BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated With High–Neutropenia Risk Chemotherapy
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Background: Chemotherapy-induced febrile neutropenia (FN) is prevented or minimized with granulocyte colony-stimulating factors (G-CSFs). Several G-CSF biosimilars are approved in the United States. The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is a nonprofit initiative whose objective is to provide scientific evidence on real-world use and comparative safety and effectiveness of biologics and biosimilars using the BBCIC distributed research network (DRN). Patients and Methods: We describe real-world G-CSF use in patients with breast or lung cancer receiving first-cycle chemotherapy associated with high FN risk. We assessed hospitalizations for FN, availability of absolute neutrophil counts, and G-CSF–induced adverse events to inform future observational comparative effectiveness studies of G-CSF reference products and their biosimilars. A descriptive analysis of 5 participating national health insurance plans was conducted within the BBCIC DRN. Results: A total of 57,725 patients who received at least one G-CSF dose were included. Most (92.5%) patients received pegfilgrastim. FN hospitalization rates were evaluated by narrow (<0.5%), intermediate (1.91%), and broad (2.99%) definitions. Anaphylaxis and hyperleukocytosis were identified in 1.15% and 2.28% of patients, respectively. This analysis provides real-world evidence extracted from a large, readily available database of diverse patients, characterizing G-CSF reference product use to inform the feasibility of future observational comparative safety and effectiveness analyses of G-CSF biosimilars. We showed that the rates of FN and adverse events in our research network are consistent with those reported by previous small studies. Conclusions: Readily available BBCIC DRN data can be used to assess G-CSF use with the incidence of FN hospitalizations. Insufficient laboratory result data were available to report absolute neutrophil counts; however, other safety data are available for assessment that provide valuable baseline data regarding the effectiveness and safety of G-CSFs in preparation for comparative effectiveness studies of reference G-CSFs and their biosimilars.
Submitted May 21, 2020; final revision received February 15, 2021; accepted for publication February 16, 2021.
Published online August 16, 2021.
Author contributions: Study concept and design: Pawloski, Marshall, Pindolia, Panozzo, Brown, Eichelberger. Provision of study materials: Marshall, Brown. Acquisition and assembly of data: Marshall, Brown. Data analysis and interpretation: All authors. Manuscript preparation and final approval: All authors.
Disclosures: Dr. Pawloski has disclosed serving as a scientific partner of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) and receiving financial support for the conduct of the work described in this article. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: Support for this work was provided by the BBCIC members.
Data availability statement: The primary data are under the full control of Harvard Pilgrim Health Care Institute, and we agree to allow the journal to review the data, if requested.
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