ワカバヤシ ムネヒロ   Wakabayashi Munehiro
  若林 宗弘
   所属   東邦大学  医学部 医学科(大森病院)
   職種   助教
論文種別 原著
言語種別 英語
査読の有無 査読あり
表題 Safety of a short-term infusion of fosnetupitant in patients with gastrointestinal and breast cancer: a prospective study
掲載誌名 正式名:The oncologist
略  称:Oncologist
ISSNコード:10837159
掲載区分国外
巻・号・頁 oyae223
著者・共著者 Akinobu Nakata, Naoya Hashimoto, Yukiya Narita, Munehiro Wakabayashi, Hiroyuki Kodama, Takatsugu Ogata, Kazunori Honda, Toshiki Masuishi, Hiroya Taniguchi, Shigenori Kadowaki, Masashi Ando, Yuka Endo, Haruru Kotani, Ayumi Kataoka, Masaya Hattori, Akiyo Yoshimura, Masataka Sawaki, Kazuki Nozawa, Isao Oze, Hiroji Iwata, Kei Muro
発行年月 2024/09/11
概要 Background: Fosnetupitant, a neurokinin-1 receptor antagonist, is used to prevent chemotherapy-induced nausea and vomiting (CINV) in patients undergoing highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).
Methods: This was a single-arm, phase II study to investigate the safety of a 15-minute infusion of fosnetupitant in patients with gastrointestinal and breast cancer. Patients who had received their dose of fosnetupitant in a 30-minute infusion without developing an allergic reaction were eligible and received their next fosnetupitant dose for 15 minutes. The primary endpoint was the incidence of an allergic reaction during the first 15-minutes infusion.
Results: The study period was from February 17, 2023 to June 20, 2023. In an exploratory analysis, medical records from the end of the study period to December 31, 2023 were retrospectively evaluated. Fifty-six patients with gastrointestinal and 14 patients with breast cancer were enrolled, one of whom with breast cancer did not receive study treatment at her own request. No allergic reactions occurred during the 15-minutes infusion. Furthermore, there were no allergic reactions across all 280 short-term injections.
Conclusion: Short-term infusion of fosnetupitant, administered over 15 minutes, was demonstrated to be safe and effective for patients receiving HEC or MEC (Japan Registry of Clinical Trials Trial ID: jRCT1041220144).