Funding

This study was supported by Sanofi Co. Ltd.

Conflicts of Interest/Competing Interests

Toshihiko Matsumoto received research funding from Ono Pharmaceutical Co., Ltd and Sanofi Co., Ltd; honoraria from Bayer Co., Ltd, Bristol-Myers Squibb Co., Ltd, Chugai Pharmaceutical Co., Ltd, Daiichi Sankyo Co., Ltd, Eli Lilly Japan Co., Ltd, Merck Bio Pharma Co., Ltd, MSD Co., Ltd, Ono Pharmaceutical Co., Ltd, Sanofi Co, Ltd, Taiho Pharmaceutical Co., Ltd, Takeda Co., Ltd, Teijin Pharmaceutical Co., Ltd, and Yakult Honsha Co., Ltd. Yoshiyuki Yamamoto received honoraria for lectures from Sanofi Co. Ltd, Ltd, Nihon Kayaku, Eisai, Bayer Co., Ltd, Lilly, Taiho Pharmaceutical Co., Ltd, Daiichi Sankyo Co., Ltd, Yakult Honsha Co., Ltd, Nihon Servier, Asahi Kasei, and Ono Pharmaceutical Co., Ltd. Masahito Kotaka has received payment or honoraria for lectures, presentations, speaker’s bureau, manuscript writing, or educational events from Chugai Pharmaceutical Co. Ltd, Taiho Pharmaceutical Co., Ltd, and Yakult Honsha Co., Ltd. Toshiki Masuishi has received institutional grants or contracts from MSD, Daiichi Sankyo Co., Ltd, Ono Pharmaceutical Co., Ltd, and Novartis and personal consulting fees from Takeda Pharma, Chugai Pharmaceutical Co. Ltd, Merck Biopharma, Taiho Pharmaceutical Co., Ltd, Bayer, Eli Lilly Japan, Yakult Honsha Co., Ltd, Sanofi Co. Ltd, Daiichi Sankyo Co., Ltd, Ono Pharmaceutical Co., Ltd, and Bristol Myers Squibb. Hirokazu Shoji has received honoraria from Ono Pharmaceutical Co., Ltd and Zymeworks Inc.; has been on advisory boards for Personal Amgen, Astellas, Daiichi Sankyo Co., Ltd, MSD, and Takeda Pharma; and a local PI. Akitaka Makiyama has received honoraria from Eli Lilly Japan K.K., Taiho Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb Co. Ltd., and Daiichi Sankyo Co. Ltd. Naoki Takahashi has received honoraria from Ono Pharmaceutical Co, Ltd, Taiho Pharmaceutical Co. Ltd, and Bristol Myers Squibb. Takashi Ohta has received honoraria from Eli Lilly, Bristol-Myers Squibb K.K., Taiho Pharmaceutical Co. Ltd, Ono Pharmaceutical Co., Ltd, 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. Yosuke Kito has received honoraria from Taiho Pharmaceutical Co. Ltd, Ono Pharmaceutical Co., Ltd, and Daiichi Sankyo Co., Ltd. Narikazu Boku has received lecture fees or honoraria from Bristol-Myers Squibb, Daiichi-Sankyo Co., Ltd, Ono Pharmaceutical Co., Ltd, and Taiho Pharmaceutical Co. Ltd, and research funds from Ono Pharmaceutical Co., Ltd and Takeda. Kentaro Yamazaki has received honoraria for lectures from Chugai Pharmaceutical Co., Ltd., Yakult Honsha Co., Ltd., Daiichi Sankyo Co., Ltd., Merck Biopharma Co., Ltd., Sanofi K.K., MSD K.K., Takeda Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K, Ono Pharmaceutical Co., Ltd., and Bristol-Myers Squibb K.K. Shuichi Hironaka has received lecture fees or honoraria from Taiho Pharmaceutical Co., Ltd. Kei Muro has received lecture fees or honoraria from Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Bristol-Myers Squibb Co., Ltd., Eli Lilly Japan K.K., MSD K.K., Takeda Pharmaceutical Co., Ltd., Daiichi-Sankyo Co., Ltd, and Taiho Pharmaceutical Co. Ltd; research funds from Chugai Pharmaceutical Co., Ltd., MSD K.K., Amgen K.K., Ono Pharmaceutical Co., Ltd., Astellas Pharma Inc., Sanofi Co., Ltd., Taiho Pharmaceutical Co. Ltd., Eisai Co., Ltd., Daiichi-Sankyo Co. Ltd., Novartis Pharma K.K., and Pfizer Japan Inc., and has been an advisor for AstraZeneca K.K., Ono Pharmaceutical Co., Ltd., and Amgen K.K. Yasushi Tsuji, Kenro Hirata, Takao Tsuduki, Naoki Izawa, Masahiro Tsuda, Hisateru Yasui, Satoshi Otsu, Ichinosuke Hyodo, and Kenichi Yoshimura have no conflicts of interest that are directly relevant to the content of this article.

Ethics Approval

This study was approved by the certified Review Board of Aichi Cancer Center Hospital and has been registered in the Japan Registry of Clinical Trials (jRCTs041190100).

Consent to Participate

Written informed consent was obtained from all patients before study enrollment.

Consent for Publication

Not applicable.

Availability of Data and Material

Not applicable.

Code Availability

Not applicable.

Authors’ Contributions

Study concept—TM, KY, and KM. Study design—TM, KY and KM. Acquisition, analysis, or interpretation of data—All authors. Statistical analysis—NI and KY. Manuscript preparation—TM, NI, SH, NB and IH. Manuscript editing and revision—All authors. Manuscript review and approval—All authors.