Real-World Evaluation of Factors for Interstitial Lung Disease Incidence and Radiologic Characteristics in Patients With EGFR T790M–positive NSCLC Treated With Osimertinib in Japan

Abstract

Introduction: Using real-world Japanese postmarketing data, we characterized interstitial lung disease (ILD) development during the second-or later-line osimertinib treatment for EGFR mutation-positive NSCLC. Retrospective radiologic image evaluation of patients developing ILD was also performed.Methods: Patients who had ILD events reported as an adverse drug reaction by their physicians and who were assessed as having developed ILD as assessed by an ILD expert committee in Japan were included.Results: Among 3578 patients, 252 ILD events were reported in 245 patients (6.8%) by their attending physicians. The median (range) time to the first onset of ILD after

Radiographic features and poor prognostic factors of interstitial lung disease with nivolumab for non–small cell lung cancer

“…ILD has been reported in patients with NSCLC who received osimertinib after nivolumab treatment, 23,24 and a PMS study of osimertinib treatment in Japan identified prior nivolumab treatment as a potential factor associated with ILD onset during osimertinib treatment in patients with EGFR T790M-positive NSCLC. 25 The main strength of this study was the evaluation of nivolumab-associated ILD in a real-world setting, as opposed to a clinical trial setting where patients with poor performance status or underlying ILD are likely to be excluded. Other strengths included sufficiently large sample size (>200 patients) to allow identification of risk factors contributing to a poor prognosis, and central evaluation of ILD radiographic images by a committee with a high degree of expertise.…”

“…In total, 29 patients were excluded because they had also received an EGFR TKI, including 22 patients who had received the third‐generation EGFR TKI osimertinib after the end of nivolumab treatment. ILD has been reported in patients with NSCLC who received osimertinib after nivolumab treatment, 23,24 and a PMS study of osimertinib treatment in Japan identified prior nivolumab treatment as a potential factor associated with ILD onset during osimertinib treatment in patients with EGFR T790M–positive NSCLC 25 …”

First-line Osimertinib for Poor Performance Status Patients With EGFR Mutation-positive Non-small Cell Lung Cancer: A Prospective Observational Study

“…Additionally, ILD due to osimertinib was observed in two patients (12%), indicating that ILD incidence may be high in poor PS patients treated with osimertinib.Meanwhile, the patients with drug-induced ILD recovered after corticosteroid therapy, and no mortality due to druginduced ILD was observed in our study. A previous study demonstrated that 80% of patients with ILD complicated by osimertinib recovered, and that the mortality from drug-induced ILD was lower in those administered osimertinib (11.8%) than in those treated with ge tinib (38.9%) and erlotinib (35.6%) [24], suggesting that recovery from ILD is mostly expected in patients receiving osimertinib.…”

Successful treatment with afatinib following the failure of osimertinib rechallenge with osimertinib-induced interstitial lung disease: A case report

“…As for ILD pattern, chest CT in the present case showed bilateral diffuse GGO. To date, there was a report on ILD pattern of CT which comprised of organizing pneumonia pattern, faint infiltration pattern and diffuse alveolar damage pattern [ 21 ]. The CT pattern in the present case was considered to be uniform faint infiltration pattern, which is a common finding.…”

“…The CT pattern in the present case was considered to be uniform faint infiltration pattern, which is a common finding. However, the relationship with ILD pattern and ILD recurrence is still unclear [ 21 ].…”