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. 2022 Jul;30(7):6135-6144.
doi: 10.1007/s00520-022-07025-2. Epub 2022 Apr 14.

A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis

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

A prospective cohort study to evaluate the incidence of febrile neutropenia in patients receiving pegfilgrastim on-body injector versus other options for prophylaxis of febrile neutropenia: breast cancer subgroup analysis

Reshma L Mahtani et al. Support Care Cancer. 2022 Jul.

Abstract

Background: Breast cancer chemotherapy often carries a high risk of febrile neutropenia (FN); guidelines recommend prophylaxis with granulocyte colony-stimulating factor (G-CSF), such as pegfilgrastim. Neulasta® Onpro® on-body injector (OBI) is a delivery device administering pegfilgrastim approximately 27 h after application.

Methods: This prospective study examined patients with breast cancer who received chemotherapy with a high risk of FN, receiving OBI ("OBI") or other options (other G-CSF or none; "other"). The primary endpoint was FN incidence; secondary endpoints included chemotherapy delivery, adherence (G-CSF in all cycles), compliance (G-CSF day after chemotherapy), and FN incidence in patients receiving curative or palliative treatment.

Results: A total of 1776 patients with breast cancer were enrolled (OBI, n = 1196; other, n = 580). Across all cycles, FN incidence was lower for OBI (4.4% [95% CI, 3.3-5.6%]) than other (7.4% [5.3-9.6%]). For curative treatment, the FN incidence across all cycles was lower for OBI (4.6% [3.4-5.8%]) than for other (7.1% [5.0-9.3%]). For palliative treatment (OBI, n = 33; other, n = 20), 3 patients (15%) in the other and none in the OBI group had FN. After adjusting for baseline covariates, FN incidence remained lower for OBI (4.6% [3.5-6.1%]) versus other (7.8% [5.7-10.5%]). Adherence was higher for OBI (93.8%) than for other G-CSF (69.8%), as was compliance (90.5 and 53.2%, respectively). Chemotherapy dose delays/reductions were similar for OBI (4.7%/32.3%, respectively) and other (4.7%/30.0%) groups.

Conclusion: Pegfilgrastim OBI was associated with a lower FN incidence in patients with breast cancer compared to other options for FN prophylaxis.

Trial registration: www.

Clinicaltrials: gov , NCT02178475, registered 30 June, 2014.

Keywords: Breast cancer; Chemotherapy; Compliance; Febrile neutropenia; Pegfilgrastim.

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Conflict of interest statement

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; Rajesh Belani reports employment with Poseida Therapeutics and stock/stock options in Amgen; 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; David Dale reports consulting fees from Amgen, and contracted research support from Amgen; Lucy DeCosta reports employment with Amgen Inc.; Prasad L. Gawade reports employment and stockholding with Amgen Inc.; Chanh Huynh has no disclosures to report; Tatiana Lawrence reports employment and stockholding with Amgen Inc.; Sandra Lewis reports employment and stockholding with Amgen Inc.; William W. MacLaughlin and Mohit Narang have no disclosures to report; Robert Rifkin reports participation in advisory boards for Amgen, BMS (Celgene), Coherus, Fresenius-Kabi, GSK, Janssen, and Pfizer.

Figures

Fig. 1
Fig. 1
Incidence of FN in patients with breast cancer who received pegfilgrastim OBI or other options. a Incidence of FN; percent plus 95% CI. b Incidence of FN in patients who received pegfilgrastim OBI in every cycle; percent plus 95% CI. c Relative risk of FN. CI, confidence interval; FN, febrile neutropenia; OBI, on-body injector; Other, other physician choice options; RR, relative risk
Fig. 2
Fig. 2
Incidence of FN in patients with breast cancer who received pegfilgrastim OBI or other options with curative intent. a Incidence of FN; percent plus 95% CI. b Incidence of FN in patients who received pegfilgrastim OBI in every cycle; percent plus 95% CI. CI, confidence interval; FN, febrile neutropenia; OBI, on-body injector; Other, other physician choice options
Fig. 3
Fig. 3
Incidence of FN in patients with breast cancer who received pegfilgrastim OBI or other options with palliative intent. a Incidence of FN; percent plus 95% CI. b Incidence of FN in patients who received pegfilgrastim OBI in every cycle. The incidence of FN in OBI group was 0% for all cycles. CI, confidence interval; FN, febrile neutropenia; OBI, on-body injector; Other, other physician choice options
Fig. 4
Fig. 4
Adherence to G-CSF and compliance to pegfilgrastim in patients with breast cancer who received pegfilgrastim OBI or other options. a Adherence; percent plus 95% CI. b Compliance; percent plus 95% CI. G-CSF, granulocyte colony-stimulating factor; OBI, on-body injector; Other, other physician choice options
See this image and copyright information in PMC

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