Osimertinib in patients with T790M-positive advanced non-small cell lung cancer: Korean subgroup analysis from phase II studies
Journal
Cancer Research and Treatment
Journal Volume
52
Journal Issue
1
Pages
284-291
Date Issued
2020
Author(s)
Abstract
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. ? 2020 by the Korean Cancer Association
Subjects
Clinical trial; Epidermal growth factor receptor; Non-small-cell lung carcinoma; Phase II; South Korea; Tyrosine kinase inhibitor
SDGs
Other Subjects
alanine aminotransferase; osimertinib; acrylamide derivative; aniline derivative; antineoplastic agent; EGFR protein, human; epidermal growth factor receptor; osimertinib; protein kinase inhibitor; acne; adult; advanced cancer; aged; alanine aminotransferase blood level; anemia; Article; backache; cancer patient; central nervous system metastasis; constipation; coughing; decreased appetite; dermatitis; diarrhea; disease exacerbation; drug efficacy; drug safety; drug withdrawal; dry skin; dyspepsia; fatigue; female; human; insomnia; interstitial lung disease; Korea; Korean (people); leukocyte count; major clinical study; male; multicenter study; musculoskeletal chest pain; musculoskeletal pain; nausea; neutrophil count; non small cell lung cancer; open study; overall survival; paronychia; phase 2 clinical trial; platelet count; pneumonia; progression free survival; pruritus; rash; side effect; stomatitis; treatment duration; treatment response; upper respiratory tract infection; vomiting; allele; amino acid substitution; clinical trial; genetics; Kaplan Meier method; lung tumor; middle aged; mortality; mutation; non small cell lung cancer; prognosis; South Korea; treatment outcome; Acrylamides; Adult; Aged; Alleles; Amino Acid Substitution; Aniline Compounds; Antineoplastic Agents; Carcinoma, Non-Small-Cell Lung; ErbB Receptors; Female; Humans; Kaplan-Meier Estimate; Lung Neoplasms; Male; Middle Aged; Mutation; Prognosis; Protein Kinase Inhibitors; Republic of Korea; Treatment Outcome
Publisher
Korean Cancer Association
Type
journal article