Umemoto, Kumiko http://orcid.org/0000-0001-8901-7332
Sunakawa, Yu http://orcid.org/0000-0002-0163-7543
Ueno, Makoto http://orcid.org/0000-0003-4480-0029
Furukawa, Masayuki
Mizuno, Nobumasa
Sudo, Kentaro
Kawamoto, Yasuyuki http://orcid.org/0000-0002-7706-0015
Kajiwara, Takeshi http://orcid.org/0000-0001-5337-9833
Ohtsubo, Koushiro
Okano, Naohiro
Matsuhashi, Nobuhisa
Itoh, Shinji
Matsumoto, Toshihiko
Shimizu, Satoshi
Otsuru, Toru
Hasegawa, Hiroko
Okuyama, Hiroyuki
Ohama, Hideko
Moriwaki, Toshikazu http://orcid.org/0000-0001-7702-122X
Ohta, Takashi
Odegaard, Justin I.
Nakamura, Yoshiaki
Bando, Hideaki
Yoshino, Takayuki http://orcid.org/0000-0002-0489-4756
Ikeda, Masafumi http://orcid.org/0000-0002-4050-2086
Morizane, Chigusa
Article History
Received: 14 October 2022
Revised: 24 January 2023
Accepted: 26 January 2023
First Online: 13 February 2023
Competing interests
: MF, KO, N Matsuhashi, SI, T Matsumoto, T Otsuru, HH, H Okuyama and H Ohama have nothing to disclose. KU reports honoraria from Chugai Pharmaceutical, Taiho Pharmaceutical and Yakult Honsha. YS reports honoraria from Takeda Pharmaceutical, Eli Lilly Japan, Chugai Pharmaceutical, Taiho Pharmaceutical, Bristol-Myers Squibb, Ono Pharmaceutical, Bayer, Daiichi Sankyo and Merck Biopharma; and grants from IQVIA and Parexel; and contributions or endowed chair from Takeda Pharmaceutical, Taiho Pharmaceutical, Chugai Pharmaceutical, Eli Lilly Japan, Sanofi and EN Otsuka Pharma. MU reports grants and personal fees from Taiho Pharmaceutical, AstraZeneca, Merck Biopharma, MSD, Ono Pharmaceutical, Incyte Corporation and Chugai Pharmaceutical; and personal fees from Nihon Servier; and grants from Astellas Pharma, Eisai and DFP. N Mizuno reports grants and personal fees from AstraZeneca, Novartis, Yakult Honsha, Ono Pharmaceutical, Taiho Pharmaceutical; and grants from MSD, Dainippon Sumitomo Pharma, ASLAN Pharmaceuticals, Incyte Corporation. and Seagen; and personal fees from Teijin Pharma, FUJIFILM Toyama Chemical, outside the submitted work. KS reports honoraria from Ono Pharmaceutical and Yakult Honsha; and grants (for the institution) from Bristol-Myers Squibb/Ono Pharmaceutical, Eisai and Incyte corporation. YK reports honoraria from Taiho Pharmaceutical, Incyte, Merck Biopharma, Yakult Honsha, and Eli Lilly; and grants from Takeda Pharmaceutical. TK reports honoraria from Taiho Pharmaceutical, Chugai Pharmaceutical, Ono Pharmaceutical and Eli Lilly. NO reports honoraria from Taiho Pharmaceutical, Eli Lilly, Eisai, Bayer Yakuhin, Chugai Pharmaceutical, Ono Pharmaceutical and Takeda Pharmaceutical; and advisory board from GlaxoSmithKline. SS reports grants from AstraZeneca, Incyte Corporation and Delta-Fly Pharma. T Moriwaki reports honoraria from Taiho Pharmaceutical, Eli Lilly Japan, Takeda Pharmaceutical, Chugai Pharmaceutical, Sanofi, Bayer Yakuhin, Merck Biopharma, Ono Pharmaceutical and Yakult Honsha; and grants from Taiho Pharmaceutical, MSD, Takeda Pharmaceutical, and Yakult Honsha. T Ohta reports honoraria from Chugai Pharmaceutical, Teijin Pharma, Takeda Pharmaceutical, Eisai, Yakult-Honsha, Daiichi Sankyo, Merck Biopharma, Ono Pharmaceutical, Taiho Pharmaceutical and Bristol-Myers Squibb; and grants from Takeda Pharmaceutical. JIO reports from, and stock interests in, Guardant Health. YN reports grants from Taiho Pharmaceutical, Chugai Pharmaceutical, Guardant Health, Genomedia, Daiichi Sankyo, Seagen, Roche Diagnostics. HB reports honoraria from Taiho Pharmaceutical, Eli Lilly Japan, Ono Pharmaceutical; and grants from Ono Pharmaceutical outside the submitted work. TY reports honoraria from Taiho Pharmaceutical, Chugai Pharmaceutical, Eli Lilly, Merck Biopharma, Bayer Yakuhin, Ono Pharmaceutical and MSD; and grants from Ono Pharmaceutical, Sanofi, Daiichi Sankyo, Parexel International, Pfizer Japan, Taiho Pharmaceutical, MSD, Amgen, Genomedia, Sysmex, Chugai Pharmaceutical and Nippon Boehringer Ingelheim. MI reports honoraria from Bayer, Bristol-Myers Squibb, Eli Lilly, Eisai, Sumitomo Dainippon Pharma, EA Pharma, Teijin Pharma, Yakult Honsha, Taiho Pharmaceutical, Otsuka, MSD, Mylan, Nihon Servier, Chugai Pharmaceutical, AstraZeneca, AbbVie, Abbott, Takeda, Novartis and Astellas Pharma; and advisory roles with Bayer, Eli Lilly, Eisai, Chugai Pharmaceutical, AstraZeneca, Takeda Pharmaceutical, Ono Pharmaceutical, GlaxoSmithKline and Nihon Servier; and grants from Bayer, Bristol-Myers Squibb, Eli Lilly, Eisai, Takeda Pharmaceutical, AstraZeneca, Chugai Pharmaceutical, Merck Biopharma, ASLAN Pharmaceuticals, Novartis, Yakult Honsha, Taiho Pharmaceutical, Ono Pharmaceutical, MSD, Merus N.V., Nihon Servier, Pfizer, Chiome Bioscience, Delta-Fly Pharma, and J-Pharma. CM reports honoraria from Nihon Servier, Novartis, Yakult Honsha, Teijin Pharma, Taiho Pharmaceutical, Eisai and MSD; advisory roles with Yakult Honsha, Novartis, Servier, Taiho Pharmaceutical and Abbvie; and grants from Eisai, Yakult Honsha, Ono Pharmaceutical, Taiho Pharmaceutical, J-Pharma, Daiichi Sankyo, HITACHI, AstraZeneca and Merck Biopharma.
: The study was conducted in accordance with the Declaration of Helsinki and the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects. The protocol of the GOZILA study was approved by the institutional review board of each participating institution and registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (protocol no. UMIN000029315 for GOZILA.
: This manuscript does not contain any individual person’s data such as individual details, images or videos.