Evaluation of a novel medical device for pegfilgrastim administration

Tomoyuki Aruga, Hiroyoshi Doihara, Yasuhiro Yanagita, Takanori Ishida, Toshinari Yamashita, Kanou Uehara, Tetsuhiko Taira, Junji Tsurutani, Takashi Takeshita, Shigeru Tsuyuki, Koji Kaneko, Tohru Ohtake, Yusuke Yamaguchi, Yui Hara, Shigehira Saji

Research output: Contribution to journalArticlepeer-review

Abstract

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.

Original languageEnglish
JournalCancer Science
DOIs
Publication statusAccepted/In press - 2022
Externally publishedYes

Keywords

  • breast cancer
  • chemotherapy
  • febrile neutropenia
  • medical device
  • pegfilgrastim

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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