Abstract
The advent of next-generation sequencing (NGS), including both tissue assays and circulating
tumor DNA (ct-DNA), has been pivotal in improving outcomes for patients with non-small
cell lung cancer (NSCLC). Although molecular testing is standard of care for advanced
NSCLC, challenges still exist in its implementation. This Perspective examines barriers
to the widespread implementation of NGS from the vantage point of a single urban safety-net
institution, with a particular focus on examining racial disparities in NGS completion.
We conducted a review of patients at our institution from January 2015 through January
2022 and examined molecular testing patterns before and after the publication of updated
molecular testing guidelines from the International Association for the Study of Lung
Cancer (IASLC), Association for Molecular Pathology (AMP), and College of American
Pathologists (CAP) in March of 2018. While NGS increased over time, we found that
43% of patients in the March 2018 through January 2022 group still did not receive
NGS, and the most common reasons for the absence of testing included a lack of physician
ordering and insufficient tissue on biopsy. We did not note any racial disparities
in completion or time-to-adoption of NGS. Patients with squamous cell carcinoma (SCC)
histology were noted to receive liquid NGS markedly less often than patients with
non-squamous histology in the March 2018 through January 2022 period. Based on our
own data and a review of findings from colleagues in the field, we advocate for additional
physician educational programming, increased use of ct-DNA biopsy, automated (reflexive)
NGS tissue testing on receipt of biopsy, and consideration for the broader molecular
profiling of patients with SCC histology.
Keywords
To read this article in full you will need to make a payment
Purchase one-time access:
Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online accessOne-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:
Subscribe to Clinical Lung CancerAlready a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
References
- ASCO provisional clinical opinion: epidermal growth factor receptor mutation testing in practice.J Oncol Pract. 2011; 7: 202-204
- A systematic review and Canadian consensus recommendations on the use of biomarkers in the treatment of non-small cell lung cancer.J Thorac Oncol. 2011; 6: 1379-1391https://doi.org/10.1097/JTO.0b013e318220cb8e
- 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. 2013; 8: 823-859
- Molecular testing guideline for the selection of patients with lung cancer for treatment with targeted 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 clinical practice guideline update.J Clin Oncol. 2018; 36: 911-919
- What is next generation sequencing?.Arch Dis Child Educ Pract Ed. 2013; 98: 236-238https://doi.org/10.1136/archdischild-2013-304340
- Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted Tyrosine Kinase Inhibitors: guideline from the college of American Pathologists, the international Association for the study of lung cancer, and the Association for Molecular Pathology.J Thorac Oncol. 2018; 13: 323-358https://doi.org/10.1016/j.jtho.2017.12.001
National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology. non-small cell lung cancer., 2022.
- Highly sensitive and quantitative test platform for detection of NSCLC EGFR mutations in urine and plasma.J. Thorac. Oncol. 2016; 11: 1690-1700
- Implementing ctDNA analysis in the clinic: challenges and opportunities in non-small Cell Lung Cancer.Cancers (Basel). 2020; 12: 3112https://doi.org/10.3390/cancers12113112
- Pan-Asian adapted clinical practice guidelines for the management of patients with metastatic non-small cell lung cancer; a CSCO-ESMO initiative endorsed by JSMO, KSMO, MOS, SSO and TOS.Ann Oncol. 2019; 30: 171-210
- Biomarker testing for patients with advanced non-small cell lung cancer: real-world issues and tough choices.Am Soc Clin Oncol Educ Book. 2019; 39: 531-542https://doi.org/10.1200/EDBK_237863
- Real-world patterns of EGFR testing and treatment with erlotinib for non-small cell lung cancer in theU.S.PLoS One. 2016; 11e0156728https://doi.org/10.1371/journal.pone.0156728
- Sociodemographic disparities in the management of advanced lung cancer: a narrative review.J Thorac Dis. 2021; 13: 3772-3800https://doi.org/10.21037/jtd-20-3450
- Cancer health disparities in racial/ethnic minorities in theU.S.Br J Cancer. 2021; 124: 315-332https://doi.org/10.1038/s41416-020-01038-6
- Analysis of racial/ethnic representation in select basic and applied cancer research studies.Sci Rep. 2018; 8: 13978https://doi.org/10.1038/s41598-018-32264-x
- Racial and insurance-related disparities in delivery of immunotherapy-type compounds in theU.S.J Immunother. 2019; 42: 55-64https://doi.org/10.1097/CJI.0000000000000253
- Racial disparities and treatment trends in a large cohort of elderly black and white patients with nonsmall cell lung cancer.Cancer. 2009; 115: 2199-2211https://doi.org/10.1002/cncr.24248
- Boston Medical Center Race and Ethnicity Profiles: Calendar Year.2009
- Disparities in Lung Cancer Treatment [published online ahead of print, 2022 Jan 26].Curr Oncol Rep. 2022; https://doi.org/10.1007/s11912-022-01193-4
- Racial disparities in biomarker testing and clinical trial enrollment in non-small cell lung cancer (NSCLC).J Clin Oncol. 2021; 39: 9005
- Improving care for patients with stage III or IV NSCLC: learnings form multidisciplinary teams from the ACCC National Quality Survey.JCO Oncol Pract. 2021; 17: e1120-e1130https://doi.org/10.1200/OP.20.0089
- Trends in use of next-generation sequencing in patients with solid tumors by race and ethnicity after implementation of the medicare National Coverage Determination.JAMA Netw Open. 2021; 4e2138219https://doi.org/10.1001/jamanetworkopen.2021.38219
- Trends in molecular testing of lung cancer in mainland eople's Republic of China over the decade 2010 to 2019.JTO Clin Res Rep. 2021; 2100163https://doi.org/10.1016/j.jtocrr.2021.100163
- Genomic testing among patients with newly diagnosed advanced non-small cell lung cancer in theU.S.: acontemporary clinical practice patterns study.Lung Cancer. 2022; https://doi.org/10.1016/j.lungcan.2022.01.021
- Biomarker testing and tissue journey among patients with metastatic non-small cell lung cancer receiving first-line therapy in The US Oncology Network Biomarker testing in metastatic NSCLC with first-line therapy.Lung Cancer. 2022;
- The International Association for the study of lung cancer global survey on molecular testing in lung cancer.J Thorac Oncol. 2020; 15: 1434-1448https://doi.org/10.1016/j.jtho.2020.05.002
Center for Health and Information Analysis of Massachusetts. Boston Medical Center 2017 hospital profile. https://www.chiamass.gov/assets/docs/r/hospital-profiles/2017/bmc.pdf. 2017. Accessed January 29 2022.
Center for Medicare and Medicaid Services: CMS finalizes coverage of next generation sequencing tests, ensuring enhanced access for cancer patients. https://www.cms.gov/newsroom/press-releases/cms-finalizes-coverage-next-generation-sequencing-tests-ensuring-enhanced-access-cancer-patients.
- Cost-effectiveness analysis comparing companion diagnostic tests for EGFR, ALK, and ROS1 vs.next-generation sequencing (NGS) in advanced adenocarcinoma lung cancer patients.BMC Cancer. 2020; 20: 875https://doi.org/10.1186/s12885-020-07240-2
- Cost effectiveness of multigene panel sequencing for patients with advanced non-small-cell lung cancer.JCO Clin Cancer Inform. 2019; 3: 1-10https://doi.org/10.1200/CCI.19.00002
Global next generation sequencing markets 2021-2028: rise in competition amongst prominent market entities- research and markets.com. www.businesswire.com. Published October 4, 2021. Accessed June 24, 2022. https://www.businesswire.com/news/home/20211004005472/en/Global-Next-Generation-Sequencing-Markets-2021-2028-Rise-in-Competition-Amongst-Prominent-Market-Entities—ResearchAndMarkets.com.
- Reflex testing in non-small cell lung carcinoma using DNA- and RNA-based next-generation sequencing-a single-center experience.Transl Lung Cancer Res. 2021; 10: 4221-4234https://doi.org/10.21037/tlcr-21-570
- Genomic profiling of advanced non-small cell lung cancer in community settings: gaps and opportunities.Clin Lung Cancer. 2017; 18: 651-659https://doi.org/10.1016/j.cllc.2017.04.004
- Genomic testing in cancer: patient knowledge, attitudes, and expectations.Cancer. 2014; 120: 3066-3073https://doi.org/10.1002/cncr.28807
- Oncologists' and cancer patients' views on whole-exome sequencing and incidental findings: results from the CanSeq study.Genet Med. 2016; 18: 1011-1019https://doi.org/10.1038/gim.2015.207
- Next-generation sequencing and the clinical oncology workflow: data challenges, proposed solutions, and a call to action.JCO Precis Oncol. 2019; 3https://doi.org/10.1200/PO.19.00232
- Patients' and oncologists' knowledge and expectations regarding tumor multigene next-generation sequencing: a narrative review.Oncologist. 2021; 26: e1359-e1371https://doi.org/10.1002/onco.13783
- Practical implications of single-gene versus NGS testing in advanced NSCLC.J. Clin. Oncol. 2017; 35: e23106
- Diagnostic and economic value of biomarker testing for targetable mutations in non-small-cell lung cancer: a literature review.Future Oncol. 2022; 18: 505-518https://doi.org/10.2217/fon-2021-1040
- Utility of incorporating next-generation sequencing (NGS) in an Asian non-small cell lung cancer (NSCLC) population: incremental yield of actionable alterations and cost–effectiveness analysis.Lung Cancer. 2020;; 139: 207-215
- A model comparing the value of broad next-gen sequencing (NGS)-based testing to single gene testing (SGT) in patients with nonsquamous non-small cell lung cancer (NSCLC) in the United States.J Clin Oncol. 2020; 38: 9529https://doi.org/10.1200/JCO.2020.38.15_suppl.9529
- Liquid biopsy for advanced NSCLC: aconsensus statement from the international association for the study of Lung Cancer.J Thorac Oncol. 2021; 16: 1647-1662https://doi.org/10.1016/j.jtho.2021.06.017
- Genotype-Specific differences in circulating tumor DNA levels in advanced NSCLC.J Thorac Oncol. 2021; 16https://doi.org/10.1016/j.jtho.2020.12.011
- Molecular testing guideline for the selection of patients with lung cancer for treatment with targeted 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 olecular Pathology Clinical Practice Guideline update.J Clin Oncol. 2018; 36: 911-919https://doi.org/10.1200/JCO.2017.76.7293
- Molecular testing turnaround time for non-small cell lung cancer in routine clinical practice confirms feasibility of CAP/IASLC/AMP guideline recommendations: a single-center analysis.Clin Lung Cancer. 2017; 18: e349-e356https://doi.org/10.1016/j.cllc.2017.03.001
- A real-world application of liquid biopsy in metastatic colorectal cancer: the poseidon study.Cancers (Basel). 2021; 13: 5128https://doi.org/10.3390/cancers13205128
- Molecular testing strategies in non-small cell lung cancer: optimizing the diagnostic journey.Transl Lung Cancer Res. 2019; 8: 286-301https://doi.org/10.21037/tlcr.2019.04.14
- Next-generation sequencing informs diagnosis and identifies unexpected therapeutic targets in lung squamous cell carcinomas.Lung Cancer. 2020; 140: 35-41https://doi.org/10.1016/j.lungcan.2019.12.005
- Targeted tissue and cell-free tumor DNA sequencing of advanced lung squamous-cell carcinoma reveals clinically significant prevalence of actionable alterations.Clin Lung Cancer. 2019; 20: 30-36https://doi.org/10.1016/j.cllc.2018.08.020
- Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group.Ann Oncol. 2020; 31: 1491-1505https://doi.org/10.1016/j.annonc.2020.07.014
- Efficacy of epidermal growth factor receptor-tyrosine kinase inhibitors for Chinese patients with squamous cell carcinoma of lung harboring EGFR mutation.J Thorac Dis. 2013; 5: 585-592https://doi.org/10.3978/j.issn.2072-1439.2013.09.15
- EGFR-Mutated Squamous Cell Lung Cancer and its association with outcomes.Front Oncol. 2021; 11680804
Article info
Publication history
Published online: November 11, 2022
Accepted:
November 4,
2022
Received in revised form:
October 27,
2022
Received:
June 29,
2022
Identification
Copyright
© 2022 Elsevier Inc. All rights reserved.
