ID | 60827 |
FullText URL | |
Author |
Satouchi, Miyako
Department of Thoracic Oncology, Hyogo Cancer Center
Nosaki, Kaname
Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center
Takahashi, Toshiaki
Division of Thoracic Oncology, Shizuoka Cancer Center
Nakagawa, Kazuhiko
Department of Medical Oncology, Kindai University Faculty of Medicine
Aoe, Keisuke
Department of Medical Oncology, National Hospital Organization Yamaguchi Ube Medical Center
Kurata, Takayasu
Department of Thoracic Oncology, Kansai Medical University
Sekine, Akimasa
Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center
Horiike, Atsushi
Department of Thoracic Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Fukuhara, Tatsuro
Department of Respiratory Medicine, Miyagi Cancer Center
Sugawara, Shunichi
Department of Pulmonary Medicine, Sendai Kousei Hospital
Umemura, Shigeki
Department of Thoracic Oncology, National Cancer Center Hospital East
Saka, Hideo
Department of Respiratory Medicine and Medical Oncology, National Hospital Organization Nagoya Medical Center
Okamoto, Isamu
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University
Yamamoto, Nobuyuki
Internal Medicine III, Wakayama Medical University
Sakai, Hiroshi
Department of Thoracic Oncology, Saitama Cancer Center
Kishi, Kazuma
Department of Respiratory Medicine, Respiratory Center, Totanomon Hospital
Katakami, Nobuyuki
Division of Integrated Oncology, Institute of Biomedical Research and Innovation Hospital
Horinouchi, Hidehito
Department of Thoracic Oncology, National Cancer Center Hospital
Hida, Toyoaki
Department of Thoracic Oncology, Aichi Cancer Center
Okamoto, Hiroaki
Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen’s Hospital
Atagi, Shinji
Department of Thoracic Oncology, National Hospital Organization Kinki-Chuo Chest Medical Center
Ohira, Tatsuo
Department of Surgery, Tokyo Medical University
Han, Shi Rong
MSD, K.K.
Noguchi, Kazuo
MSD, K.K.
Ebiana, Victoria
Merck & Co., Inc.
Hotta, Katsuyuki
Center for Innovative Clinical Medicine, Okayama University Hospital
Kaken ID
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Abstract | This prespecified subanalysis of the global, randomized controlled phase III KEYNOTE‐024 study of pembrolizumab vs chemotherapy in previously untreated metastatic non‐small‐cell lung cancer without EGFR/ALK alterations and a programmed death ligand 1 (PD‐L1) tumor proportion score of 50% or higher evaluated clinical outcomes among patients enrolled in Japan. Treatment consisted of pembrolizumab 200 mg every 3 weeks (35 cycles) or platinum‐based chemotherapy (four to six cycles). The primary end‐point was progression‐free survival; secondary end‐points included overall survival and safety. Of 305 patients randomized in KEYNOTE‐024 overall, 40 patients were enrolled in Japan (all received treatment: pembrolizumab, n = 21; chemotherapy, n = 19). Median progression‐free survival was 41.4 (95% confidence interval [CI], 4.2‐42.5) months with pembrolizumab and 4.1 (95% CI, 2.8‐8.3) months with chemotherapy (hazard ratio [HR], 0.27 [95% CI, 0.11‐0.65]; one‐sided, nominal P = .001). Median overall survival was not reached (NR) (95% CI, 22.9‒NR) and 21.5 (95% CI, 5.2‐35.0) months, respectively (HR, 0.39 [95% CI, 0.17‐0.91]; one‐sided, nominal P = .012). Treatment‐related adverse events occurred in 21/21 (100%) pembrolizumab‐treated and 18/19 (95%) chemotherapy‐treated patients; eight patients (38%) and nine patients (47%), respectively, had grade 3‐5 events. Immune‐mediated adverse events and infusion reactions occurred in 11 pembrolizumab‐treated patients (52%) and four chemotherapy‐treated patients (21%), respectively; four patients (19%) and one patient (5%), respectively, had grade 3‐5 events. Consistent with results from KEYNOTE‐024 overall, first‐line pembrolizumab improved progression‐free survival and overall survival vs chemotherapy with manageable safety among Japanese patients with metastatic non‐small‐cell lung cancer without EGFR/ALK alterations and a PD‐L1 tumor proportion score of 50% or higher. The trial is registered with Clinicaltrials.gov: NCT02142738.
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Keywords | Japan
non-small-cell lung carcinoma
PD-L1 protein
pembrolizumab
treatment outcome
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Published Date | 2020-09-14
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Publication Title |
Cancer Science
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Volume | volume111
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Issue | issue12
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Publisher | Wiley
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Start Page | 4480
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End Page | 4489
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ISSN | 1347-9032
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NCID | AA11808050
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Content Type |
Journal Article
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language |
English
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OAI-PMH Set |
岡山大学
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Copyright Holders | © 2020 The Authors.
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File Version | publisher
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DOI | |
Web of Science KeyUT | |
Related Url | isVersionOf https://doi.org/10.1111/cas.14647
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License | https://creativecommons.org/licenses/by-nc-nd/4.0/
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