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Osimertinib in Patients with T790M-Positive Advanced Non-small Cell Lung Cancer: Korean Subgroup Analysis from Phase II Studies

 Myung-Ju Ahn  ;  Ji-Youn Han  ;  Dong-Wan Kim  ;  Byoung Chul Cho  ;  Jin-Hyoung Kang  ;  Sang-We Kim  ;  James Chih-Hsin Yang  ;  Tetsuya Mitsudomi  ;  Jong Seok Lee 
 CANCER RESEARCH AND TREATMENT, Vol.52(1) : 284-291, 2020-01 
Journal Title
Issue Date
Acrylamides / administration & dosage ; Acrylamides / adverse effects ; Acrylamides / therapeutic use* ; Adult ; Aged ; Alleles ; Amino Acid Substitution ; Aniline Compounds / administration & dosage ; Aniline Compounds / adverse effects ; Aniline Compounds / therapeutic use* ; Antineoplastic Agents / administration & dosage ; Antineoplastic Agents / adverse effects ; Antineoplastic Agents / therapeutic use ; Carcinoma, Non-Small-Cell Lung / diagnosis ; Carcinoma, Non-Small-Cell Lung / drug therapy* ; Carcinoma, Non-Small-Cell Lung / genetics* ; Carcinoma, Non-Small-Cell Lung / mortality ; ErbB Receptors / genetics ; Female ; Humans ; Kaplan-Meier Estimate ; Lung Neoplasms / diagnosis ; Lung Neoplasms / drug therapy* ; Lung Neoplasms / genetics* ; Lung Neoplasms / mortality ; Male ; Middle Aged ; Mutation* ; Prognosis ; Protein Kinase Inhibitors / administration & dosage ; Protein Kinase Inhibitors / adverse effects ; Protein Kinase Inhibitors / therapeutic use ; Republic of Korea ; Treatment Outcome
Non-small-cell lung carcinoma ; Tyrosine kinase inhibitor ; Epidermal growth factor receptor ; South Korea ; Clinical trial ; Phase II
Purpose Osimertinib is a third-generation, irreversible, oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR sensitizing mutation and EGFR T790M and has demonstrated efficacy in non-small cell lung cancer (NSCLC) central nervous system (CNS) metastases. We present results of a subgroup analysis of Korean patients from the pooled data of two global phase II trials: AURA extension (NCT01802632) and AURA2 (NCT02094261). Materials and Methods Enrolled patients had EGFR T790M-positive NSCLC and disease progression during or after EGFR-TKI therapy. Patients received osimertinib 80 mg orally once daily until disease progression. The primary endpoint was objective response rate (ORR). Results In total, 66 Korean patients received osimertinib treatment with a median treatment duration of 19 months. In the evaluable-for-response population (n=62), ORR was 74% (95% confidence interval [CI], 61.5 to 84.5) and median duration of response was 9.8 months (95% CI, 7.1 to 16.8). In the full analysis set (n=66), median progression-free survival was 10.9 months (95% CI, 8.3 to 15.0; data cutoff November 1, 2016), and median overall survival was 29.2 months (95% CI, 24.8 to 35.7; data cutoff May 1, 2018). Eight patients with CNS metastases were evaluable for response, none of whom showed CNS progression. The most common adverse events were rash (53%), cough (33%), paronychia, diarrhea, and decreased appetite (each 32%). Conclusion Efficacy and safety profiles of osimertinib in this subgroup are consistent with the global phase II pooled population, which supports osimertinib as a recommended treatment for Korean patients with T790M positive NSCLC.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
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