Pooled-analysis of Lipegfilgrastim Effectiveness and Safety Among Patients With Blood Malignancies in the Real-world Setting.

BACKGROUND/AIM:The aim of this report was to summarize the real-world experience with lipegfilgrastim as a neutropenia prophylaxis in a large cohort of lymphoma patients receiving immuno-, chemo-therapy. PATIENTS AND METHODS:Observational clinical data were derived from two phase IV studies (NADIR and LEOS) with similar protocols conducted in eight European countries for 677 patients. RESULTS:Categories for risk of febrile neutropenia were predominantly high (54.5%) or intermediate (38.8%). The most frequent patient-associated risk factors were age >65 years (54.4%), female sex (43.9%), hemoglobin <12 g/dL (25.3%), and prior febrile neutropenia (14.5%). The incidence of febrile neutropenia and Grade 3/4 neutropenia was 5.9% and 14.6%, respectively over all cycles of immuno-, chemo-therapy (n=3018). Adverse drug reactions occurred in 74 patients (10.9%), with bone pain (2.2%), myalgia (1.8%), and pyrexia (1.0%) occurring in ≥1% of patients. CONCLUSION:Lipegfilgrastim prophylaxis against chemotherapy-induced neutropenia was effective and well tolerated in lymphoma patients in real-world clinical practice.