ドイハラ　ヒロヨシ   Hiroyoshi Doihara   土井原　博義    所属   川崎医科大学  医学部 臨床医学　総合外科学    職種   特任教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	Evaluation of a novel medical device for pegfilgrastim administration.
掲載誌名	正式名：Cancer science 略　 称：Cancer Sci ISSNコード：13497006/13479032
掲載区分	国外
巻・号・頁	pp.1
著者・共著者	Aruga Tomoyuki, Doihara Hiroyoshi, Yanagita Yasuhiro, Ishida Takanori, Yamashita Toshinari, Uehara Kanou, Taira Tetsuhiko, Tsurutani Junji, Takeshita Takashi, Tsuyuki Shigeru, Kaneko Koji, Ohtake Tohru, Yamaguchi Yusuke, Hara Yui, Saji Shigehira
発行年月	2022/03
概要	Pegfilgrastim, a pegylated form of granulocyte colony-stimulating factor, has reduced the risk of developing febrile neutropenia, which is associated with an increase in severe infection and prolonged hospitalization. However, pegfilgrastim administration requires that patients visit hospital following cancer chemotherapy, thus imposing a burden on patients and those around them. An on-body injector (OBI), which automatically administers pegfilgrastim about 27 hours after chemotherapy, was used in this study. The OBI, which consists of a main pump unit and infusion set, is a drug delivery device designed to be attached to the patient's body, with a timer-controlled dosing function. This study was conducted in breast cancer patients to evaluate the safety of pegfilgrastim administered subcutaneously via the OBI. The study period consisted of screening and treatment observation periods involving four cycles of neoadjuvant or adjuvant chemotherapy with docetaxel plus cyclophosphamide. One 3.6-mg pegfilgrastim dose was administered subcutaneously via OBI during each cycle of chemotherapy. The study enrolled 35 patients, and no serious adverse events or febrile neutropenia occurred. Administration of pegfilgrastim was successfully completed at all times when the OBI was attached to the patient, and no safety concerns associated with OBI function arose. For outpatients requiring pegfilgrastim following cancer chemotherapy, the use of an OBI was considered to be a safe option to reduce the need for outpatient visits that restrict their activities of daily living.
DOI	10.1111/cas.15335
PMID	35293085