• Thomas Wolff, Holger Schulz, Christoph Losem, Dietmar Reichert, Hans-Jürgen Hurtz, Reiner Sandner, Johanna Harde, Sina Grebhardt, Karin Potthoff, Udo Mueller, and Thomas Fietz.
• Outpatient Center for Oncology Lerchenfeld, Hamburg, Germany.
• Eur. J. Haematol. 2019 Feb 1; 102 (2): 174-181.

ObjectiveThe prospective non-interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex® ), a glycopegylated granulocyte colony-stimulating factor, in cancer patients with different tumor entities undergoing chemotherapy in routine clinical practice. The primary objective was incidence of severe neutropenia, febrile neutropenia (FN), and neutropenia-associated complications.MethodNADIR was a national, multicenter, prospective NIS.ResultsHere, we present the data on patients with non-Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received ≥1 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, ≥1 severe neutropenia (grade 3/4) was reported in 115 (34.1%) patients and ≥1 event of FN documented in 15 (4.5%) patients. Grade 3/4 infections were reported in 22 (6.5%) patients overall. Most frequently reported adverse events (AEs) related to lipegfilgrastim in total were bone pain (5.4%), leukocytosis (2.1%), back pain (1.8%), platelet count decreased (1.2%), and myalgia (1.2%). Fatal serious AEs were documented in 9 (2.7%) patients; none were attributable to lipegfilgrastim.ConclusionProphylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials.© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

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