BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated With High-Neutropenia Risk...

Area of Science:

• Oncology
• Pharmacology

Background:

• Granulocyte colony-stimulating factors (G-CSFs) are crucial for preventing chemotherapy-induced febrile neutropenia (FN).
• Several G-CSF biosimilars are approved in the US, necessitating real-world evidence on their use.
• The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) aims to provide such evidence via its Distributed Research Network (DRN).

Purpose of the Study:

• To describe real-world G-CSF utilization in cancer patients at high risk of FN.
• To assess hospitalizations for FN and G-CSF-related adverse events.
• To inform the design of future comparative effectiveness studies of G-CSF reference products and biosimilars.

Main Methods:

• A descriptive analysis of 57,725 patients receiving at least one G-CSF dose was conducted.
• Data were sourced from the BBCIC DRN, encompassing 5 national health insurance plans.
• Hospitalizations for FN and adverse events like anaphylaxis and hyperleukocytosis were evaluated.

Main Results:

• Most patients (92.5%) received pegfilgrastim, a type of G-CSF.
• FN hospitalization rates varied based on definition (narrow <0.5%, intermediate 1.91%, broad 2.99%).
• Anaphylaxis and hyperleukocytosis occurred in 1.15% and 2.28% of patients, respectively, consistent with prior studies.

Conclusions:

• BBCIC DRN data effectively support assessment of G-CSF use and FN hospitalization incidence.
• While absolute neutrophil count data were limited, other safety data provide valuable baseline information.
• This real-world evidence is essential for upcoming comparative effectiveness studies of G-CSF biosimilars.