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Osimertinib for Japanese patients with T790M-positive advanced non-small-cell lung cancer: A pooled subgroup analysis.
- Source :
-
Cancer science [Cancer Sci] 2019 Sep; Vol. 110 (9), pp. 2884-2893. Date of Electronic Publication: 2019 Aug 01. - Publication Year :
- 2019
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Abstract
- Epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) are the standard of care for non-small-cell lung cancer (NSCLC) patients harboring EGFR mutations. However, almost all patients develop resistance after approximately 1 y of treatment, with >50% of cases due to the T790M secondary mutation of the EGFR gene. A large global Phase III study (AURA3) demonstrated that osimertinib significantly prolonged progression-free survival (PFS) over platinum-doublet chemotherapy in patients with T790M-positive NSCLC who had progressed on previous EGFR-TKI therapy. However, it is not clear whether efficacy or safety of osimertinib in Japanese patients is similar to the overall population. We report a pre-planned subgroup analysis of pooled Phase II data from the AURA Extension and AURA2 trials to investigate the efficacy and safety of osimertinib in Japanese patients. This study included 81 Japanese patients. Patients were administered 80 mg osimertinib orally once daily until disease progression. The main endpoints were objective response rate (ORR), PFS, and safety. The ORR was 63.6% and median PFS was 13.8 mo. Overall survival rate at 36 mo was 54.0%. The most common all-cause adverse events (AEs) were rash (grouped term; 65.4%), diarrhea (51.9%), paronychia (grouped term; 49.4%), and dry skin (grouped term; 39.5%). Most AEs were grade 1-2. Five patients (6.2%) developed interstitial lung disease, resulting in two deaths (2.5%). Osimertinib demonstrated favorable ORR and PFS in Japanese patients, similar to the overall population. Additionally, osimertinib has good efficacy and a manageable safety profile in Japanese patients with NSCLC who had acquired resistance due to the T790M mutation.<br /> (© 2019 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.)
- Subjects :
- Acrylamides adverse effects
Administration, Oral
Adult
Aged
Aged, 80 and over
Aniline Compounds adverse effects
Antineoplastic Agents adverse effects
Carcinoma, Non-Small-Cell Lung genetics
Carcinoma, Non-Small-Cell Lung mortality
Carcinoma, Non-Small-Cell Lung pathology
Diarrhea chemically induced
Diarrhea epidemiology
Disease Progression
Drug Resistance, Neoplasm drug effects
Drug Resistance, Neoplasm genetics
ErbB Receptors antagonists & inhibitors
ErbB Receptors genetics
Exanthema chemically induced
Exanthema epidemiology
Humans
Japan epidemiology
Lung Diseases, Interstitial chemically induced
Lung Diseases, Interstitial epidemiology
Lung Neoplasms genetics
Lung Neoplasms mortality
Lung Neoplasms pathology
Middle Aged
Paronychia chemically induced
Paronychia epidemiology
Progression-Free Survival
Protein Kinase Inhibitors adverse effects
Survival Analysis
Survival Rate
Acrylamides administration & dosage
Aniline Compounds administration & dosage
Antineoplastic Agents administration & dosage
Carcinoma, Non-Small-Cell Lung drug therapy
Lung Neoplasms drug therapy
Protein Kinase Inhibitors administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1349-7006
- Volume :
- 110
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Cancer science
- Publication Type :
- Academic Journal
- Accession number :
- 31265163
- Full Text :
- https://doi.org/10.1111/cas.14120