Prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non-Hodgkin lymphoma (NADIR study)
| Autor: | Thomas Wolff, Holger Schulz, Sina Grebhardt, Dietmar Reichert, Karin Potthoff, Reiner Sandner, Thomas Fietz, Udo Mueller, Johanna Harde, Hans-Jürgen Hurtz, Christoph Losem |
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| Rok vydání: | 2018 |
| Předmět: |
myalgia
Adult Male medicine.medical_specialty Adolescent Filgrastim medicine.medical_treatment Comorbidity Neutropenia Polyethylene Glycols 03 medical and health sciences Young Adult 0302 clinical medicine hemic and lymphatic diseases Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Prospective Studies Chemotherapy-Induced Febrile Neutropenia Adverse effect Bone pain Aged Febrile Neutropenia Aged 80 and over Chemotherapy business.industry Incidence Lymphoma Non-Hodgkin Hematology General Medicine Middle Aged medicine.disease Granulocyte colony-stimulating factor Treatment Outcome 030220 oncology & carcinogenesis Female medicine.symptom business Lipegfilgrastim Febrile neutropenia 030215 immunology |
| Zdroj: | European journal of haematology. 102(2) |
| ISSN: | 1600-0609 |
| Popis: | Objective The 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. Method NADIR was a national, multicenter, prospective NIS. Results Here, 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. Conclusion Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials. |
| Databáze: | OpenAIRE |
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