@article{dae6d7037dfa4cdda17085b9b5370192,
title = "Feasibility study of nivolumab as neoadjuvant chemotherapy for locally esophageal carcinoma: FRONTiER (JCOG1804E)",
abstract = "One of the standard treatments of resectable esophageal squamous cell carcinoma (ESCC) is neoadjuvant chemotherapy followed by surgery. Nivolumab showed efficacy for metastatic ESCC. However, the safety and efficacy of neoadjuvant nivolumab with chemotherapy for ESCC is unknown. Therefore, we will conduct FRONTiER to evaluate the safety and efficacy of nivolumab adding to neoadjuvant chemotherapy. FRONTiER comprises four experimental cohorts: (A) including nivolumab plus 5-FU+CDDP (cisplatin and 5-fluorouracil [CF]); (B) including one prior administration of nivolumab and the cohort A regimen; (C) including nivolumab plus docetaxel+ CF; (D) including one prior administration of nivolumab and the cohort C regimen; an expanded cohort. The primary end point is the incidence of dose-limiting toxicities from the initial dose to the 30th postoperative day. Clinical Trial Identifier: NCT0391444. ",
keywords = "5-fluorouracil, cisplatin, docetaxel, esophageal squamous cell carcinoma, immune checkpoint inhibitor, neoadjuvant chemotherapy, nivolumab",
author = "Shun Yamamoto and Ken Kato and Hiroyuki Daiko and Takashi Kojima and Hiroki Hara and Tetsuya Abe and Yasuhiro Tsubosa and Kengo Nagashima and Kazunori Aoki and Yukihiro Mizoguchi and Shigehisa Kitano and Shinichi Yachida and Satoshi Shiba and Yuko Kitagawa",
note = "Funding Information: S Yamamoto and H Daiko, T Abe, Y Tsubosa, K Nagashima, Y Mizoguchi, S Yachida, S Shiba have nothing to declare. K Kato has received research funds from ONO Pharmaceuticals and MSD, AstraZeneca, BeiGene, personal fees from Lilly. T Kojima has received grants from Ono Pharmaceuticals and MSD, Oncolys BioPharma, Astellas, Amgen BioPharma, Chugai, Parexel, Shionogi. Funding Information: This study was funded by ONO Pharmaceuticals. Funding Information: H Hara has received grants from Japan Agency for Medical Research and Development (AMED) and AstraZeneca, Daiichi Sankyo, Dainippon Sumitomo Pharma, Merck Serono, Merck Sharp & Dohme, Taiho, Chugai, Eisai, LSK BioPharma, Incyte, Pfizer, Boehringer Ingelheim, BeiGene, Ono Pharmaceuticals, BMS and personal fees from Daiichi Sankyo and Lilly, Merck Sharp & Dohme, Taiho, Chugai, Ono Pharmaceuticals, Bristol-Myers Squibb, Yakult Honsha, Sanofi, Takeda Pharmaceutical. K Aoki has received grants from Ono Pharmaceuticals, Otsuka Pharmaceutical, Eisai. S Kitano has received grants from Boehringer Ingelheim, Eisai, Astellas, Gilead Sciences, Regeneron, AMED, Japan Society for the Promotion of Science and personal fees from AstraZeneca, Chugai, Pfizer, Sanofi, Nippon Kayaku, Boehringer Ingelheim, Meiji Seika Pharma, Taiho, Novartis, Daiichi Sankyo, Merck Sharp & Dohme, Kyowa Hakko Kirin, Celgene, Sumitomo Dainippon Pharma, Eisai, Ono Pharmaceuticals, Bristol-Myers Squibb, Regeneron, AYUMI Pharmaceutical Corporation, Rakuten Medical, Pharmaceuticals and Medical Devices Agency, GlaxoSmithKline. Y Kitagawa has received grants from Taiho and Chugai, Yakult Honsha, Daiichi Sankyo, Merck Serono, Asahi Kasei, EA Pharma, Otsuka Pharmaceutical, Takeda Pharmaceutical, Otsuka Pharmaceutical Factory, Shionogi, KAKEN PHARMACEUTICAL, Kowa Pharmaceutical, Astellas Pharma, Medicon, Sumitomo Dainippon Pharma, Taisho Toyama Pharmaceutical, Kyouwa Hakkou Kirin, Pfizer Japan, Ono Pharmaceuticals, Nihon Pharmaceutical, Japan Blood Products Organization, Medtronic Japan, Sanofi, Eisai, TSUMURA, KCI Licensing, Abbott Japan, FUJIFILM Toyama Chemical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. Publisher Copyright: {\textcopyright} 2020 ",
year = "2020",
month = jul,
doi = "10.2217/fon-2020-0189",
language = "English",
volume = "16",
pages = "1351--1357",
journal = "Future Oncology",
issn = "1479-6694",
publisher = "Future Medicine Ltd.",
number = "19",
}
