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• W3136294815 abstract "Up to 40% of patients with epithelial growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) develop central nervous system(CNS) metastases throughout their disease. CNS metastasis has a negative impact on survival and quality of life including neurological dysfunction and cognitive impairment. However, the first- and second-generation EGFR-tyrosine kinase inhibitors (TKIs) have limited efficacy because of their limited blood-brain barrier permeability. Osimertinib, third-generation EGFR-TKI with selective activity for both sensitizing and EGFR T790M mutations, have showed higher CNS penetration ability over first- and second-generation EGFR-TKIs. Herein we conducted post hoc analyses of ASTRIS, a clinical study of osimertinib to demonstrate its potential role of intracranial response in a real-world cohort. This was a preplanned, exploratory analysis of CNS activity of osimertinib in Korean subgroup of ASTRIS trial, an open-label, single-arm, real-world treatment study to evaluate the efficacy and safety of osimertinib (80mg orally, once daily) in patients with EGFR T790M mutation-positive NSCLC who progressed upon prior EGFR-TKIs. We classified the patients according to the baseline brain status including leptomeningeal metastases(LM) by blinded independent central review (BICR). A CNS measurable lesion was defined as the lesion which was ≥ 10mm in longest diameter by BICR.We collected the information regarding patients’ baseline characteristics, mutation stutus, intracranial and extracranial responses with duration for ananlysis. The median age was 60 years and 69.7% of patients were female. Seventy-seven patients (86.5%) were Eastern Cooperative Oncology Group performance status (ECOG) less than 2. All patients had common baseline EGFR mutation (Exon 19deletion or L858R) except one patients with G719X mutation. Sixty-five patient (73.0%) had BM at baseline and 19 patients (23.5%) had additional LM. Among patients with BM, 24 (36.9%) had ≥ 1 measurable lesion and 16 had evaluated for the objective response. For the patient with BM and/or LM at baseline, eventually 28 patient had intracranial progression and for the paitent without BM or LM at baseline two had newly developed lesion during treatment. The Intracranial objective response rate (cORR) and disease control rate(cDCR) was 62.5% (95% confidence interval [CI], 38.3–82.6%) and 93.8% (95% CI, 74.3–99.3%), respectively. The median intracranial progression-free survival (cPFS) which included any cause of death as an event, was 13.0 (95% CI, 7.21–18.8) month including patients with measurable and/or non-measurable BM or LM. Our cORR, cDCR, and cPFS were comparable to those observed in previous clinical trials. The outcome of this study is expected to be helpful demonstrating the potential role of intracranial efficacies of osimertinib 80 mg administration in T790M-positive advanced NSCLC with/without BM or LM. Further analysis of overall survival, specific response rate of patient with LM and biomarker for intracranial response or progression are ongoing." @default.
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• W3136294815 date "2021-03-01" @default.
• W3136294815 modified "2023-09-26" @default.
• W3136294815 title "FP14.14 Post Hoc Analyses from an Open Label, Multi-Centre, ASTRIS Trial of Efficacy of Osimertinib for CNS Metastases with T790M-Positive Advanced NSCLC" @default.
• W3136294815 doi "https://doi.org/10.1016/j.jtho.2021.01.157" @default.
• W3136294815 hasPublicationYear "2021" @default.
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