EGFR Exon 20 Insertion Mutations in Lung Adenocarcinomas: Prevalence, Molecular Heterogeneity, and Clinicopathologic Characteristics
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Abstract
In contrast to other primary epidermal growth factor receptor (EGFR) mutations in lung adenocarcinomas, insertions in exon 20 of EGFR have been generally associated with resistance to EGFR-tyrosine kinase inhibitors. Their molecular spectrum, clinicopathologic characteristics, and prevalence are not well established. Tumors harboring EGFR exon 20 insertions were identified through an algorithmic screen of 1,500 lung adenocarcinomas. Cases were first tested for common mutations in EGFR (exons 19 and 21) and KRAS (exon 2) and, if negative, further analyzed for EGFR exon 20 insertions. All samples underwent extended genotyping for other driver mutations in EGFR, KRAS, BRAF, ERBB2/HER2, NRAS, PIK3CA, MEK1, and AKT by mass spectrometry; a subset was evaluated for ALK rearrangements. We identified 33 EGFR exon 20 insertion cases [2.2%, 95% confidence interval (CI), 1.6-3.1], all mutually exclusive with mutations in the other genes tested (except PIK3CA). They were more common among never-smokers (P < 0.0001). There was no association with age, sex, race, or stage. Morphologically, tumors were similar to those with common EGFR mutations but with frequent solid histology. Insertions were highly variable in position and size, ranging from 3 to 12 bp, resulting in 13 different insertions, which, by molecular modeling, are predicted to have potentially different effects on erlotinib binding. EGFR exon 20 insertion testing identifies a distinct subset of lung adenocarcinomas, accounting for at least 9% of all EGFR-mutated cases, representing the third most common type of EGFR mutation after exon 19 deletions and L858R. Insertions are structurally heterogeneous with potential implications for response to EGFR inhibitors.
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EGFR exon 20 insertions are typically unresponsive to first- and second-generation EGFR TKIs due to modified structures of their kinase domains.
“they are typically unresponsive to first and second-generation EGFR TKIs due to the modified structures of their kinase domains”
From Diverse EGFR Exon 20 Insertions and Co-Occurring Molecular Alterations Identified by Comprehensive Genomic Profiling of NSCLC (2018) · cites this paper as [7]
Most exon 20 insertion mutations, except the rare A763_Y764insFQEA, make tumors resistant to the standard first-line EGFR inhibitors erlotinib, gefitinib, and afatinib.
“EGFR Ex20Ins tumors are generally unresponsive to 1st and 2nd generation EGFR inhibitors”
From Antitumor Activity of Osimertinib, an Irreversible Mutant-Selective EGFR Tyrosine Kinase Inhibitor, in NSCLC Harboring EGFR Exon 20 Insertions (2018) · cites this paper as [2]
The two most clinically prevalent Ex20Ins variants, SVD and ASV, are constitutively active in a manner analogous to canonical activating EGFR mutations.
“Our findings provide evidence that the two most clinically prevalent variants of Ex20Ins mutations, SVD (D770_N771InsSVD) and Ex20Ins ASV (V769_D770InsASV) (2,4,18), are constitutively active in an analogous manner to canonical activating-mutations.”
From Antitumor Activity of Osimertinib, an Irreversible Mutant-Selective EGFR Tyrosine Kinase Inhibitor, in NSCLC Harboring EGFR Exon 20 Insertions (2018) · cites this paper as [2]
The two most prevalent Ex20Ins forms, D770_N771InsSVD and V769_D770InsASV, account for approximately 40% of patients with Ex20Ins mutations.
“the two most prevalent forms of Ex20Ins (D770_N771InsSVD and V769_D770InsASV), which account for approximately 40% of such patients (2,4,18).”
From Antitumor Activity of Osimertinib, an Irreversible Mutant-Selective EGFR Tyrosine Kinase Inhibitor, in NSCLC Harboring EGFR Exon 20 Insertions (2018) · cites this paper as [2]
EGFR A763_Y764insFQEA accounts for 10-20% of all reported EGFR exon 20 insertions.
“This sequence alteration accounts for 10–20% of all reported EGFR exon 20 insertions 31,32,35.”
From Structural, Biochemical, and Clinical Characterization of Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations in Lung Cancer (2013) · cites this paper as [32]
The most common exon 20 insertions are post C-helix insertions of 1-4 amino acids, accounting for 80-90% of all exon 20 insertions.
“The most common EGFR exon 20 insertions that have been reported in NSCLC samples are post C-helix insertions of one to four amino-acids, which in aggregate account for 80–90% of all exon 20 insertions 31,32,35.”
From Structural, Biochemical, and Clinical Characterization of Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations in Lung Cancer (2013) · cites this paper as [32]
Several studies have shown that 1G EGFR-TKI are less effective in patients with NSCLC harboring uncommon EGFR mutations compared with patients harboring common EGFR mutations.
“Several studies, although very small, have shown that 1G EGFR‐TKI are less effective in patients with NSCLC harboring such uncommon EGFR mutations, compared with patients harboring common EGFR mutations.”
Many studies have shown that uncommon EGFR mutations are less sensitive to 1G EGFR-TKIs (objective response rate less than 50%) compared with common EGFR mutations.
“many studies have shown that these uncommon EGFR mutations were less sensitive to 1G EGFR‐TKI (objective response rate, less than 50%), compared with common EGFR mutations.18, 19, 20, 21, 22, 23, 24, 25, 26”
Considering these findings, afatinib might be optimal for patients with NSCLC harboring EGFR uncommon mutations including exon 18 mutations, L861Q and S768I in clinical settings.
“Considering these findings including our studies, 18, 19, 20, 21, 22, 23, 27, 28, 41 afatinib might be optimal for patients with NSCLC harboring the EGFR uncommon mutations including exon 18 mutations, L861Q and S768I in clinical settings.”
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- Authors
- Arcila, M. E., Nafa, K., Chaft, J. E., Rekhtman, N., Lau, C., Reva, B. A., Zakowski, M. F., Kris, M. G., & Ladanyi, M.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- Authors' Affiliations: 1Department of Pathology; 2Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine; 3Computational Biology Center; and 4Human Oncology and Pathogenesis Program, Memorial Sloan-Kettering Cancer Center, New York, New York
- Corresponding author
- Arcila, Maria E.
- ORCID
- Venue
- Molecular Cancer Therapeutics
- Published
- 2013-02-01
- Volume
- 12
- Issue
- 2
- Pages
- 220-229
- ISSN
- 1535-7163 (ISSN-L)
- 1538-8514
- PMC
- PMC3714231
- OpenAlex
- W2143863753
- Cited by
- 473
- References
- 38
- Citations by year
- 2026: 20 · 2025: 42 · 2024: 43 · 2023: 42 · 2022: 66 · 2021: 55 · 2020: 43 · 2019: 30 · 2018: 31 · 2017: 22 · 2016: 20 · 2015: 23 · 2014: 24 · 2013: 12
- FWCI
- 21.40
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Molecular Cancer Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Memorial Sloan-Kettering Cancer Center
- National Institutes of Health (UL1TR000457)
- National Cancer Institute (P01CA129243, NIH P01 CA129243)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Keywords
- EGFR exon 20 insertion, lung adenocarcinoma, EGFR tyrosine kinase inhibitors, erlotinib resistance, molecular heterogeneity, never smokers, driver mutations, PIK3CA, ALK rearrangement, clinicopathological features
- MeSH terms
- Adenocarcinoma of Lung, Adenocarcinoma, Adult, Aged, Aged, 80 and over, Exons, Female, Humans, Lung Neoplasms, Male, Middle Aged, Prevalence, Survival Analysis, Mutagenesis, Insertional, ErbB Receptors
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