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First Online: 22 September 2020

Declarations

:

: Conception and design: Kohei Shitara, Kimio Yonesaka. Provision of study materials or patients: All authors. Collection and assembly of data: All authors. Data analysis and interpretation: Naoki Izawa, Takeharu Yamanaka. Manuscript writing: All authors. Final approval of manuscript: All authors.

: This work was supported by the Japan Agency for Medical Research and Development (grant numbers 961928, 965308).

: Author K.S. has received consulting or advisory roles for Astellas, Lilly, Bristol-Myers Squibb, Takeda, Pfizer, Ono, MSD, Taiho, Novartis, AbbVie, and GlaxoSmithKline; honoraria from Novartis, AbbVie, and Yakult; research funding from Astellas, Lilly, Ono, Sumoitomo Dainippon, Daiichi Sankyo, Taiho, Chugai, MSD and Medi Science. Author T.M. has received honoraria from Takeda, Chugai, Merck Serono, Taiho, Bayer, Lilly Japan, Yakult Honsha and Sanofi; research funding from MSD, Daiichi Sankyo, and Ono. Author Y.S. has received consulting fees from Takeda Pharmaceutical and Daiichi Sankyo; honoraria form Takeda Pharmaceutical Taiho Pharmaceutical, Chugai Pharma, Yakult Honsha, Sanofi, Bayer Yakuhin, Bristol-Myers Squibb Japan, Merck Biopharma, Lilly Japan, Nippon Kayaku, and Kyowa Kirin. Author T.D. has received personal fees from SAWAI Pharmaceutical Co and Sysmex; grants from MSD and Ono Pharmaceutical. Author H.B. has received grants form Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Merck Biopharma Co., Ltd., and MSD K.K; payment for lectures including service on speaker bureaus from Eli Lilly Japan K.K., Taiho Pharmaceutical Co., Ltd., and Ono Pharmaceutical Co., Ltd. Author T.Y. has received grants form Novartis Pharma K.K., MSD.K.K., Sumitomo Dainippon pharma Co., Ltd., Chugai Pharmaceutical Co., Ltd., Sanofi K.K., Co., Ltd., and GlaxoSmithKline K.K. Author A.M. has received honoraria form Lilly, Chugai and Takeda Daiichi Sankyo Company, Limited, Parexel International Inc., Ono Pharmaceutical. Author I.H. has received grants and personal fees form Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb Co., Eli Lilly Japan, Asahi Kasei Pharma Corp., and Takeda Pharmaceutical Co., Ltd. The other authors have declared no conflicts of interest.

: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of University St. Marianna University School of Medicine (29 March 2018, No. 3933).

: Informed consent was obtained from all individual participants included in WJOG6210G trial. We provided participating subjects with the opportunity to opt out on-line from the study.

: Informed consent was obtained from all individual participants included in WJOG6210G trial. We provided participated patients with the opportunity to opt out on-line from the study.

: Individual participant data were extracted from the database of the WJOG6210G trial.

: Not applicable.