Objectives: The aim of ASTRIS, a real-world study, was to assess the safety and efficacy of osimertinib in patients with locally advanced or metastatic (stage IIIB-IV) epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) who had received prior EGFR-tyrosine kinase inhibitor (TKI) therapy. Here, we describe the Belgian subset of the global ASTRIS study.Methods: Patients received osimertinib orally as one 80 mg tablet once daily until disease progression or unacceptable toxicity. Socio-demographic data, medical history, disease progression and survival status were collected and molecular testing for EGFR status was performed. Safety was also assessed. All collected data were summarized using descriptive statistics.Results: Of the 31 Belgian patients enrolled in the study, 9 (29.0%) discontinued treatment for disease progression and 5 (16.1%) due to other reasons. Among the 31 patients treated with osimertinib, 16 (51.6%, 95% CI 33.1-69.8) had a clinical response and 13 (41.9%) had stable disease as best response assessed by the investigator, with a disease control rate of 93.5%. The clinical response rate was 66.7% (6/9) in patients with brain/leptomeningeal metastases and 50.0% (4/8) in patients without brain/leptomeningeal metastases. About one third of the patients (11/31) reported at least one adverse event (AE) (35.5%) or serious AE (10/31; 32.3%) and 3/31 (9.7%) patients discontinued treatment due to AEs.Conclusion: We here demonstrate the effectiveness of osimertinib in a real-world setting in Belgian patients with locally advanced or metastatic T790M-positive NSCLC who had received previous EGFR-TKI treatment. No new safety signals were identified.
Keywords: Non-small cell lung cancer; T790M epidermal growth factor receptor mutation; osimertinib; real-world data; tyrosine kinase inhibitor.