Outcomes in patients with non-small-cell lung cancer and acquired Thr790Met mutation treated with osimertinib: a genomic study

Lin, Chia-Chi; Shih, Jin-Yuan; Yu, Chong-Jen; Ho, Chao-Chi; Liao, Wei-Yu; Lee, Jih-Hsing; Tsai, Tzu-Hsiu; Su, Kang-Yi; Hsieh, Min-Shu; Chang, Yih-Leong; Bai, Ya-Ying; Huang, Derek De-Rui; Thress, Kenneth S; Yang, James Chih-Hsin

doi:10.1016/s2213-2600(17)30480-0

Cited by 146Lung Cancer Treatments and MutationsHER2/EGFR in Cancer ResearchLung Cancer Diagnosis and Treatment

Outcomes in patients with non-small-cell lung cancer and acquired Thr790Met mutation treated with osimertinib: a genomic study

Lin, Chia-Chi, Shih, Jin-Yuan, Yu, Chong-Jen, Ho, Chao-Chi, Liao, Wei-Yu, Lee, Jih-Hsing, Tsai, Tzu-Hsiu, Su, Kang-Yi +6 more·2018·The Lancet Respiratory Medicine

DOI 10.1016/s2213-2600(17)30480-0

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Abstract

Background Osimertinib is approved for the treatment of non-small-cell lung cancer in patients who develop the EGFR Thr790Met mutation after treatment with epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitors (TKIs). We assessed outcomes in patients with non-small-cell lung cancer and the EGFR Thr790Met mutation who were treated with osimertinib, a third-generation EGFR TKI, after previous treatment failure with one or more other EGFR TKIs.Methods Eligible patients had been enrolled at one centre in the AURA study, had shown resistance to a previous EGFR TKI, and had EGFR-activating mutations and acquired Thr790Met mutation detectable in tumour tissue or plasma. Patients took 20-240 mg osimertinib per day until disease progression or development of intolerable side-effects. Plasma samples were collected every 6 weeks and tumour tissue biopsy was done at study entry and was optional after disease progression. We tested samples for resistance mechanisms, including EGFR-activating, Thr790Met, and Cys797Ser mutations, and assessed associations with overall survival, progression-free survival, and survival after disease progression.Findings Of 71 patients enrolled in AURA, 53 were eligible for this analysis. Median progression-free survival was 11·1 months (95% CI 8·4-13·9) and overall survival was 16·9 months (11·7-29·1). 47 patients had disease progression. Median overall survival after osimertinib progression was 5·4 months (95% CI 4·1-10·0). Plasma samples were available for 40 patients after disease progression. 12 (30%) of these had the Thr790Met mutation (four of whom also had Cys797Ser mutations). Patients without detectable EGFR-activating mutations in plasma before treatment had the best overall and post-progression survival (22·4 months, 95% CI 15·6-not reached, and 10·8 months, 7·2-not reached, respectively). Loss of the Thr790Met mutation but presence of EGFR-activating mutations in plasma were associated with the shortest progression-free survival (median 2·6 months, 95% CI 1·3-not reached). In 22 post-progression tumour samples, we found one squamous cell and two small-cell transformations. We detected Thr790Met in nine (50%) of 18 samples, Cys797Ser in two (17%) of 12, cMET amplification in five (50%) of ten, BRAF mutation in one (8%) of 13, and KRAS mutation in one (8%) of 13.Interpretation Heterogeneous resistance mechanisms developed in patients receiving osimertinib. Differences in resistance mechanisms might dictate future development strategies for osimertinib in clinical trials.Funding AstraZeneca, Taiwan Ministry of Science and Technology.

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A subset of cases lost T790M at progression.
“Most recently, several groups reported that a subset of cases lost T790M at the time of progression[6, 12–14]”
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Authors: Lin, C.-C., Shih, J.-Y., Yu, C.-J., Ho, C.-C., Liao, W.-Y., Lee, J.-H., Tsai, T.-H., Su, K.-Y., Hsieh, M.-S., Chang, Y.-L., Bai, Y.-Y., Huang, D. D.-R., Thress, K. S., & Yang, J. C.-H.
Affiliations: National Taiwan University Hospital (TW)
National Taiwan University (TW)
AstraZeneca (United States) (US)
Corresponding author: Yang, James Chih-Hsin
ORCID: Lin, Chia-Chi
Shih, Jin-Yuan
Yu, Chong-Jen
Ho, Chao-Chi
Liao, Wei-Yu
Tsai, Tzu-Hsiu
Su, Kang-Yi
Hsieh, Min-Shu
Chang, Yih-Leong
Huang, Derek De-Rui
Yang, James Chih-Hsin
Venue: The Lancet Respiratory Medicine
Publisher: Elsevier BV
Published: 2018-02
Volume: 6
Issue: 2
Pages: 107-116
ISSN: 2213-2600 (ISSN-L)
DOI: 10.1016/s2213-2600(17)30480-0
OpenAlex: W2772237551
Cited by: 145
References: 23
Citations by year: 2026: 3 · 2025: 8 · 2024: 13 · 2023: 16 · 2022: 15 · 2021: 29 · 2020: 20 · 2019: 24 · 2018: 16 · 2017: 1
FWCI: 13.80
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: The Lancet Respiratory Medicine (publishedVersion)
PubMed (publishedVersion)
Funders: AstraZeneca
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: non-small cell lung cancer, osimertinib, acquired resistance, EGFR tyrosine kinase inhibitors, EGFR activating mutations, plasma biomarkers, resistance mechanisms, progression-free survival, overall survival, post-progression survival, third-generation EGFR-TKI
MeSH terms: Acrylamides, Adult, Aged, Aged, 80 and over, Aniline Compounds, Antineoplastic Agents, Carcinoma, Non-Small-Cell Lung, Female, Humans, Indoles, Lung Neoplasms, Male, Middle Aged, Mutation, Piperazines, Pyrimidines, Retrospective Studies, Genomics, ErbB Receptors

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Outcomes in patients with non-small-cell lung cancer and acquired Thr790Met mutation treated with osimertinib: a genomic study

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