Real-world use of osimertinib for epidermal growth factor receptor T790M-positive non-small cell lung cancer in Japan
| العنوان: | Real-world use of osimertinib for epidermal growth factor receptor T790M-positive non-small cell lung cancer in Japan |
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| المؤلفون: | Yoshinobu Saito, Masahiko Kusumoto, Yuichiro Ohe, Masafumi Sata, Kei Sakamoto, Terufumi Kato, Toshimitsu Tokimoto, Reiko Tamura, Tomohisa Baba, Akihiko Gemma, Masatoshi Sugeno, Ou Yamaguchi, Wataru Shimizu, Masahiro Endo, Fumikazu Sakai |
| المصدر: | Japanese Journal of Clinical Oncology |
| بيانات النشر: | Oxford University Press, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | 0301 basic medicine, safety, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Population, QT interval, Gastroenterology, Liver disorder, 03 medical and health sciences, 0302 clinical medicine, Japan, Internal medicine, Carcinoma, Non-Small-Cell Lung, Medicine, AcademicSubjects/MED00300, Humans, Radiology, Nuclear Medicine and imaging, Osimertinib, Lung cancer, education, Adverse effect, Protein Kinase Inhibitors, non-small cell lung cancer, Aged, education.field_of_study, Acrylamides, Aniline Compounds, business.industry, Interstitial lung disease, General Medicine, medicine.disease, Confidence interval, Progression-Free Survival, ErbB Receptors, Survival Rate, 030104 developmental biology, Treatment Outcome, Oncology, 030220 oncology & carcinogenesis, osimertinib, Mutation, Original Article, Female, business, epidermal growth factor receptor |
| الوصف: | Objective Adverse drug reactions (ADRs) during real-world osimertinib use were investigated in Japan. Methods Patients 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. Results The 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. Conclusions These data support the currently established benefit-risk assessment of osimertinib in this patient population. Real-world safety and efficacy data from Japanese patients with EGFR T790M-positive NSCLC support the currently established benefit-risk assessment of osimertinib in this patient population. |
| اللغة: | English |
| تدمد: | 1465-3621 0368-2811 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d3b4556abdbca0ecb767d113e698aa22Test http://europepmc.org/articles/PMC7401719Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....d3b4556abdbca0ecb767d113e698aa22 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14653621 03682811 |
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