D. Dale (Seattle, WA, United States of America)

University of Washington

Author Of 1 Presentation

53P - Incidence of febrile neutropenia (FN), adherence and compliance to granulocyte colony-stimulating factor (G-CSF) on-body injector (OBI) versus other FN prophylaxis in patients receiving myelosuppressive chemotherapy: subgroup analysis in breast cancer patients

Abstract

Background

Pegfilgrastim, a long-acting G-CSF, reduces the risk of chemotherapy-induced FN. Results from the previously reported multicenter, prospective, observational study demonstrated the utility of pegfilgrastim (Neulasta OBI®) in decreasing FN risk and improving adherence and compliance to G-CSF support in cancer patients treated with myelosuppressive chemotherapy. Results of a subgroup analysis in breast cancer patients are reported here.

Methods

Adult patients with breast cancer were stratified into curative or palliative intent groups and further categorized based on the first chemotherapy cycle into subgroups receiving Neulasta OBI® vs other physician choice options. Eligibility criteria for the main analysis included patients with breast, lung, NHL, or prostate cancer with a life expectancy of >6 months, at least 4 planned chemotherapy cycles administered once every 3 or 4 weeks with high (>20%) or intermediate (10%-20%) FN risk and ≥1 risk factor, and no radiation <2 weeks before enrollment. Primary endpoint is the incidence of FN and other endpoints include adherence, compliance and chemotherapy delivery. The subgroup analysis focused on these endpoints in the breast cancer patients exclusively.

Results

A total of 1,776 patients with breast cancer were eligible (OBI, 1,196; Other, 580). Baseline characteristics were generally well balanced across both groups. Across all cycles, incidence of FN was lower in OBI group (4.4%) than in Other group (7.4%). Adherence and compliance to pegfilgrastim was higher in the OBI group (93.8% CI: [92.45%–95.18%] / 90.5% CI: [88.80%–92.13%]) vs Other group (69.8% CI: [66.09%–73.56%] / 53.2% CI: [48.70%–57.80%]).

Conclusions

Breast cancer patients who received Neulasta OBI® showed a lower rate of FN compared with other physician choice options. These results could be achieved due to increased adherence and compliance to G-CSF support in the OBI group compared with other physician choice options.

Editorial acknowledgement

The authors received medical writing and editing support from Advait Joshi, PhD, of Cactus Life Sciences (part of Cactus Communications), which was supported by Amgen Inc.

Legal entity responsible for the study

Amgen Inc.

Funding

Amgen Inc.

Disclosure

R. Mahtani: Advisory/Consultancy: Amgen, Agendia, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, Genentech, Eli Lilly, Novartis, and Puma; Research grant/Funding (self), contracted research: Genentech. G.H. Lyman: Advisory/Consultancy: Agendia, Amgen, Bristol-Myers Squibb, G1 Therapeutics, Genomic Health, Halozyme, Helsinn, Hexal, Partners HealthCare, and Pfizer; Research grant/Funding (self), contracted research: Amgen. R. Rifkin: Advisory/Consultancy: Amgen, Coherus, Mylan, and Pfizer; Research grant/Funding (self), contracted research: Amgen. D. Dale: Advisory/Consultancy: Amgen; Research grant/Funding (self), contracted research: Amgen. A. Brookhart: Advisory/Consultancy: Amgen, Merck, FibroGen, and RxAnte; Research grant/Funding (self), contracted research: Amgen and AbbVie; Shareholder/Stockholder/Stock options, ownership interest: NoviSci. S. Lewis, L. Decosta, T. Lawrence, R. Belani: Shareholder/Stockholder/Stock options, Full/Part-time employment: Amgen. J. Crawford: Advisory/Consultancy: Amgen, AstraZeneca, Coherus, Enzychem, Merck, and Pfizer; Research grant/Funding (self), contracted research: AstraZeneca, Genentech, and Helsinn; Officer/Board of Directors, Chair/DSMB member: BeyondSpring.

Collapse