Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous Treatment
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are used for treating EGFR-mutated lung cancer, and osimertinib is effective in cases that acquired T790M mutations after treatment with the first- and second-generation EGFR-TKIs. However, no study has evaluated its safety and...
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MDPI AG
2020-06-01
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| author | Akira Nakao Osamu Hiranuma Junji Uchino Chikara Sakaguchi Tomoyuki Araya Noriya Hiraoka Tamotsu Ishizuka Takayuki Takeda Masayuki Kawasaki Yasuhiro Goto Hisao Imai Noboru Hattori Keita Nakatomi Hidetaka Uramoto Kiyoaki Uryu Minoru Fukuda Yasuki Uchida Toshihide Yokoyama Masaya Akai Tadashi Mio Seiji Nagashima Yusuke Chihara Nobuyo Tamiya Yoshiko Kaneko Takako Mouri Tadaaki Yamada Kenichi Yoshimura Masaki Fujita Koichi Takayama |
| author_facet | Akira Nakao Osamu Hiranuma Junji Uchino Chikara Sakaguchi Tomoyuki Araya Noriya Hiraoka Tamotsu Ishizuka Takayuki Takeda Masayuki Kawasaki Yasuhiro Goto Hisao Imai Noboru Hattori Keita Nakatomi Hidetaka Uramoto Kiyoaki Uryu Minoru Fukuda Yasuki Uchida Toshihide Yokoyama Masaya Akai Tadashi Mio Seiji Nagashima Yusuke Chihara Nobuyo Tamiya Yoshiko Kaneko Takako Mouri Tadaaki Yamada Kenichi Yoshimura Masaki Fujita Koichi Takayama |
| author_sort | Akira Nakao |
| collection | DOAJ |
| description | Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are used for treating EGFR-mutated lung cancer, and osimertinib is effective in cases that acquired T790M mutations after treatment with the first- and second-generation EGFR-TKIs. However, no study has evaluated its safety and efficacy in older patients. This phase II trial (jRCTs071180002) evaluated osimertinib in T790M mutation-positive Japanese patients who were ≥75 years old and had experienced relapse or progression after previous EGFR-TKI treatment. Our previous report that enrolled 36 patients showed the overall response rate (58.3%) and disease control rate (97.2%), while this report describes the results for the progression-free survival (PFS), overall survival (OS), and safety analyses. The median PFS was 11.9 months (95% confidence interval (CI): 7.9–17.5), and the median OS was 22.0 months (95% CI: 16.0 months–not reached). The most frequent adverse events were anemia/hypoalbuminemia (27 patients, 75.0%), thrombocytopenia (21 patients, 58.3%), and paronychia/anorexia/diarrhea/neutropenia (15 patients, 41.7%). Pneumonitis was observed in four patients (11.1%), including two patients (5.6%) with Grade 3–4 pneumonitis. These results suggest that osimertinib was relatively safe and effective for non-small cell lung cancer that acquired T790M mutations after previous EGFR-TKI treatment, even among patients who were ≥75 years old. |
| first_indexed | 2024-03-10T19:20:23Z |
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| issn | 2077-0383 |
| language | English |
| last_indexed | 2024-03-10T19:20:23Z |
| publishDate | 2020-06-01 |
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| spelling | doaj.art-eaa7ace1f3b94595974301fefd2296412023-11-20T03:02:06ZengMDPI AGJournal of Clinical Medicine2077-03832020-06-0196176210.3390/jcm9061762Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous TreatmentAkira Nakao0Osamu Hiranuma1Junji Uchino2Chikara Sakaguchi3Tomoyuki Araya4Noriya Hiraoka5Tamotsu Ishizuka6Takayuki Takeda7Masayuki Kawasaki8Yasuhiro Goto9Hisao Imai10Noboru Hattori11Keita Nakatomi12Hidetaka Uramoto13Kiyoaki Uryu14Minoru Fukuda15Yasuki Uchida16Toshihide Yokoyama17Masaya Akai18Tadashi Mio19Seiji Nagashima20Yusuke Chihara21Nobuyo Tamiya22Yoshiko Kaneko23Takako Mouri24Tadaaki Yamada25Kenichi Yoshimura26Masaki Fujita27Koichi Takayama28Department of Respiratory Medicine, Faculty of Medicine, Fukuoka University, Fukuoka 814-0180, JapanDepartment of Respiratory Medicine, Otsu City Hospital, Shiga 520-0804, JapanDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto 602-8566, JapanDepartment of Pulmonary Medicine, Rakuwakai Otowa Hospital, Kyoto 607-8062, JapanDepartment of Respiratory Medicine, National Hospital Organization, Kanazawa Medical Center, Ishikawa 920-8650, JapanDepartment of Respiratory Medicine, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto 605-0981, JapanThird Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui, Fukui 910-1193, JapanDepartment of Respiratory Medicine, Japanese Red Cross Society Kyoto Daini Hospital, Kyoto 602-8026, JapanDepartment of Respiratory Medicine, National Hospital Organization, Omuta National Hospital, Fukuoka 837-0911, JapanDepartment of Respiratory Medicine, Fujita Health University, Aichi 470-1192, JapanDivision of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma 373-8550, JapanDepartment of Molecular and Internal Medicine, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima 734-8553, JapanDepartment of Respiratory Medicine, Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka 815-8588, JapanDepartment of Thoracic Surgery, Kanazawa Medical University, Ishikawa 920-0293, JapanDepartment of Respiratory Medicine, Yao Tokushukai General Hospital, Osaka 581-0011, JapanSecond Department of Internal Medicine, Nagasaki University Hospital, Nagasaki 852-8523, JapanDepartment of Respiratory Medicine, Shiga University of Medical Science Hospital, Shiga 520-2192, JapanDepartment of Respiratory Medicine, Kurashiki Central Hospital, Okayama 710-8602, JapanDepartment of Respiratory Medicine, Japanese Red Cross Fukui Hospital, Fukui 918-8501, JapanDivision of Respiratory Medicine, Center for Respiratory Diseases, National Hospital Organization Kyoto Medical Center, Kyoto 612-8555, JapanDepartment of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center, Nagasaki 856-0835, JapanDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto 602-8566, JapanDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto 602-8566, JapanDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto 602-8566, JapanDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto 602-8566, JapanDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto 602-8566, JapanCenter for Integrated Medical Research, Hiroshima University Hospital, Hiroshima University, Hiroshima 734-8553, JapanDepartment of Respiratory Medicine, Faculty of Medicine, Fukuoka University, Fukuoka 814-0180, JapanDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto 602-8566, JapanEpidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are used for treating EGFR-mutated lung cancer, and osimertinib is effective in cases that acquired T790M mutations after treatment with the first- and second-generation EGFR-TKIs. However, no study has evaluated its safety and efficacy in older patients. This phase II trial (jRCTs071180002) evaluated osimertinib in T790M mutation-positive Japanese patients who were ≥75 years old and had experienced relapse or progression after previous EGFR-TKI treatment. Our previous report that enrolled 36 patients showed the overall response rate (58.3%) and disease control rate (97.2%), while this report describes the results for the progression-free survival (PFS), overall survival (OS), and safety analyses. The median PFS was 11.9 months (95% confidence interval (CI): 7.9–17.5), and the median OS was 22.0 months (95% CI: 16.0 months–not reached). The most frequent adverse events were anemia/hypoalbuminemia (27 patients, 75.0%), thrombocytopenia (21 patients, 58.3%), and paronychia/anorexia/diarrhea/neutropenia (15 patients, 41.7%). Pneumonitis was observed in four patients (11.1%), including two patients (5.6%) with Grade 3–4 pneumonitis. These results suggest that osimertinib was relatively safe and effective for non-small cell lung cancer that acquired T790M mutations after previous EGFR-TKI treatment, even among patients who were ≥75 years old.https://www.mdpi.com/2077-0383/9/6/1762non-small cell lung cancerEGFR-TKIT790Mosimertinib |
| spellingShingle | Akira Nakao Osamu Hiranuma Junji Uchino Chikara Sakaguchi Tomoyuki Araya Noriya Hiraoka Tamotsu Ishizuka Takayuki Takeda Masayuki Kawasaki Yasuhiro Goto Hisao Imai Noboru Hattori Keita Nakatomi Hidetaka Uramoto Kiyoaki Uryu Minoru Fukuda Yasuki Uchida Toshihide Yokoyama Masaya Akai Tadashi Mio Seiji Nagashima Yusuke Chihara Nobuyo Tamiya Yoshiko Kaneko Takako Mouri Tadaaki Yamada Kenichi Yoshimura Masaki Fujita Koichi Takayama Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous Treatment Journal of Clinical Medicine non-small cell lung cancer EGFR-TKI T790M osimertinib |
| title | Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous Treatment |
| title_full | Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous Treatment |
| title_fullStr | Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous Treatment |
| title_full_unstemmed | Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous Treatment |
| title_short | Final Results from a Phase II Trial of Osimertinib for Elderly Patients with Epidermal Growth Factor Receptor t790m-Positive Non-Small Cell Lung Cancer That Progressed during Previous Treatment |
| title_sort | final results from a phase ii trial of osimertinib for elderly patients with epidermal growth factor receptor t790m positive non small cell lung cancer that progressed during previous treatment |
| topic | non-small cell lung cancer EGFR-TKI T790M osimertinib |
| url | https://www.mdpi.com/2077-0383/9/6/1762 |
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