A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer

Satoshi Igawa,1 Masashi Kasajima,1 Taihei Ono,1 Takahiro Ozawa,1 Mikiko Kakegawa,1 Seiichiro Kusuhara,1 Takashi Sato,1 Yoshiro Nakahara,1 Tomoya Fukui,1 Masanori Yokoba,2 Masaru Kubota,2 Hisashi Mitsufuji,3 Jiichiro Sasaki,4 Katsuhiko Naoki1 1Department of Respiratory Medicine, Kitasato University S...

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Autores principales:	Igawa S, Kasajima M, Ono T, Ozawa T, Kakegawa M, Kusuhara S, Sato T, Nakahara Y, Fukui T, Yokoba M, Kubota M, Mitsufuji H, Sasaki J, Naoki K
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	non-small cell lung carcinoma chemotherapy-naïve patients efficacy Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/c4af3cf763734c538771c06213db5f99
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spelling	oai:doaj.org-article:c4af3cf763734c538771c06213db5f992021-11-21T19:08:51ZA Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer1179-1322https://doaj.org/article/c4af3cf763734c538771c06213db5f992021-11-01T00:00:00Zhttps://www.dovepress.com/a-prospective-observational-study-of-osimertinib-for-chemo-naive-elder-peer-reviewed-fulltext-article-CMARhttps://doaj.org/toc/1179-1322Satoshi Igawa,1 Masashi Kasajima,1 Taihei Ono,1 Takahiro Ozawa,1 Mikiko Kakegawa,1 Seiichiro Kusuhara,1 Takashi Sato,1 Yoshiro Nakahara,1 Tomoya Fukui,1 Masanori Yokoba,2 Masaru Kubota,2 Hisashi Mitsufuji,3 Jiichiro Sasaki,4 Katsuhiko Naoki1 1Department of Respiratory Medicine, Kitasato University School of Medicine, Sagamihara-city, Kanagawa, Japan; 2School of Allied Health Sciences, Kitasato University, Sagamihara-city, Kanagawa, Japan; 3Kitasato University School of Nursing, Sagamihara-city, Kanagawa, Japan; 4Kitasato University School of Medicine, Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Sagamihara-city, Kanagawa, JapanCorrespondence: Satoshi IgawaDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara-city, Kanagawa, 252-0374, JapanTel +81-42-778-8506Fax +81-42-778-6412Email igawa@kitasato-u.ac.jpBackground: The clinical outcomes of elderly patients with EGFR-mutated non-small cell lung cancer (NSCLC) who are treated with osimertinib have not been sufficiently evaluated. This study aimed to assess the efficacy and safety of osimertinib in elderly chemotherapy-naive patients with NSCLC harboring sensitive EGFR mutations.Patients and Methods: We assessed the clinical effects of osimertinib as a first-line treatment for elderly NSCLC patients (≥ 75 years of age) with an exon 19 deletion or exon 21 L858R mutation in EGFR. All patients were administered 80 mg/day osimertinib as initial treatment.Results: Forty-three patients (24 women and 19 men) with adenocarcinoma who were treated between August 2018 and July 2021 were included in this study; their median age was 79 years (range, 75– 90 years). The overall objective response rate was 60.5%. The median progression-free survival (PFS) and time to treatment failure (TTF) of the entire patient population were 22.1 months and 14.6 months, respectively. The most common adverse event was rash acneiform (42%), followed by diarrhea (33%) and paronychia (28%); none of these were grades ≥ 3. Interstitial lung disease developed in 8 patients (18.6%); however, no treatment-related deaths occurred. Multivariate analysis identified performance status and disease stage as predictors of PFS and TTF.Conclusion: Considering the findings of this study and despite an observed discordance between PFS and TTF, osimertinib appears to be an effective and safe treatment option in elderly patients with advanced NSCLC harboring sensitive EGFR mutations. To obtain conclusive results, further studies in a larger elderly population are warranted.Keywords: non-small cell lung carcinoma, chemotherapy-naïve patients, efficacyIgawa SKasajima MOno TOzawa TKakegawa MKusuhara SSato TNakahara YFukui TYokoba MKubota MMitsufuji HSasaki JNaoki KDove Medical Pressarticlenon-small cell lung carcinomachemotherapy-naïve patientsefficacyNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENCancer Management and Research, Vol Volume 13, Pp 8695-8705 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	non-small cell lung carcinoma chemotherapy-naïve patients efficacy Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	non-small cell lung carcinoma chemotherapy-naïve patients efficacy Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Igawa S Kasajima M Ono T Ozawa T Kakegawa M Kusuhara S Sato T Nakahara Y Fukui T Yokoba M Kubota M Mitsufuji H Sasaki J Naoki K A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer
description	Satoshi Igawa,1 Masashi Kasajima,1 Taihei Ono,1 Takahiro Ozawa,1 Mikiko Kakegawa,1 Seiichiro Kusuhara,1 Takashi Sato,1 Yoshiro Nakahara,1 Tomoya Fukui,1 Masanori Yokoba,2 Masaru Kubota,2 Hisashi Mitsufuji,3 Jiichiro Sasaki,4 Katsuhiko Naoki1 1Department of Respiratory Medicine, Kitasato University School of Medicine, Sagamihara-city, Kanagawa, Japan; 2School of Allied Health Sciences, Kitasato University, Sagamihara-city, Kanagawa, Japan; 3Kitasato University School of Nursing, Sagamihara-city, Kanagawa, Japan; 4Kitasato University School of Medicine, Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Sagamihara-city, Kanagawa, JapanCorrespondence: Satoshi IgawaDepartment of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1, Kitasato, Minami-ku, Sagamihara-city, Kanagawa, 252-0374, JapanTel +81-42-778-8506Fax +81-42-778-6412Email igawa@kitasato-u.ac.jpBackground: The clinical outcomes of elderly patients with EGFR-mutated non-small cell lung cancer (NSCLC) who are treated with osimertinib have not been sufficiently evaluated. This study aimed to assess the efficacy and safety of osimertinib in elderly chemotherapy-naive patients with NSCLC harboring sensitive EGFR mutations.Patients and Methods: We assessed the clinical effects of osimertinib as a first-line treatment for elderly NSCLC patients (≥ 75 years of age) with an exon 19 deletion or exon 21 L858R mutation in EGFR. All patients were administered 80 mg/day osimertinib as initial treatment.Results: Forty-three patients (24 women and 19 men) with adenocarcinoma who were treated between August 2018 and July 2021 were included in this study; their median age was 79 years (range, 75– 90 years). The overall objective response rate was 60.5%. The median progression-free survival (PFS) and time to treatment failure (TTF) of the entire patient population were 22.1 months and 14.6 months, respectively. The most common adverse event was rash acneiform (42%), followed by diarrhea (33%) and paronychia (28%); none of these were grades ≥ 3. Interstitial lung disease developed in 8 patients (18.6%); however, no treatment-related deaths occurred. Multivariate analysis identified performance status and disease stage as predictors of PFS and TTF.Conclusion: Considering the findings of this study and despite an observed discordance between PFS and TTF, osimertinib appears to be an effective and safe treatment option in elderly patients with advanced NSCLC harboring sensitive EGFR mutations. To obtain conclusive results, further studies in a larger elderly population are warranted.Keywords: non-small cell lung carcinoma, chemotherapy-naïve patients, efficacy
format	article
author	Igawa S Kasajima M Ono T Ozawa T Kakegawa M Kusuhara S Sato T Nakahara Y Fukui T Yokoba M Kubota M Mitsufuji H Sasaki J Naoki K
author_facet	Igawa S Kasajima M Ono T Ozawa T Kakegawa M Kusuhara S Sato T Nakahara Y Fukui T Yokoba M Kubota M Mitsufuji H Sasaki J Naoki K
author_sort	Igawa S
title	A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer
title_short	A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer
title_full	A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer
title_fullStr	A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer
title_full_unstemmed	A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer
title_sort	prospective observational study of osimertinib for chemo-naive elderly patients with egfr mutation-positive non-small cell lung cancer
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/c4af3cf763734c538771c06213db5f99
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A Prospective Observational Study of Osimertinib for Chemo-Naive Elderly Patients with EGFR Mutation-Positive Non-Small Cell Lung Cancer

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