PCT/US2017/028013, PCT/EP2016/071471, PCT/GB2017/053289, PCT/EP2016/059401, PCT/GB2018/051893, PCT/GB2018/051892, PCT/GB2018/052004, PCT/GB2018/)051912, PCT/GB2020/050221; part-time paid at Cancer Research UK, Board of Directors of AACR; stock and stock options Apogen Biotech, Epic Biosciences, GRAIL, Achilles Therapeutics, and other from AstraZeneca. Dr. Abbosh reports a fellowship grant from AstraZeneca, other from AstraZeneca and Bristol Myers Squib and two patents, Methods of detecting tumor recurrence (US Patent App.16/347,134, 2020) Methods for lung cancer detection (WO2017181202A2). Dr. Tan reports institutional grants from Novartis, AstraZeneca and Amgen; consulting fees from Janssen, Amgen, AstraZeneca, Boehringer Ingelheim, Bayer, Novartis, and Pfizer; advisory board for Novartis and BMS. Dr. Wakelee reports research funding to her institution from ACEA Biosciences, Arrys Therapeutics, AstraZeneca/Medimmune, BMS, Celgene, Clovis Oncology, Exelixis, Genentech/Roche, Gilead, Merck, Novartis, Pharmacyclics, Sea Gen, and Xcovery; honoraria from AstraZeneca; compensation for participation on an advisory board from AstraZeneca, Xcovery, Janssen, Daiichi Sankyo, Blueprint, Mirati, and Helsinn; participation on advisory boards without compensation from Merck and Genentech/Roche; leadership roles in IASLC and ECOG-ACRIN. Dr. Wistuba reports payments from Genentech/Roche, Bayer, Bristol-Myers Squibb, AstraZeneca/Medimmune, Pfizer, HTG Molecular, Merck, GlaxoSmithKline, Guardant Health, MSD, Flame, and Oncocyte; payments to his institution from Genentech, Akoya, Pfizer, Novartis, Johnson & Johnson, Karus, 4D, Iovance, EMD Serono, Amgen, Bayer, Takeda, Adaptimmune, Adaptive, AstraZeneca/Medimmune, Bristol-Myers Squibb, HTG Molecular, and Merck; other from Daiichi Sankyo, Pfizer, Roche, and AstraZeneca. Dr. Mitsudomi reports personal fees from ThermoFisher, personal fees from Guardant Health, during the conduct of the study; grants and personal fees from Boehringer-Ingeleheim, grants and personal fees from Chugai, grants and personal fees from Ono, personal fees from BMS, grants and personal fees from MSD, personal fees from Pfizer, grants and personal fees from Taiho, personal fees from Amgen, personal fees from Novartis, personal fees from Merck Biopharma, personal fees from Takeda, personal fees from Ddaiichi-Sankyo, grants and personal fees from AstraZeneca, personal fees from Eli-Lilly, outside the submitted work. Dr. Gandara reports a research grant from LCRF Pfizer, Advisory board activity: Archer, Inivata, MD Serono, Novartis, BMS; payment to his institution from AstraZeneca; research collaborations with Guardant Health. The remaining authors declare no conflict of interest.