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Observational Study
. 2022 Oct;30(10):7913-7922.
doi: 10.1007/s00520-022-07226-9. Epub 2022 Jun 22.

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

Robert M Rifkin  1 , Jeffrey Crawford  2 , Reshma L Mahtani  3 , David C Dale  4 , Mohit Narang  5 , William W MacLaughlin  6 , Chanh Huynh  7 , Prasad L Gawade  8 , Sandra Lewis  8 , Lucy DeCosta  9 , Tatiana Lawrence  8 , Rajesh Belani  8
Affiliations
Observational Study

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

Robert M Rifkin et al. Support Care Cancer. 2022 Oct.

Abstract

Purpose: We evaluated the incidence of febrile neutropenia (FN) and related clinical outcomes among patients treated with myelosuppressive chemotherapy for nonmyeloid malignancies who received pegfilgrastim on-body injector (OBI) or other options (Other) for FN prophylaxis.

Methods: In this prospective observational study, adult patients with breast, prostate, or lung cancer, or non-Hodgkin lymphoma at risk for FN were stratified into subgroups based on FN prophylaxis used in the first chemotherapy cycle: pegfilgrastim OBI vs Other (pegfilgrastim or biosimilar pegfilgrastim prefilled syringe, daily filgrastim, or no granulocyte colony-stimulating factor [G-CSF]) for up to 4 planned chemotherapy cycles.

Results: This US study enrolled 2575 eligible patients (OBI, 1624; Other, 951). FN incidence was lower in the OBI group (6.4% [95% CI, 5.2-7.6%]) than in the Other group (9.4% [7.5-11.2%]), with a relative risk (RR) of 0.66 (0.47-0.91; p = .006). A decreased risk of dose delays among patients receiving pegfilgrastim OBI vs Other was observed (RR for ≥ 5 days: 0.64 [0.42-0.96], p = .023; RR for ≥ 7 days: 0.62 [0.40-0.91], p = .016). Adherence, defined as G-CSF support for all chemotherapy cycles, was 94.0% (92.9-95.2%) in the OBI group compared with 58.4% (55.2-61.5%) in the Other group. Compliance with pegfilgrastim, defined as administration the day after chemotherapy, was 88.3% in the OBI group and 48.8% in the prefilled syringe group.

Conclusion: Patients receiving pegfilgrastim OBI had a lower incidence of FN compared with those receiving alternatives. The OBI was associated with improved adherence to and compliance with clinically recommended G-CSF prophylaxis.

Keywords: Febrile neutropenia; On-body injector (OBI); Pegfilgrastim.

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Conflict of interest statement

Robert M. Rifkin reports participation in advisory boards for Amgen, BMS (Celgene), Coherus, Fresenius-Kabi, GSK, Janssen, and Pfizer. Jeffrey Crawford reports consulting fees from GlaxoSmithKline, G1 Therapeutics, Merck, Pfizer, Spectrum, and participation on a data safety monitoring board or advisory board for Beyond Spring, G1 Therapeutics, Merrimack, Mylan, and Roche. Reshma L. Mahtani reports consulting fees from Biotheranostics, Amgen, Agendia, Eisai, Immunomedics, Genentech, Lilly, Novartis, Merck, Pfizer, Puma, Sanofi, Seagen, AstraZeneca, Daiichi, and participation on an advisory board for AstraZeneca, Amgen, Agendia, Biotheranostics, Eisai, Immunomedics, Lilly, Novartis, Merck, Pfizer, Puma, Sanofi, Seagen, and Daiichi. David Dale reports consulting fees from Amgen, and contracted research support from Amgen. Sandra Lewis, Lucy DeCosta, and Tatiana Lawrence are employees and stockholders of Amgen. Prasad L. Gawade and Rajesh Belani were employees of Amgen; Rajesh Belani is an employee and a stockholder of Poseida Therapeutics. Mohit Narang, William W. MacLaughlin, and Chanh Huynh have no disclosures to report.

Figures

Fig. 1
Fig. 1
Incidence of febrile neutropenia. (a) FN incidence in patients receiving pegfilgrastim OBI vs other physician choice options. (b) FN incidence in patients receiving pegfilgrastim OBI in every cycle vs other physician choice options. (c) Relative risk of FN. Error bars denote 95% CIs. CI, confidence interval; FN, febrile neutropenia; OBI, on-body injector; Other, other physician choice options; RR, relative risk
Fig. 2
Fig. 2
Relative risks of chemotherapy dose delays (≥ 5 and ≥ 7 days)/reductions (≥ 15%) in patients receiving pegfilgrastim OBI, and those receiving pegfilgrastim OBI in every cycle vs other physician choice options. Error bars denote 95% CIs. CI, confidence interval; OBI, on-body injector; RR, relative risk
Fig. 3
Fig. 3
Adherence to G-CSF and compliance with pegfilgrastim. (a) Adherence and (b) Compliance in patients receiving pegfilgrastim OBI and in patients receiving pegfilgrastim OBI in every cycle. Error bars denote 95% CIs. CI, confidence interval; G-CSF, granulocyte colony–stimulating factor; OBI, on-body injector; Other, other physician choice options
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References

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