Funding for this research was provided by:
Taiho Pharmaceutical (KSCC1301)
Received: 30 September 2020
Accepted: 23 December 2020
First Online: 5 January 2021
Ethics approval and consent to participate
: This study was conducted in accordance with the Declaration of Helsinki and Ethical Guidelines for Clinical Studies in Japan, and the protocol was approved by the institutional review boards of all participating medical institutions; Tokyo Medical University Hospital, Dokkyo Medical University Hospital, Kyushu University Hospital, Kurume University, Hyogo Prefectural Cancer Center, Kagoshima University Hospital, Nagoya University Hospital, Fukuoka City Hospital, Nagasaki University Hospital, Kagoshima Kouseiren Hospital, Kitaharima General Medical Center, Saieikai Karatsu Hospital, Toho University Ohmori Hospital, Kumamoto University, JCHO Hitoyoshi Medical Center, Kyushu Medical Center, Kakizoe Hospital, Oita University Hospital, Iizuka Hospital, Okayama Rosai Hospital, St Marianna University School of Medicine, Sasebo City General Hospital, Aichi Prefectural Cancer Center Hospital, Oita Medical Center, Saieikai Sendai Hospital, Kumamoto Medical Center, Imari Arita Kyouritsu Hospital, Tagawa City Hospital, Nagoya Medical Center, Kobe City Medical Center, Urazoe General Hospital, JCHO Kurume General Hospital, Matsuyama Red Cross Hospital, Fukui Saiseikai Hospital, Amakusa Medical Center Hospital. Patients decided whether or not they would participate in the trial after being given a detailed explanation, and written informed consent was obtained from all patients prior to enrolment.
: The informed consent form sated that the result would publish after completed the study. Japanese regulation. The consent of the family is not be demanded at article publication by the ethic guideline in Japan.
: Outside the submitted work, Keisuke Miwa received grants and personal fees from Taiho Pharm., Ono Pharm., Chugai Pharm. and Takeda Pharm., grants from Merck Biopharm. and Pfizer Inc. and Tsumura & Co.; personal fees from Yakult Honsha Co., Ltd., Bristol-Myers Squibb Co. and Novartis Pharma K.K., personal fees from AstraZeneca K.K., Kyowa Kirin Co., Ltd., Nippon Kayaku Co., Ltd. and Eli Lilly.. Outside the submitted work, Eiji Oki received personal fees from Taiho Pharm, Bayer, Chugai Pharm., Takeda Pharm., Ono Pharm., Merck Biopharma., MSD and Yakult Honsha. Outside the submitted work, Goro Nakayama received personal fees from Chugai Pharm., Janssen Pharmaceutical K.K., Yakult Honsha Co. Ltd.. Taiho Pharm., Eli Lilly Japan K.K., Takeda Pharm., and Miyarinsan Pharm.Mototsugu Shimokawa received personal fees from Sysmex outside the submitted work. The other authors have no conflicts of interest to declare.