Prophylaxis of Neutropenia with Lipegfilgrastim in Breast Cancer Patients with Dose-Dense Chemotherapy: Results of a Noninterventional Study on Therapeutic Routine in Germany (NADENS).

Kiechle, Marion; Schem, Christian; Lüftner, Diana; Hipp, Joachim; Stetzer, Eva; Köhler, Uwe

doi:10.1159/000524984

Klinik und Poliklinik für Frauenheilkunde (Prof. Kiechle)

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Document type:: Article; Journal Article
Author(s):: Kiechle, Marion; Schem, Christian; Lüftner, Diana; Hipp, Joachim; Stetzer, Eva; Köhler, Uwe
Title:: Prophylaxis of Neutropenia with Lipegfilgrastim in Breast Cancer Patients with Dose-Dense Chemotherapy: Results of a Noninterventional Study on Therapeutic Routine in Germany (NADENS).
Abstract:: INTRODUCTION: Noninterventional study (NIS) on application and effectiveness of primary G-CSF prophylaxis with lipegfilgrastim in primary breast cancer patients undergoing dose-dense (dd) or intense-dose-dense (idd) chemotherapy (CTx) regimen in daily clinical practice. METHODS: Prospective, multicenter, single-arm, NIS in 41 private practices and 27 hospitals in Germany. RESULTS: Data analysis of 282 patients with a mean age of 49 years (93.6% of patients <65 years) was performed. Hormone receptor status was triple negative in 29.8% of patients, and 81.9% of patients were HER2 negative. A total of 73.8% of patients received "EC dd → taxane CTx." Patients received lipegfilgrastim prophylaxis in 97.5% of 1,121 documented dd/idd cycles. Overall, the study registered 275 events of SN (CTCAE grade 3 or 4) and 9 events of FN. During the first dd cycle, SN occurred in 33.3% and FN in 1.1% of patients. CTx delay or dose reduction due to neutropenia was required in 2.5% of patients during the 4 dd cycles with lipegfilgrastim support. Overall, 314 adverse events (AEs) were reported from 107 patients and 27 serious AEs from 21 patients. None of the SAEs was "fatal," and CTCAE grade was mostly (89.6%) assessed as "1" or "2." According to the treating physicians, 99.3% of all patients benefitted from lipegfilgrastim prophylaxis, and tolerability was mostly rated "very good" or "good." CONCLUSION: These results suggest that primary lipegfilgrastim prophylaxis is effective and safe in clinical routine and is beneficial in primary breast cancer patients undergoing dd/idd-ETC CTx.
Journal title abbreviation:: Breast Care (Basel)
Year:: 2022
Journal volume:: 17
Journal issue:: 5
Pages contribution:: 508-513
Fulltext / DOI:: doi:10.1159/000524984
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/36684406
Print-ISSN:: 1661-3791
TUM Institution:: Klinik und Poliklinik für Frauenheilkunde
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Frauenheilkunde (Prof. Kiechle)2022