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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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356339/ https://www.ncbi.nlm.nih.gov/pubmed/32517152 http://dx.doi.org/10.3390/jcm9061762 |
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author | Nakao, Akira Hiranuma, Osamu Uchino, Junji Sakaguchi, Chikara Araya, Tomoyuki Hiraoka, Noriya Ishizuka, Tamotsu Takeda, Takayuki Kawasaki, Masayuki Goto, Yasuhiro Imai, Hisao Hattori, Noboru Nakatomi, Keita Uramoto, Hidetaka Uryu, Kiyoaki Fukuda, Minoru Uchida, Yasuki Yokoyama, Toshihide Akai, Masaya Mio, Tadashi Nagashima, Seiji Chihara, Yusuke Tamiya, Nobuyo Kaneko, Yoshiko Mouri, Takako Yamada, Tadaaki Yoshimura, Kenichi Fujita, Masaki Takayama, Koichi |
author_facet | Nakao, Akira Hiranuma, Osamu Uchino, Junji Sakaguchi, Chikara Araya, Tomoyuki Hiraoka, Noriya Ishizuka, Tamotsu Takeda, Takayuki Kawasaki, Masayuki Goto, Yasuhiro Imai, Hisao Hattori, Noboru Nakatomi, Keita Uramoto, Hidetaka Uryu, Kiyoaki Fukuda, Minoru Uchida, Yasuki Yokoyama, Toshihide Akai, Masaya Mio, Tadashi Nagashima, Seiji Chihara, Yusuke Tamiya, Nobuyo Kaneko, Yoshiko Mouri, Takako Yamada, Tadaaki Yoshimura, Kenichi Fujita, Masaki Takayama, Koichi |
author_sort | Nakao, Akira |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-7356339 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-73563392020-07-30 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 Nakao, Akira Hiranuma, Osamu Uchino, Junji Sakaguchi, Chikara Araya, Tomoyuki Hiraoka, Noriya Ishizuka, Tamotsu Takeda, Takayuki Kawasaki, Masayuki Goto, Yasuhiro Imai, Hisao Hattori, Noboru Nakatomi, Keita Uramoto, Hidetaka Uryu, Kiyoaki Fukuda, Minoru Uchida, Yasuki Yokoyama, Toshihide Akai, Masaya Mio, Tadashi Nagashima, Seiji Chihara, Yusuke Tamiya, Nobuyo Kaneko, Yoshiko Mouri, Takako Yamada, Tadaaki Yoshimura, Kenichi Fujita, Masaki Takayama, Koichi J Clin Med Article 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. MDPI 2020-06-05 /pmc/articles/PMC7356339/ /pubmed/32517152 http://dx.doi.org/10.3390/jcm9061762 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Nakao, Akira Hiranuma, Osamu Uchino, Junji Sakaguchi, Chikara Araya, Tomoyuki Hiraoka, Noriya Ishizuka, Tamotsu Takeda, Takayuki Kawasaki, Masayuki Goto, Yasuhiro Imai, Hisao Hattori, Noboru Nakatomi, Keita Uramoto, Hidetaka Uryu, Kiyoaki Fukuda, Minoru Uchida, Yasuki Yokoyama, Toshihide Akai, Masaya Mio, Tadashi Nagashima, Seiji Chihara, Yusuke Tamiya, Nobuyo Kaneko, Yoshiko Mouri, Takako Yamada, Tadaaki Yoshimura, Kenichi Fujita, Masaki Takayama, Koichi 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 | 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 | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7356339/ https://www.ncbi.nlm.nih.gov/pubmed/32517152 http://dx.doi.org/10.3390/jcm9061762 |
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