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ASTRIS, a large real-world study to evaluate the efficacy of osimertinib in epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer patients: Clinical characteristics and genotyping methods in a Spanish cohort
- Source :
- Revista Española de Patología. 53:140-148
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- Purpose Osimertinib has proven efficacy in EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) patients; however, its benefits have not been evaluated in a real-world setting. Methods ASTRIS is a single-arm, open-label, multinational study to evaluate the efficacy and safety of osimertinib for the treatment of EGFR T790M mutation-positive NSCLC. We present the study design and preliminary cut-off analysis results (as of October 2017) describing the baseline characteristics and methodology for T790M mutation detection in the Spanish cohort. Results The Spanish cohort included 131 patients from a total 3014 patients. Forty patients (28.1%) were still undergoing therapy at the time of cut-off; 68.7% were women and 97.7% were Caucasian, with a mean age of 64.8 (SD 11.7) years. The most common type of sample for evaluating T790M mutations was tissue (55.0%), and samples were obtained from the primary tumor in 61.1% of cases. Mutation analysis was performed by the local laboratory in 60.3% of cases and using the Roche Cobas® EGFR assay in 43.5% of cases. Conclusions ASTRIS is expected to confirm the benefits of osimertinib in a real-world setting. Data on real-world practices for the detection of the EGFR T790M mutation may provide additional information for the designing of guidelines for best practices.
- Subjects :
- Male
0301 basic medicine
Oncology
medicine.medical_specialty
Internationality
Lung Neoplasms
Genotyping Techniques
medicine.drug_class
DNA Mutational Analysis
Administration, Oral
Antineoplastic Agents
Tyrosine-kinase inhibitor
Pathology and Forensic Medicine
Cohort Studies
03 medical and health sciences
T790M
0302 clinical medicine
Carcinoma, Non-Small-Cell Lung
Internal medicine
medicine
Humans
Osimertinib
Lung cancer
Genotyping
Aged
Acrylamides
Aniline Compounds
business.industry
Middle Aged
medicine.disease
Primary tumor
respiratory tract diseases
ErbB Receptors
030104 developmental biology
Spain
030220 oncology & carcinogenesis
Mutation (genetic algorithm)
Cohort
Female
business
Subjects
Details
- ISSN :
- 16998855
- Volume :
- 53
- Database :
- OpenAIRE
- Journal :
- Revista Española de Patología
- Accession number :
- edsair.doi.dedup.....d03c578d2fb3fde2dd85b9833d284193