Pooled analysis of the prognostic and predictive value of KRAS mutation status and mutation subtype in patients with non-small cell lung cancer treated with epidermal growth factor receptor tyrosine kinase inhibitors
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Objectives This pooled analysis of four trials of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKIs) versus placebo was conducted to clarify the prognostic and predictive roles of Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations (MUTs) and to explore the importance of MUT subtype.Methods Data were pooled from four trials of EGFR TKIs versus placebo (National Cancer Institute of Canada Clinical Trials Group [NCIC CTG] trial BR.21, TOPICAL, NCIC CTG trial BR.26, and NCIC CTG trial BR.19). Analyses of the combined data were performed to determine relationships of MUT status/subtype to response and survival end points.Results KRAS status was known for 1362 of 2624 patients (785 receiving EGFR TKIs and 577 receiving placebo); 275 (20%) had KRAS MUTs (248 at codon 12; 15 at codon 13; 12 at other codons). In the placebo arms there was no difference in overall survival (OS) for patients with KRAS MUTs or wild-type tumors (hazard ratio [HR] = 1.04, confidence interval [CI]: 0.81-1.33 for univariable analysis and HR = 1.09, CI: 0.85-1.41 for multivariable analysis). Patients with guanine-to-thymidine transversion MUTs had longer OS than did those with guanine-to-adenine transition MUTs or guanine-to-cytosine transversion MUTs (median OS 6.3, 1.8, and 3.9 months, respectively, p = 0.01). Patients with KRAS MUT tumors derived no benefit from EGFR TKIs (OS HR = 1.13, CI: 0.85-1.51; progression-free survival HR = 1.02, CI: 0.76-1.36). The interaction between KRAS status and EGFR TKI effect was significant for progression-free survival (p = 0.04) but not for OS (p = 0.17). For patients with G12V MUTs, EGFR TKI treatment was harmful (OS HR = 1.96, CI: 1.03-3.70, p = 0.04), whereas guanine-to-adenine transition MUTs were associated with an OS benefit from EGFR TKIs (HR = 0.49, CI: 0.24-1.00, p = 0.05).Conclusions Overall, KRAS MUT is neither prognostic nor predictive of benefit from EGFR TKIs. However, it appears that KRAS MUT subtypes are not homogeneous in terms of their prognostic and predictive effects. These observations require prospective validation.
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There is growing evidence that KRAS-mutated lung cancer does not represent a homogeneous NSCLC subgroup.
“According to recent molecular findings, there is growing evidence that KRASmutated lung cancer does not represent a homogeneous NSCLC subgroup.15,22,39,40”
From K-ras Mutation Subtypes in NSCLC and Associated Co-occuring Mutations in Other Oncogenic Pathways (2019) · cites this paper as [39]
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Zhang, Y., Ma, Y., Zhang, K., Wang, Y., Sun, X., Kan, C., & Han, F. (2025) · American Journal of Clinical Oncology · doi:10.1097/coc.0000000000001192 · Cited by 2 · see citing works
KRAS mutation subtypes in metastatic non-small cell lung cancer
AYTAÇ, A. (2025) · American Journal of Cancer Research · doi:10.62347/gyht4724 · Cited by 2 · see citing works
Molecular Testing in Lung Cancer
Mascaux, C., Tsao, M., & Hirsch, F. R. (2018) · Elsevier eBooks · doi:10.1016/b978-0-323-52357-8.00018-4 · Cited by 2 · see citing works
Prognostic and Predictive Value of KRAS Mutation in NSCLC
Yamamoto, S., Washington, L., & Komiya, T. (2016) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2016.04.035 · Cited by 1 · see citing works
Zer, A., Tsao, M., & Shepherd, F. A. (2016) · Journal of Thoracic Oncology · doi:10.1016/j.jtho.2016.08.130
Hirji, S. A., & D’Amico, T. A. (2018) · Journal of Thoracic Disease · doi:10.21037/jtd.2018.08.116
Genomic Alterations of KRAS and NRAS in B&H Colorectal and Non-small Cell Lung Cancer Patients
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A proteomic approach for understanding the metabolic adaptations in non-small cell lung cancer
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- Authors
- Zer, A., Ding, K., Lee, S. M., Goss, G. D., Seymour, L., Ellis, P. M., Hackshaw, A., Bradbury, P. A., Han, L., O’Callaghan, C. J., Tsao, M.-S., & Shepherd, F. A.
- Affiliations
- Princess Margaret Cancer Centre (CA)
- Queen's University (CA)
- University College London (GB)
- University of Ottawa (CA)
- Juravinski Cancer Centre (CA)
- Cancer Research UK (GB)
- Corresponding author
- Zer, Alona
- ORCID
- Venue
- Journal of Thoracic Oncology
- Publisher
- Elsevier BV
- Published
- 2016-03
- Volume
- 11
- Issue
- 3
- Pages
- 312-323
- ISSN
- 1556-0864 (ISSN-L)
- OpenAlex
- W2271051170
- Cited by
- 56
- References
- 32
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 3 · 2023: 3 · 2022: 4 · 2021: 11 · 2020: 10 · 2019: 4 · 2018: 7 · 2017: 4 · 2016: 6
- FWCI
- 4.48
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Thoracic Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Cancer Research UK
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
- Keywords
- KRAS mutation, non-small cell lung cancer, EGFR tyrosine kinase inhibitors, predictive biomarkers, prognostic factors, codon 12 mutation, G12V mutation, G12D mutation, overall survival, progression-free survival, treatment response, drug resistance, pooled analysis of clinical trials
- MeSH terms
- Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Prognosis, Randomized Controlled Trials as Topic, Proto-Oncogene Proteins p21(ras), Protein Kinase Inhibitors, ErbB Receptors
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