NADIR: A Non-Interventional Study on the Prophylaxis of Chemotherapy-Induced Neutropenia Using Lipegfilgrastim - First Interim Analysis.

Autor: Kurbacher CM; Gynäkologisches Zentrum Bonn-Friedensplatz, Bonn, Germany., Fietz T, Diel IJ, Egert M, Hurtz HJ, Lück A, Weide R, Salat C, Wolff T, Zaiss M, Klare P, Losem C, Illmer T, Weißenborn G, Steffens CC, Schulze M, Tesch H, Oskay-Oezcelik G, Teichmann B, Harde J, Scheuerlein RW
Jazyk: angličtina
Zdroj: Oncology research and treatment [Oncol Res Treat] 2015; Vol. 38 (5), pp. 221-9. Date of Electronic Publication: 2015 May 04.
DOI: 10.1159/000381631
Abstrakt: Background: The non-interventional study (NIS) NADIR was designed to assess the effectiveness and safety of lipegfilgrastim, a novel glycopegylated granulocyte-colony stimulating factor, in reducing the risk of both febrile and severe neutropenia.
Methods: Here, the interim analysis of NIS Nadir performed under real-world conditions at 80 oncology practices across Germany is reported. For a patient to be included, lipegfilgrastim at a subcutaneous single dose of 6 mg had to be administered during at least 1 cycle of the chemotherapy under consideration.
Results: The interim analysis included 224 patients. Median patient age was 61.1 years (interquartile range 51.2-70.2 years). Main tumor type was breast cancer followed by lung cancer, and non-Hodgkin's lymphoma (46.0, 13.4, and 10.7%, respectively). When lipegfilgrastim was given as primary prophylaxis, no patient developed febrile neutropenia (FN). 1.3% of patients developed FN when primary prophylaxis was withheld. Only 68.6% of patients undergoing chemotherapy and at high risk (> 20%) of developing FN were treated with lipegfilgrastim during the first cycle, exposing disparity between real-world practices and current treatment guidelines. Lipegfilgrastim was well tolerated. The only grade 3/4 treatment-related adverse event was anemia in 1 patient.
Conclusion: Lipegfilgrastim was effective and safe when administered for the prevention of chemotherapy-induced neutropenia under real-world conditions.
(© 2015 S. Karger GmbH, Freiburg.)
Databáze: MEDLINE
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