Pegfilgrastim on-body injector: Post-market performance analysis.

Abstract

e19226 Background: Granulocyte colony-stimulating factors (G-CSF) are widely used in medical oncology for the prevention of neutropenia and its complications. On-body injectors (OBI) have an advantage over the traditional injection (TI) method of not requiring a second visit to the oncology clinic the day after chemotherapy, but these devices are subject to failure. The objective of this study was to assess the efficacy of OBIs in the real world. Methods: Adult women with breast cancer diagnosed between June 2015 and June 2016 treated with cytotoxic chemotherapy and a G-CSF were retrospectively identified from the medical records of Henry Ford Hospital (Detroit, MI, USA). The primary outcome was the incidence of severe neutropenia (SN), defined as an absolute neutrophil count (ANC) ≤500. Secondary outcomes included incidence of neutropenia (ANC ≤1500), neutropenic fever, and mortality. A secondary analysis of the data was performed to identify predictors of SN. Results: A total of 837 cycles of chemotherapy were analyzed. The OBI was used in 395 cycles and the TI in 442. The OBI group had patients that were older, had higher ANC, were more often black, had worse performance status, and were more often smokers. The incidences of SN, neutropenic fever and neutropenia were not different between groups (Table). Mortality was not different between groups when adjusted for confounding variables (OR 1.8, 95% CI 0.9-3.6, p=0.09). Patients with a lower baseline ANC and white ethnicity were at a higher risk for SN. TAC (docetaxel, doxorubicin and cyclophosphamide combined) carried the highest risk for SN among the chemotherapy regimens used. Conclusions: There was no difference in the efficacy of the OBI and TI methods for preventing SN, neutropenic fever, neutropenia, and death. Independent predictors of SN included the chemotherapy regimen used, baseline ANC and ethnicity. [Table: see text]