Revisiting same day administration of pegfilgrastim in the age of biosimilars: A review of literature

Abstract

Purpose Since 2018, several pegfilgrastim biosimilars were approved, which may affect insurance reimbursement. Guidelines recommend pegfilgrastim be administered the days following chemotherapy to prevent hematopoietic toxicity. To date, only the reference pegfilgrastim product has an available autoinjector-device. This has contributed to logistical issues in administering biosimilar agents per guideline recommendations. Administration on the same day as chemotherapy may be a potential alternative when logistical issues are present. This review will assess current evidence on this practice to inform clinical decisions. Data sources: A comprehensive literature search was performed in PubMed/Medline for studies examining the administration of pegfilgrastim on the same day as chemotherapy. Data summary: Several studies were identified, including a systematic review, retrospective reviews, and insurance claim data. Studies had significant limitations, and chemotherapy regimens and cancer types varied among studies. Studies showed inconsistent results in terms of incidence, duration, and severity of febrile neutropenia. In studies with patients with head and neck, urothelial, gynecologic, gastrointestinal, and prostate cancer, no difference in outcomes was detected or outcomes supported the feasibility of same-day administration. In patients with breast cancer, outcomes were worse with same-day administration. Outcomes were mixed in studies with non-Hodgkin’s lymphoma, non-small cell lung cancer, and various solid tumors. Conclusion Administration of pegfilgrastim on the same day as chemotherapy may be safe and an acceptable alternative, if logistics prohibit a patient from receiving administration the days after chemotherapy. Clinicians should consider patient risk factors and prescribed chemotherapy regimens, along with available evidence when contemplating administration of same-day pegfilgrastim.

A prospective study to evaluate febrile neutropenia incidence in patients receiving pegfilgrastim on-body injector vs other choices

“…Although pegfilgrastim should not be administered until the day after chemotherapy according to the FDA-approved regimen, there has been an ongoing interest in evaluating administration on the same day as chemotherapy [ 29 , 30 ]. Logistic concerns (e.g., scheduling and travel) and convenience continue to evoke interest in same-day administration.…”

Same-Day Versus Next-Day Pegfilgrastim or Pegfilgrastim-Cbqv in Patients with Lymphoma Receiving CHOP-Like Chemotherapy

“…Due to the reportedly increased risk of myelosuppression and FN with same-day filgrastim (unpegylated, short-acting G-CSF) [21], several studies have investigated possible differences in FN prophylaxis and associated outcomes (grade 3/4 CIN, hospitalizations) between next-day administration and the common real-world practice of same-day administration of pegfilgrastim, the pegylated, long-acting form of G-CSF [24,29,30,33]. A recent review suggested that efficacy of same-day pegfilgrastim may be dependent on the chemotherapy regimen administered [20], and a growing body of data shows that same-day pegfilgrastim can be considered for the neutropenia prophylaxis, as acknowledged in the latest NCCN guidelines [1].…”

“…The review article used as a reference in the NCCN guidelines summarized the available data qualitatively rather than quantitatively and concluded the benefit of next-day administration despite five of 11 included publications showing lower or comparable rates and duration of neutropenia and/or FN with same-day administration [37]. In contrast, a more recent review acknowledges mixed outcomes with same-day administration (dependent on tumor type and chemotherapy regimen) and suggests that same-day administration was possible based on case-by-case consideration of patient risk factors and chemotherapy regimen [20].…”

“…However, failure rates ranging from 1.7 to 6.9% have been reported with this device [17][18][19]. Although not on label, a third option is the administration of pegfilgrastim on the same day as chemotherapy (i.e., within 24 h), which would eliminate a second outpatient visit, and may therefore benefit patients, their caretakers, and healthcare providers [20].…”

Pegfilgrastim Biosimilars in US Supportive Oncology: A Narrative Review of Administration Options and Economic Considerations to Maximize Patient Benefit

“…In the most recent iteration (v1.2022), the National Comprehensive Cancer Network (NCCN) hematopoietic growth factor guidelines recommend next-day administration of pegfilgrastim (i.e., US Food and Drug Administration [FDA]–recommended dosing); however, in acknowledgment of the growing body of evidence, the guidelines indicate that same-day administration may be used [ 4 ]. Any use of same-day administration must be weighed against the potential for increased risk of febrile neutropenia [ 16 ]. Because of the COVID-19 pandemic, the option of same-day administration is especially pertinent to minimize additional clinic visits and risks of SARS-CoV-2 exposure.…”