Haratani, Koji http://orcid.org/0000-0002-1767-6854
Nakamura, Atsushi
Mamesaya, Nobuaki
Sawa, Kenji
Shiraishi, Yoshimasa
Saito, Ryota
Tanizaki, Junko
Tamura, Yosuke
Hata, Akito
Tsuruno, Kosuke
Sakamoto, Tomohiro
Teraoka, Shunsuke
Oki, Masahide
Watanabe, Hiroshi
Tokito, Takaaki
Nagata, Kenji
Masuda, Takeshi
Nakamura, Yasushi
Sakai, Kazuko
Chiba, Yasutaka
Ito, Akihiko http://orcid.org/0000-0003-1411-4001
Nishio, Kazuto http://orcid.org/0000-0002-8275-0846
Yamamoto, Nobuyuki
Nakagawa, Kazuhiko
Hayashi, Hidetoshi http://orcid.org/0000-0001-8787-5587
Funding for this research was provided by:
AstraZeneca (ESR-18-13940)
Article History
Received: 3 September 2023
Revised: 12 March 2024
Accepted: 14 March 2024
First Online: 22 March 2024
Competing interests
: K Haratani has received lecture fees or honoraria from AS ONE Corporation, Bristol-Myers Squibb Co. Ltd., MSD K.K., and Ono Pharmaceutical Co. Ltd.; and research funding from AstraZeneca K.K., and MSD K.K. A Nakamura has received lecture fees or honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Nippon Kayaku Co. Ltd., Novartis Pharma K.K., Taiho Pharmaceutical Co. Ltd., and Thermo Fisher Scientific Inc. K Sawa has received lecture fees or honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Kyowa Kirin Co. Ltd., Nippon Boehringer Ingelheim Co. Ltd., Ono Pharmaceutical Co. Ltd., and Taiho Pharmaceutical Co. Ltd. Y Shiraishi has received lecture fees or honoraria from AstraZeneca K.K., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., and Taiho Pharmaceutical Co. Ltd.; and research funding from Chugai Pharmaceutical Co. Ltd. J Tanizaki has received lecture fees or honoraria from AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Nihon Medi-Physics Co. Ltd., Nippon Kayaku Co. Ltd., Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., and Taiho Pharmaceutical Co. Ltd. A Hata has received lecture fees or honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Nippon Kayaku Co. Ltd., Pfizer Inc., and Taiho Pharmaceutical Co. Ltd.; and research funding from MSD K.K., Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co. Ltd., and AstraZeneca K.K. T Sakamoto has received lecture fees or honoraria from AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Hisamitsu Pharmaceutical Co. Inc., Illumina K.K., Janssen Pharmaceutical K.K., Kyowa Kirin Co., Ltd., Merck KGaA, MSD K.K., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., Taiho Pharmaceutical Co. Ltd., and Takeda Pharmaceutical Co., Ltd. S Teraoka has received lecture fees or honoraria from AstraZeneca K.K. Boehringer Ingelheim Japan Inc., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Pfizer R&D Japan G.K., and Taiho Pharmaceutical Co. Ltd.; and advisory board fees from Pfizer R&D Japan G.K. S Teraoka is currently an employee of AstraZeneca K.K. M. Oki has received lecture fees or honoraria from AMCO Inc., AstraZeneca K.K., Canon Medical Systems Corporation., Chugai Pharmaceutical Co. Ltd., Fujifilm Toyama Chemical Co. Ltd., Kaneka Medix Corp., Merit Medical Japan K.K., Novartis Pharma K.K., Olympus Corporation, and Sanofi K.K.; and research funding from AbbVie Inc., AstraZeneca K.K., Chugai Pharmaceutical Co. Ltd., Fujifilm Toyama Chemical Co. Ltd., GlaxoSmithKline K.K., Janssen Pharmaceutical K.K., MSD K.K., Ono Pharmaceutical Co. Ltd., Parxel International Corporation, Pfizer Japan Inc., and Sanofi K.K. Takaaki Tokito has received lecture fees or honoraria from AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., MSD K.K., Nippon Kayaku Co. Ltd., Novartis Pharma K.K., and Ono Pharmaceutical Co. Ltd. Takeshi Masuda has received lecture fees or honoraria from AstraZeneca K.K., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Eli Lilly Japan K.K., Kyowa Kirin Co. Ltd., MSD K.K., Ono Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., and Taiho Pharmaceutical Co. Ltd.; and research funding from MSD K.K. Yasushi Nakamura has received consulting fees from LSI Medience Corporation., and Nikon Corporation.; and advisory fees from Agilent Technologies Inc. K Sakai has received lecture fees or honoraria from Chugai Pharmaceutical Co. Ltd., Hitachi Ltd., Life Technologies Corporation, Takeda Pharmaceutical Co. Ltd., and Yodosha Co. Ltd. Y Chiba has received lecture fees or honoraria from Chugai Pharmaceutical Co. Ltd. K. Nishio has received research funding from Clinical Research Support Center Kyushu, Eli Lilly Japan K.K., Hitachi Ltd., Nichirei Biosciences Inc., Nippon Boehringer Ingelheim Co. Ltd., North East Japan Study Group, Otsuka Pharmaceutical Co. Ltd., Sysmex Corporation, Thoracic Oncology Research Group and West Japan Oncology Group. N Yamamoto has received lecture fees or honoraria from Amgen Inc., AstraZeneca K.K., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eli Lilly Japan K.K., GlaxoSmithKline K.K., Guardant Health Japan Corp., Janssen Pharmaceutical K.K., Kyorin Pharmaceutical Co. Ltd., Kyowa Kirin Co. Ltd., Merck kGaA, MIYARISAN Pharmaceutical Co,, MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Nippon Kayaku Co. Ltd., Novartis Pharma K.K., Ono Pfizer Japan Inc., Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., Sanofi K.K., Taiho Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., and TSUMURA & CO.; and advisory board fees from AstraZeneca K.K., Eli Lilly Japan K.K., and Takeda Pharmaceutical Co. Ltd.; and research funding from AbbVie Inc., Amgen Inc., Asahi Kasei Pharma Corporation, Astellas Pharma Inc., AstraZeneca K.K., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., Eli Lilly Japan K.K., Janssen Pharmaceutical K.K., MSD K.K., Nippon Boehringer Ingelheim Co. Ltd., Nippon Kayaku Co. Ltd., Nobelpharma Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., Pfizer Japan Inc., Sanofi K.K., Shionogi & Co. Ltd., Taiho Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., TOSOH CORPORATION. and TSUMURA & CO. K. Nakagawa has received lecture fees or honoraria from AstraZeneca K.K., Amgen Inc., Bayer Yakuhin Ltd., Care Net Inc., Chugai Pharmaceutical Co. Ltd., CMIC Co. Ltd., CMIC ShiftZero K.K., Eli Lilly Japan K.K., Japan Clinical Research Operations, Kyowa Kirin Co. Ltd., Life Technologies Japan Ltd., Merck Biopharma Co. Ltd., Medical Mobile Communications Co. Ltd, Medical Review Co. Ltd., MSD K.K., Nikkei Business Publications Inc., Nippon Boehringer Ingelheim Co. Ltd., Nippon Kayaku Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Pfizer Japan Inc., Taiho Pharmaceutical Co. Ltd., TAIYO Pharma Co. Ltd., Takeda Pharmaceutical Co. Ltd., Yodosya Co. Ltd., and 3H Clinical Trial Inc.; and consulting fees from Eli Lilly Japan K.K., and Ono Pharmaceutical Co. Ltd.; and research funding from Amgen Inc., AstraZeneca K.K., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Covance Japan Inc., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., Eli Lilly Japan K.K., EP-CRSU Co. Ltd., EPS Corporation, EPS International Co. Ltd., GlaxoSmithKline K.K., IQVIA Services JAPAN K.K., Janssen Pharmaceutical K.K., Japan Clinical Research Operations, Kissei Pharmaceutical Co. Ltd., Mebix Inc., Medical Research Support, MSD K.K., Mochida Pharmaceutical Co. Ltd., Nippon Boehringer Ingelheim Co. Ltd., Nippon Kayaku Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., PAREXEL International Corp., PPD-SNBL K.K., PRA Health Sciences., Sanofi K.K., SRL Inc., SymBio Pharmaceuticals Limited., Syneos Health Clinical K.K., Sysmex Corporation., Taiho Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd.; and has patents pending with Daiichi Sankyo Co. Ltd. H. Hayashi has received lecture fees or honoraria from Amgen K.K., AstraZeneca K.K., Boehringer Ingelheim Japan Inc., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eli Lilly Japan K.K., Guardant health Inc., Kyorin Pharmaceutical Co. Ltd., Merck Biopharma Co. Ltd., MSD K.K., Novartis Pharmaceuticals K.K., Ono Pharmaceutical Co. Ltd., Shanghai Haihe Biopharm, Taiho Pharmaceutical Co. Ltd., Pfizer Japan Inc., and Takeda Pharmaceutical Co. Ltd.; and research funding from AbbVie Inc, Astellas Pharma Inc., AstraZeneca K.K., A2 Healthcare Corp., Bayer Yakuhin Ltd., Bristol-Myers Squibb Co. Ltd., Chugai Pharmaceutical Co. Ltd., CMIC ShiftZero K.K., Daiichi Sankyo Co. Ltd., Eisai Co. Ltd., Eli Lilly Japan K.K., EP-CRSU Co. Ltd., EPS Corporation., EPS International Co. Ltd., GRITSONE ONCOLOGY INC., ICON Japan K.K., inVentiv Health Japan, IQVIA Services JAPAN K.K., Kissei Pharmaceutical Co. Ltd., Kyowa Hakko Kirin Co. Ltd, Merck Biopharma Co. Ltd., Merck Serono Co. Ltd., MSD K.K., Linical Co. Ltd., Nippon Boehringer Ingelheim Co. Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co. Ltd., Otsuka Pharmaceutical Co. Ltd., PAREXEL International Corp., Pfizer Japan Inc., Pfizer R&D Japan G.K., SymBio Pharmaceuticals Limited., Quintiles Inc., Syneos Health, Taiho Pharmaceutical Co. Ltd., and Takeda Pharmaceutical Co. Ltd. All other authors declare competing interests.
: This study was performed in accordance with the protocol and the Declaration of Helsinki. The full protocol and informed consent form were approved by the ethics committee of each institution. All participants provided written consent before study entry.
: Not applicable.