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Article History

Received: 29 January 2023

Revised: 3 July 2023

Accepted: 24 July 2023

First Online: 2 August 2023

Competing interests

: KA, MS, KO and YM declare no conflict of interest. YN received honoraria for lectures from Chugai Pharmaceutical Co., Ltd., Merck Biopharma, and Guardant Health AMEA and research grants from Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Daiichi Sankyo Co., Ltd., Guardant Health, Genomedia, Seagen, and Roche Diagnostics. H Kitao received research funding from Taiho Pharmaceutical Co. Ltd. DK received honoraria for lectures from Takeda, Chugai, Eli Lilly, MSD, Ono, Taiho, Bristol Myers Squibb, Daiichi-Sankyo, Pfizer, Eisai, Merckbiopharma and Sysmex, and research funding from Ono, MSD, Novartis, Servier, Janssen, IQVIA, Syneos health, Cimic and Cimicshiftzero. HB received research funding from Ono, and honoraria for lectures from Ono, Taiho and Eli Lilly. TN received honoraria for lectures from Taiho Pharmaceutical, Chugai, Ono Pharmaceutical, Bristol-Meyers Squibb and Lilly; and research funding from Taiho Pharmaceutical, Chugai, Daiichi Sankyo, MSD, Ono Pharmaceutical, Bristol-Meyers Squibb, Lilly and Sumitomo Dainippon Pharma. TY received honoraria for lectures from Ono Pharmaceutical, Taiho Pharmaceutical, Johnson and Johnson, and Bristol-Myers Squibb K.K. SY received honoraria for lectures from Eli Lilly Japan K.K., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd., MSD K.K., Ono Phermaceutical Co., Ltd., Merck Biopharma Co., Ltd., Daiichi Sankyo Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., and Bristol-Myers Squibb K.K. YN received research funding from Chugai, MSD, Amgen, ONO Pharmaceutical, Astellas, Sanofi, Taiho, Eisai, Daiichi Sankyo, Novartis, Pfizer; Honoraria for lectures, presentations, and speakers’ bureaus from Yakult Honsha, Taiho, Eli Lilly, Daiichi Sankyo, Ono Pharma, Bristol-Mayers Squibb; Participation on an Advisory Board of Daiichi Sankyo. HH received honoraria from Bayer, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Kyowa Hakko Kirin, Lilly, Merck Biopharma, MSD, Ono, Taiho, Takeda and Yakult, consulting or advisory roles Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Dainippon Sumitomo, MSD and Ono, and research grants from ALX oncology, Amgen, Astellas, AstraZeneca, Bayer, BeiGene, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, Janssen, Merck Biopharma, MSD, Ono and Taiho. TO received honoraria for lectures from Eli Lilly, Bristol-Myers Squibb K.K., Taiho Pharmaceutical, Ono Pharmaceutical, Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Takeda Pharmaceutical Co., Ltd., Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Otsuka Pharmaceutical Co., Ltd., EA Pharma Co., Ltd. and Merck & Co., Inc., and research grants from Takeda Pharmaceutical Co., Ltd. TE. received honoraria for lectures from Daiichi Sankyo, Taiho and Chugai; and research funding from Novartis, Ono Pharmaceutical, Daiichi Sankyo, MSD, Astellas, Amgen Astellas BioPharma, IQVIA, Chugai, Pfyzer, Quitiles, Asahikasei Pharma and Syneos Health. YH received honoraria for lectures from Ono Pharmaceutical. KK received consulting fees from Daiichi-Sankyo, Seagen and Servier, honoraria for lectures from Ono Pharmaceutical, Bristol Myers Squibb, MSD and Taiho, research funding from Ono Pharmaceutical, Bristol Myers Squibb, MSD, Shionogi, Chugai, AstraZeneca, Janssen, Bayer, Merck Bio, Oncolys Biopharma and Beigene. YY received honoraria for lectures from Taiho Pharmaceutical, Ono Pharmaceutical, Asahi Kasei, Sanofi, Nihonkayaku, Merck Serono and Yakult, Eisai. KM received research grant from Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., MSD K.K, Astellas, BeiGene and Daiichi Sankyo Co., Ltd. NI received honoraria for lectures from Bristol-Myers Squibb K.K., Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., and MSD K.K. HK received honoraria for lectures from Bristol-Myers Squibb Co. Ltd., Eli Lilly Japan K.K., MSD K.K., Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Merck Biopharma Co., Ltd., Takeda Pharmaceutical Co. Ltd., Yakult Pharmaceutical Industry, Teijin Pharma Ltd., Incyte Biosciences Japan., and Taiho Pharmaceutical Co. Ltd.; lecture fees from Glaxo Smith Kline K.K., and Otsuka Pharmaceutical Co., Ltd.; and research funding from Kobayashi Pharmaceutical. Co., Ltd., and Eisai Co. Ltd. TK received honoraria for lectures from Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Yakult Honsha Co., Ltd., and Taiho Pharmaceutical Co., Ltd., and research grants from Chugai Pharmaceutical Co., Ltd. TS received honoraria for lectures from Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Bristol-Myers Squibb K.K., Taiho Pharmaceutical Co., Ltd., and Daiichi Sankyo Co., Ltd., research grants from Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Bristol-Myers Squibb K.K., Taiho Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., MSD K.K., Gilead Sciences, Inc., and Parexel International Corporation, scholarship grants from Taiho Pharmaceutical Co., Ltd., and Daiichi Sankyo Co., Ltd., and endowed chair from Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., and Yakult Honsha Co., Ltd. NO received honoraria for lectures from Ono Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Taiho Pharmaceutical Co., Ltd., and Daiichi Sankyo Co., Ltd., Takeda Pharmaceutical Co., Ltd. Bayer Yakuhin, Ltd. and Eisai Co., Ltd; and advisory board from GlaxoSmithKline CO., Ltd. AT received speakers’ bureaux with Taiho Pharmaceutical, Chugai, Eli Lilly Japan, Merck Serono, Sanofi and Bristol-Myers Squibb; and research funding from Taiho Pharmaceutical, Sanofi and Ono Pharmaceutical. KY received honoraria for lectures from Chugai Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Co., Ltd. TY received honoraria for lectures from Chugai Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., Bayer Yakuhin, Ltd., MSD K.K., and Ono Pharmaceutical Co., Ltd., and research grants from MSD K.K., Ono Pharmaceutical Co., Ltd., Sanofi K.K., Daiichi Sankyo Co., Ltd., Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Amgen K.K., Eisai Co., Ltd., FALCO biosystems Ltd., Genomedia Inc., Molecular Health GmbH, Nippon Boehringer Ingelheim Co., Ltd., Pfizer Japan Inc., Roche Diagnostics K., Sysmex Corp., and Sysmex Corp. EO received research funding from Guardant Health, and honoraria for lectures from Ono, Takeda, Bayer, Chugai, Taiho, Eli Lilly and Bristol Myers Squibb.

: The ethical, medical, and scientific aspects of the study were reviewed and approved by the Institutional Review Board of each institution and registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN000016344). This study was conducted in accordance with the Declaration of Helsinki, revised in 2000, and the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects.