Abstract 1884P
Background
The effectiveness of granulocyte colony-stimulating factors like pegfilgrastim (Neulasta®) depends on the optimal timing (recommended ≥24 h after chemotherapy (CTx)). The On-body injector (OBI) is a device designed to automatically deliver pegfilgrastim 27 h after CTx without need of return visit to the medical office. The CONVENIENCE study evaluated patient, nurse and physician preferences for pegfilgrastim administration via OBI vs. pre-filled syringe (PS) in Germany.
Methods
In this randomized, multicenter, cross-over, investigator sponsored study (partially funded by AMGEN GmbH) early breast cancer (EBC) patients (pts) received anthracycline/cyclophosphamide Q2W / Q3W or taxane-based CTx Q3W and Non-Hodgkin lymphoma (NHL) pts received 1st-line R-CHOP-14 or -21. Pts were observed for 4 CTx cycles supported with pegfilgrastim OBI or PS in an alternating sequence with 1:1 randomization of the application form to start with. Preferences were evaluated using questionnaires.
Results
From 06/2018 to 06/2019, 308 randomized pts in 41 sites in Germany were evaluated in the per-protocol analysis. The median age was 56 years, 91.2% of pts had EBC and 8.8% had NHL. ECOG performance status was 0 or 1 for all pts. Pegfilgrastim was administered 24 to <72 h after CTx in 97.6% of OBI and 63.1% of PS applications. Preferences were as follows: Table: 1884P
| Preference after study* (%) | ||||
| OBI | PS | No preference | Missing | |
| All Pts (100%) | 43.2 | 36.0 | 20.8 | - |
| Pts with all PS administrations at - private environment (58.1%) - oncological practice (22.1%) - mixed locations (11.0%) - general practitioner (4.9%) | 44.1 44.1 41.2 33.3 | 38.5 30.9 32.4 40.0 | 17.3 25.0 26.5 26.7 | - - - - |
| Nurse | 43.9 | 46.3 | - | 9.8 |
| Physician | 36.6 | 58.5 | - | 4.9 |
*Preferences were very similar in both study arms and are not shown separately.
Conclusions
After study OBI was slightly preferred by pts. Only pts who received the PS at a general practitioner rather preferred the PS. The PS was physicians’ most preferable choice and slightly preferred by nurses. However, the present data show that in routine the PS is often not administered in the recommended time period, whereas at least in this study OBI was almost always applied as specified.
Clinical trial identification
NCT03619993.
Editorial acknowledgement
Legal entity responsible for the study
iOMEDICO AG, Freiburg, Germany.
Funding
AMGEN GmbH.
Disclosure
M. Metz: Officer/Board of Directors: NIO Niedersachsen; Advisory/Consultancy, Shareholder/Stockholder/Stock options: Novartis; Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Celgene; Honoraria (self): Octapharm; Honoraria (self): Abbvie; Boehringer Ingelheim; Amgen; Hexal. C. Hielscher: Honoraria (self): Amgen; Pfizer; Roche; Honoraria (self), Travel/Accommodation/Expenses: Celgene; Travel/Accommodation/Expenses: Oncovis. M-O. Zahn: Leadership role: MVZ Onkologische Kooperation Harz; Officer/Board of Directors: NIO Niedersachsen e.V. All other authors have declared no conflicts of interest.