(110) Evaluation of Same-Day vs Next Day Administration of Prophylactic Pegfilgrastim in Fluoropyrimidine-Based GI Cancer Treatment

Poster Abstract:

Background: Although the treatment of most gastrointestinal (GI) cancers has evolved tremendously in the last decade, the complications from treatment have persisted. Despite the increase in prevalence of immunotherapy, the standard of care in the treatment of many GI cancers remains to be fluoropyrimidine-based regimens. These regimens, while effective, carry a noteworthy risk for development of neutropenia, brought on by bone marrow suppression. Pegfilgrastim is a granulocyte-colony stimulating factor (GCSF) used to prevent chemotherapy-induced neutropenia. Historically, all GCSFs including pegfilgrastim are administered 24 hours following the administration of the last chemotherapeutic agent. This directive arises from the belief that circulating cytotoxic chemotherapy would interfere with GCSF stimulated white blood cell production and create a paradoxical worsening of neutropenia. Despite the widely practiced policy of delayed GCSF administration by 24 hours from chemotherapy, there is little literature to support the necessity of a practice in the setting of GI cancers. The mechanism of the aforementioned toxicity is theoretical and has never been fully supported or identified in literature nor in clinical trials.

Purpose: The primary purpose of this study is to compare same-day administration of pegfilgrastim based GCSF to next day administration in terms of safety, efficacy, and cost to institution. Pegfilgrastim biosimilar pegfilgrastim-cbqv (UDENYCA©) and pegfilgrastim on-body applicator (NEULASTA ON-PRO©) are the two most commonly used GCSFs used for the prevention of chemotherapy-induced neutropenia at all NCI facilities and will be the focus of this study.

Methods: A multicenter, retrospective chart review of patients who received pegfilgrastim-based GCSF for an associated GI cancer treated with FOLFOX, FOLFIRI, FLOT, or FOLFIRINOX chemotherapy from December 11, 2021 to December 11, 2023 at NCI. The primary outcome for the study is the development of febrile neutropenia while receiving GCSF; secondary outcomes are grade 3-4 neutropenia and institutional cost for each GCSF modality. The exclusion criteria were patients < 18 years old, pregnant women, patients enrolled in clinical trials during GCSF administration, and patients who did not receive either pegfilgrastim-cbqv or NEULASTA ON-PRO© as their form of GCSF.

Results: Results pending

Conclusions: Pending results

References (must also be included in final poster): 1. Eckstrom J, Bartels T, Abraham I, et al. A single-arm, retrospective analysis of the incidence of febrile neutropenia using same-day versus next-day pegfilgrastim in patients with gastrointestinal cancers treated with FOLFOX or FOLFIRI. Supportive Care in Cancer. 2018;27(3):873-878. doi:https://doi.org/10.1007/s00520-018-4373-0
2. Matera R, Relias V, Muhammad Wasif Saif. Safety and Efficacy of Same-Day Administration of Pegfilgrastim in Patients Receiving Chemotherapy for Gastrointestinal Malignancies. 2020;4(1):6-11.
3. Basel Shoua, Mahta Mahmoudieh, Scott AJ, Hollings J, Shroff RT, McBride A. Evaluation of febrile neutropenia and myelosuppression in patients receiving FOLFOX/FOLFIRI in gastrointestinal cancer treated with same-day (SD) pegfilgrastim/pegfilgrastim-CBQV (PFG). Journal of Clinical Oncology. 2021;39(28_suppl):311-311. doi:https://doi.org/10.1200/jco.2020.39.28_suppl.311