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However, pegfilgrastim administration requires that patients visit hospital following cancer chemotherapy, thus imposing a burden on patients and those around them. An on\u2010body injector (OBI), which automatically administers pegfilgrastim about 27\u00a0hours 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\u2010controlled 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\u2010mg 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.<\/jats:p>","DOI":"10.1111\/cas.15335","type":"journal-article","created":{"date-parts":[[2022,3,16]],"date-time":"2022-03-16T07:04:08Z","timestamp":1647414248000},"page":"1763-1770","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of a novel medical device for pegfilgrastim administration"],"prefix":"10.1111","volume":"113","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3442-8972","authenticated-orcid":false,"given":"Tomoyuki","family":"Aruga","sequence":"first","affiliation":[{"name":"Department of Breast Surgery Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyoshi","family":"Doihara","sequence":"additional","affiliation":[{"name":"Department of Breast and Endocrine Surgery Okayama University Hospital  Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yasuhiro","family":"Yanagita","sequence":"additional","affiliation":[{"name":"Department of Breast Oncology Gunma Prefectural Cancer Center  Gunma Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takanori","family":"Ishida","sequence":"additional","affiliation":[{"name":"Department of Breast and Endocrine Surgical Oncology Tohoku University Graduate School of Medicine  Sendai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshinari","family":"Yamashita","sequence":"additional","affiliation":[{"name":"Department of Breast and Endocrine Surgery Kanagawa Cancer Center  Yokohama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kanou","family":"Uehara","sequence":"additional","affiliation":[{"name":"Department of Surgery Nahanishi Clinic  Naha Okinawa Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tetsuhiko","family":"Taira","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Sagara Hospital  Kagoshima City Kagoshima Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junji","family":"Tsurutani","sequence":"additional","affiliation":[{"name":"Advanced Cancer Translational Research Institute Showa University  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Takeshita","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery Hokkaido University Hospital  Sapporo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigeru","family":"Tsuyuki","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery Osaka Red Cross Hospital  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Kaneko","sequence":"additional","affiliation":[{"name":"Department of Breast Oncology Niigata Cancer Center Hospital  Niigata Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tohru","family":"Ohtake","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery, School of Medicine Fukushima Medical University  Fukushima Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yusuke","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yui","family":"Hara","sequence":"additional","affiliation":[{"name":"Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shigehira","family":"Saji","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Fukushima Medical University  Fukushima Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,3,29]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.coc.0000217816.16236.22"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyp050"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.3816\/CBC.2002.n.030"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-014-2597-1"},{"key":"e_1_2_8_6_1","unstructured":"G\u2010LASTA\u00aeSubcutaneous Injection 3.6mg Interview Form. 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