Pegfilgrastim Use and Outcomes In Non-Hodgkin-Lymphoma Patients Receiving Chemotherapy In Clinical Practice: Combined Analysis Of The Austrian and Swiss E-Avare Studies
Authors: Willenbacher Wolfgang , Haslbauer Ferdinand , Neumeister Peter , Guttmann Anton , Sperb Roland , Lohri Andreas , Saldutto Biagio , Jaeger Christine , Bast Carine , Renner Christoph 
Published: October 2019

Abstract

Background
E-AVARE were observational studies in Austria and Switzerland investigating febrile neutropenia (FN) risk assessment and granulocyte colony-stimulating factor (G-CSF) guideline implementation in real life Non-Hodgkin-lymphoma (NHL) treatment. A combined analysis of both studies was performed to better understand the characteristics of NHL patients who receive pegfilgrastim and the outcomes of these patients in everyday clinical practice.

Methods
Eligible patients had NHL, were eligible to receive G-CSF, and were planned to receive ≥3 chemotherapy (CT) cycles. The Austrian study included pegfilgrastim treated patients only, while the Swiss study included all G-CSF formulations used. To evaluate pegfilgrastim-related outcomes, only data from patients who completed ≥3 CT cycles and who received pegfilgrastim in ≥1 cycle were included (primary analysis set). Primary outcome: proportion of patients with investigator-assessed high (≥20%) overall FN risk in cycle 1 receiving pegfilgrastim as primary prophylaxis (PP). Other outcomes: investigator-assessed CT-related FN risk, overall incidence of FN and unplanned hospitalizations. Exploratory analysis: description of age cohorts (<65 or ≥65 years [yrs]).

Results
277 patients fulfilled the inclusion criteria for the primary analysis set. Table 1 shows patient characteristics and outcomes. In cycle 1, 237 patients had an investigator-assessed ≥20% overall FN risk and of these 219 (92%) received pegfilgrastim as PP. Among all 277 patients, pegfilgrastim was administered as PP in 236 (85%); pegfilgrastim was first administered in the second or later cycle in 41 patients, of these 8 (3%) received daily G-CSF and 33 (12%) received no G-CSF in cycle 1. Older patients were less likely to receive chemotherapy with curative intent or with high FN risk; FN incidence was similar between age groups but older patients had a greater duration of hospitalization for FN. No serious adverse drug reactions were reported.

Conclusions
In patients with NHL pegfilgrastim was used predominantly as PP in patients assessed at an overall high risk of FN, in accordance with guidelines. Older patients who received CT with intermediate FN risk were more likely than younger patients to be assessed as high overall FN risk. FN risk seemed well managed with pegfilgrastim use in both older and younger patients, but FN may carry a greater burden in patients aged ≥65 yrs, although less intensive therapies were used in this subset of patients.
Medical Writer: Margit Hemetsberger (Amgen-sponsored)

Disclosures:
Willenbacher: Amgen: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Jaeger:Amgen: Employment, Equity Ownership. Bast:Amgen: Employment, Equity Ownership. Renner:Amgen: Consultancy, Honoraria, Speakers Bureau.