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Osimertinib for Patients With Leptomeningeal Metastases Associated With EGFR T790M-Positive Advanced NSCLC: The AURA Leptomeningeal Metastases Analysis
- Source :
- Journal of Thoracic Oncology. 15:637-648
- Publication Year :
- 2020
- Publisher :
- Elsevier BV, 2020.
-
Abstract
- Introduction Osimertinib has shown promising activity in patients with leptomeningeal metastases (LMs) of EGFR-positive NSCLC at 160 mg once daily (qd) (BLOOM; NCT02228369). We report LM activity with osimertinib (80 mg qd) in a retrospective analysis of studies across the AURA program (AURA extension, AURA2, AURA17, and AURA3). Methods Patients with EGFR T790M-positive advanced NSCLC and progression after previous EGFR-tyrosine kinase inhibitor therapy received osimertinib (80 mg qd). Patients with central nervous system (CNS) metastases (including LMs) were eligible if the lesions were neurologically asymptomatic and stable. Patients with evidence of LMs at the study entry were retrospectively included for the analysis; brain scans were assessed for radiologic LM response by neuroradiologically blinded, independent central review per the modified Response Assessment in Neuro-Oncology LM criteria. LM objective response rate, duration of response, progression-free survival, and overall survival were assessed. A longitudinal analysis was performed to investigate the relationship between changes from the baseline in non-CNS tumor sizes and LM responses at each visit of patients in AURA LM and BLOOM studies. Results For the 22 patients included in the analysis, LM objective response rate was 55% (95% confidence interval [CI]: 32–76). Median LM duration of response was not reached (95% CI: 2.8–not calculable [NC]). Median LM progression-free survival and overall survival were 11.1 months (95% CI: 4.6–NC) and 18.8 months (95% CI: 6.3–NC), respectively. The longitudinal analysis revealed similar non-CNS and LM responses between the patients in AURA LM and BLOOM programs. Conclusions Patients with EGFR T790M-positive NSCLC and radiologically detected LM obtained clinical benefit from osimertinib (80 mg qd).
- Subjects :
- 0301 basic medicine
Pulmonary and Respiratory Medicine
Oncology
medicine.medical_specialty
Lung Neoplasms
Aura
Antineoplastic Agents
EGFR T790M
Asymptomatic
03 medical and health sciences
T790M
0302 clinical medicine
Internal medicine
medicine
Humans
Osimertinib
In patient
Protein Kinase Inhibitors
Objective response
Retrospective Studies
Acrylamides
Aniline Compounds
business.industry
Confidence interval
ErbB Receptors
030104 developmental biology
030220 oncology & carcinogenesis
Mutation
medicine.symptom
business
Subjects
Details
- ISSN :
- 15560864
- Volume :
- 15
- Database :
- OpenAIRE
- Journal :
- Journal of Thoracic Oncology
- Accession number :
- edsair.doi.dedup.....d064a5d53b551650e96cca9830ff041e