fulltext.pdf 504 KB
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.
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.
non-small-cell lung carcinoma
© 2020 The Authors.
|Web of Science KeyUT|