Trial reportJapanese journal of clinical oncology2020
Real-world use of osimertinib for epidermal growth factor receptor T790M-positive non-small cell lung cancer in Japan.
Trial report in Japanese journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed.
- Osimertinib-induced interstitial lung disease insights from faers signal detection and network toxicology analysis.BMC cancer · 2026Article
- Almonertinib-induced interstitial lung disease in an NSCLC patient co-harboring EGFR Ex19del mutation and METFrontiers in oncology · 2025Article
- Efficacy of osimertinib in patients with EGFR-mutation positive non-small cell lung cancer with malignant pleural effusion.Thoracic cancer · 2024Article
- Variation in Use of Lung Cancer Targeted Therapies Across State Medicaid Programs, 2020-2021.JAMA network open · 2023Article
- Real-World Study of Osimertinib in Korean Patients with Epidermal Growth Factor Receptor T790M Mutation-Positive Non-Small Cell Lung Cancer.Cancer research and treatment · 2023Article
- The real-life efficacy and safety of osimertinib in pretreated advanced non-small cell lung cancer patients with T790M mutation: a Turkish Oncology Group Study.Journal of cancer research and clinical oncology · 2022Article
- Efficacy of osimertinib in epidermal growth factor receptor-mutated non-small-cell lung cancer patients with pleural effusion.BMC cancer · 2022Article
- Case Report: Torsade de Pointes Induced by the Third-Generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor Osimertinib Combined With Litsea Cubeba.Frontiers in cardiovascular medicine · 2022Article
- Molecular and Clinical Features of EGFR-TKI-Associated Lung Injury.International journal of molecular sciences · 2021Review
- Machine Learning-Based CT Radiomics Analysis for Prognostic Prediction in Metastatic Non-Small Cell Lung Cancer Patients WithFrontiers in oncology · 2021Article
- Temporal Trends in Antineoplastic Agent-associated Interstitial Lung Disease Involving Immune Checkpoint Inhibitors in the JADER Database.In vivo (Athens, Greece)Article
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveAdverse drug reactions (ADRs) during real-world osimertinib use were investigated in Japan.
methodsPatients with epidermal growth factor receptor (EGFR) T790M-positive non-small cell lung cancer treated with second-line or later oral osimertinib per the Japanese package insert (80 mg once daily) were included. Data were collected between 28 March 2016 and 31 August 2018.
resultsThe median observation period in the safety analysis population (n = 3578) was 343.0 days. ADRs (defined as adverse events whose causality to osimertinib could not be denied by the attending physicians or manufacturer) were reported in 58.1% (2079/3578) of patients. ADRs of interstitial lung disease events were reported in 6.8% (245/3578; Grade ≥ 3, 2.9% [104/3578]) of patients, of whom 29 (11.8%) died (0.8% of patients overall). ADRs of QT interval prolonged, liver disorder and haematotoxicity were reported in 1.3% (45/3578; Grade ≥ 3, 0.1% [5/3578]), 5.9% (212/3578; Grade ≥ 3, 1.0% [35/3578]) and 11.4% (409/3578; Grade ≥ 3, 2.9% [104/3578]) of patients, respectively. In the efficacy analysis population (n = 3563), 119 (3.3%) patients had complete responses, 2373 (66.6%) had partial responses and 598 (16.8%) had stable disease. The objective response rate was 69.9%; disease control rate was 86.7%; and median progression-free survival (PFS) was 12.3 months. At 6 and 12 months, PFS rates were 77.4% (95% confidence interval [CI], 75.9-78.9) and 53.2% (95% CI, 51.3-55.1) and overall survival rates were 88.3% (95% CI, 87.2-89.4) and 75.4% (95% CI, 73.8-77.0), respectively.
conclusionsThese data support the currently established benefit-risk assessment of osimertinib in this patient population.
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