A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancer

Abstract Background Although the incidence of lung cancer in elderly individuals has been increasing in recent years, the number of clinical trials designed specifically for elderly patients with advanced non‐small cell lung cancer (NSCLC) is still limited. To fulfill this unmet medical need, we con...

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Main Authors: Yohei Yabuki, Masaki Hanibuchi, Eiji Takeuchi, Takashi Haku, Takanori Kanematsu, Naoki Nishimura, Yuko Toyoda, Atsushi Mitsuhashi, Kenji Otsuka, Seidai Sato, Hisatsugu Goto, Hiroto Yoneda, Hirokazu Ogino, Hiroshi Nokihara, Shinohara Tsutomu, Yasuhiko Nishioka
Format: Article
Language:English
Published: Wiley 2023-11-01
Series:Thoracic Cancer
Subjects:
Online Access:https://doi.org/10.1111/1759-7714.15115
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author Yohei Yabuki
Masaki Hanibuchi
Eiji Takeuchi
Takashi Haku
Takanori Kanematsu
Naoki Nishimura
Yuko Toyoda
Atsushi Mitsuhashi
Kenji Otsuka
Seidai Sato
Hisatsugu Goto
Hiroto Yoneda
Hirokazu Ogino
Hiroshi Nokihara
Shinohara Tsutomu
Yasuhiko Nishioka
author_facet Yohei Yabuki
Masaki Hanibuchi
Eiji Takeuchi
Takashi Haku
Takanori Kanematsu
Naoki Nishimura
Yuko Toyoda
Atsushi Mitsuhashi
Kenji Otsuka
Seidai Sato
Hisatsugu Goto
Hiroto Yoneda
Hirokazu Ogino
Hiroshi Nokihara
Shinohara Tsutomu
Yasuhiko Nishioka
author_sort Yohei Yabuki
collection DOAJ
description Abstract Background Although the incidence of lung cancer in elderly individuals has been increasing in recent years, the number of clinical trials designed specifically for elderly patients with advanced non‐small cell lung cancer (NSCLC) is still limited. To fulfill this unmet medical need, we conducted a phase II study to elucidate the efficacy of pemetrexed (PEM) plus bevacizumab (Bev) combination chemotherapy in elderly patients with nonsquamous NSCLC. Methods A total of 29 elderly patients (≥75 years old) with nonsquamous NSCLC were enrolled in this multicenter, open‐label, phase II study, and 27 patients were finally analyzed. PEM at 500 mg/m2 on day 1 plus Bev at 15 mg/kg on day 1 were administered triweekly. The primary endpoint was the investigator‐assessed objective response rate. Results The median age at initiating chemotherapy was 80 years old. Almost all patients (92.6%) had adenocarcinoma histology. The median number of cycles administered was 6, and the objective response rate was 40.7%. The median progression‐free survival, overall survival and 1‐year survival were 8.8 months, 27.2 months and 79%, respectively. The treatment was well‐tolerated, and no treatment‐related death was observed. Conclusion Combination chemotherapy with PEM plus Bev in elderly patients with previously untreated advanced non‐squamous NSCLC exhibited favorable antitumor activity and tolerability, suggesting that a combination of PEM plus Bev might be a promising treatment option for this population.
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spelling doaj.art-0bcc20ae3023490cbf17233bd45b1ae22023-11-14T05:52:29ZengWileyThoracic Cancer1759-77061759-77142023-11-0114323232323910.1111/1759-7714.15115A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancerYohei Yabuki0Masaki Hanibuchi1Eiji Takeuchi2Takashi Haku3Takanori Kanematsu4Naoki Nishimura5Yuko Toyoda6Atsushi Mitsuhashi7Kenji Otsuka8Seidai Sato9Hisatsugu Goto10Hiroto Yoneda11Hirokazu Ogino12Hiroshi Nokihara13Shinohara Tsutomu14Yasuhiko Nishioka15Department of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Community Medicine for Respirology, Hematology and Metabolism, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Clinical Investigation National Hospital Organization Kochi Hospital Kochi JapanDepartment of Respiratory Medicine Tokushima Prefectural Central Hospital Tokushima JapanDepartment of Respiratory Medicine Japanese Red Cross Matsuyama Hospital Matsuyama JapanDepartment of Pulmonary Medicine St. Luke's International Hospital Tokyo JapanDepartment of Internal Medicine Japanese Red Cross Kochi Hospital Kochi JapanDepartment of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Respiratory Medicine Center Hospital of the National Center for Global Health and Medicine Tokyo JapanDepartment of Community Medicine for Respirology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanDepartment of Respiratory Medicine and Rheumatology, Graduate School of Biomedical Sciences Tokushima University Tokushima JapanAbstract Background Although the incidence of lung cancer in elderly individuals has been increasing in recent years, the number of clinical trials designed specifically for elderly patients with advanced non‐small cell lung cancer (NSCLC) is still limited. To fulfill this unmet medical need, we conducted a phase II study to elucidate the efficacy of pemetrexed (PEM) plus bevacizumab (Bev) combination chemotherapy in elderly patients with nonsquamous NSCLC. Methods A total of 29 elderly patients (≥75 years old) with nonsquamous NSCLC were enrolled in this multicenter, open‐label, phase II study, and 27 patients were finally analyzed. PEM at 500 mg/m2 on day 1 plus Bev at 15 mg/kg on day 1 were administered triweekly. The primary endpoint was the investigator‐assessed objective response rate. Results The median age at initiating chemotherapy was 80 years old. Almost all patients (92.6%) had adenocarcinoma histology. The median number of cycles administered was 6, and the objective response rate was 40.7%. The median progression‐free survival, overall survival and 1‐year survival were 8.8 months, 27.2 months and 79%, respectively. The treatment was well‐tolerated, and no treatment‐related death was observed. Conclusion Combination chemotherapy with PEM plus Bev in elderly patients with previously untreated advanced non‐squamous NSCLC exhibited favorable antitumor activity and tolerability, suggesting that a combination of PEM plus Bev might be a promising treatment option for this population.https://doi.org/10.1111/1759-7714.15115bevacizumabelderly patientspemetrexedpreviously untreated nonsquamous non‐small cell lung cancer
spellingShingle Yohei Yabuki
Masaki Hanibuchi
Eiji Takeuchi
Takashi Haku
Takanori Kanematsu
Naoki Nishimura
Yuko Toyoda
Atsushi Mitsuhashi
Kenji Otsuka
Seidai Sato
Hisatsugu Goto
Hiroto Yoneda
Hirokazu Ogino
Hiroshi Nokihara
Shinohara Tsutomu
Yasuhiko Nishioka
A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancer
Thoracic Cancer
bevacizumab
elderly patients
pemetrexed
previously untreated nonsquamous non‐small cell lung cancer
title A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancer
title_full A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancer
title_fullStr A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancer
title_full_unstemmed A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancer
title_short A multicenter, open‐label, phase II trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non‐small cell lung cancer
title_sort multicenter open label phase ii trial of pemetrexed plus bevacizumab in elderly patients with previously untreated advanced or recurrent nonsquamous non small cell lung cancer
topic bevacizumab
elderly patients
pemetrexed
previously untreated nonsquamous non‐small cell lung cancer
url https://doi.org/10.1111/1759-7714.15115
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