Usefulness of an S-1 dosage formula: an exploratory analysis of randomized clinical trial (JCOG1001).

"Declarations Conflict of interestTakeshi Kawakami received honoraria from Taiho Pharmaceutical, Ono Pharmaceutical, and Bristol-Myers Squibb. Junki Mizusawa received National Cancer Center Research and Development Funds and Japan Agency for Medical Research and Development via his institution and honoraria from Taiho Pharmaceutical and Chugai Pharmaceutical. Satoru Iwasa received research funding from Taiho Pharmaceutical via his institution and honoraria from Taiho Pharmaceutical. Narikazu Boku received grants from Ono Pharmaceutical and Takeda Pharmaceutical, honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Taiho Pharmaceutical, and Daiichi-Sankyo. Yuichiro Doki received honoraria from Taiho Pharmaceutical. Takaki Yoshikawa received lecture fee from Taiho Pharmaceutical. Yukinori Kurokawa received lecture fee from Taiho Pharmaceutical. Masanori Terashima received honoraria from Taiho Pharmaceutical, Chugai Pharmaceutical, Eli Lilly Japan, Ono Pharmaceutical, Bristol-Myers Squibb Japan, Yakult Honsha, Takeda Pharmaceutical, Pfizer Japan, Astra-Zeneca, Daiichi-Sankyo, Johnson and Johnson, Medtronic Japan, Intuitive Japan, and Olympus. The other authors declare that they have no conflict of interest. Ethical standardsAll procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent to be included in the study, or the equivalent, was obtained from all patients. Conflict of interest Takeshi Kawakami received honoraria from Taiho Pharmaceutical, Ono Pharmaceutical, and Bristol-Myers Squibb. Junki Mizusawa received National Cancer Center Research and Development Funds and Japan Agency for Medical Research and Development via his institution and honoraria from Taiho Pharmaceutical and Chugai Pharmaceutical. Satoru Iwasa received research funding from Taiho Pharmaceutical via his institution and honoraria from Taiho Pharmaceutical. Narikazu Boku received grants from Ono Pharmaceutical and Takeda Pharmaceutical, honoraria from Ono Pharmaceutical, Bristol-Myers Squibb, Taiho Pharmaceutical, and Daiichi-Sankyo. Yuichiro Doki received honoraria from Taiho Pharmaceutical. Takaki Yoshikawa received lecture fee from Taiho Pharmaceutical. Yukinori Kurokawa received lecture fee from Taiho Pharmaceutical. Masanori Terashima received honoraria from Taiho Pharmaceutical, Chugai Pharmaceutical, Eli Lilly Japan, Ono Pharmaceutical, Bristol-Myers Squibb Japan, Yakult Honsha, Takeda Pharmaceutical, Pfizer Japan, Astra-Zeneca, Daiichi-Sankyo, Johnson and Johnson, Medtronic Japan, Intuitive Japan, and Olympus. The other authors declare that they have no conflict of interest."

"Funding The study was supported in part by the National Cancer Center Research and Development Funds (20S-3, 23-A-16, 23-A-19, 26-A-4, 29-A-3, 2020-J-3) and by AMED under Grant Number (JP16ck0106048)."

"The details of the JCOG1001 trial, registered in UMIN–CTR (UMIN000003688), were previously reported []. The main inclusion criteria were histologically proven resectable gastric adenocarcinoma with an estimated cT3 (SS) or cT4 (SE). Patients were randomized into the non-bursectomy arm or bursectomy arm. After R0 resection, the patients received postoperative adjuvant chemotherapy with S-1 as a protocol treatment except for pT1. The severity of adverse events was evaluated by the National Cancer Institute–Common Terminology Criteria for Adverse Events (NCI–CTCAE) version 4.0."