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.
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http://dx.doi.org/10.21873/anticanres.14782 | DOI Listing |
Front Oncol
May 2021
Department of Internal Medicine I, University Hospital St. Poelten, Karl Landsteiner, University of Health Sciences, St. Poelten, Austria.
Lipegfilgrastim is a long-acting glycopegylated granulocyte-colony stimulating factor (G-CSF) approved for the management of chemotherapy-induced neutropenia. In general, there is little information on the use of any G-CSFs specifically in patients with urological malignancies receiving chemotherapy. This report combines information from two prospective non-interventional studies on the prophylactic use of lipegfilgrastim in urological cancer patients receiving chemotherapy in the real-world setting.
View Article and Find Full Text PDFBMJ Support Palliat Care
May 2021
Department of pharmacy, The first affiliated hospital of zhengzhou university, Zhengzhou, Henan, China
Objectives: To investigate the efficacy and safety of pegfilgrastim administered on the day of chemotherapy completion (same day) versus at least 1 day after chemotherapy (next day).
Methods: We searched relevant literature published before April 2020 from the following databases: Embase, PubMed, Cochrane databases and Web of science.
Results: One randomised controlled trial and 12 observational studies met all of the prespecified criteria for eligibility.
Anticancer Res
January 2021
Casa Solievo della Sofferenza, San Giovanni Rotondo, Italy.
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.
Ann Oncol
September 2017
Breast Center, Department of Obstetrics and Gynecology, and CCCLMU, University of Munich (LMU), Munich, Germany.
Background: Following the functional and physicochemical characterization of a proposed biosimilar, comparative clinical studies help to confirm biosimilarity by demonstrating similar safety and efficacy to the reference product in a sensitive patient population.
Patients And Methods: LA-EP2006 is a proposed biosimilar that has been developed for pegfilgrastim, a long-acting form of granulocyte colony-stimulating factor for the prevention of neutropenia. The current analysis reports data pooled from two independent, multinational, prospective, randomized, controlled, double-blind phase III studies of similar design comparing the safety and efficacy of reference pegfilgrastim with LA-EP2006 in patients with breast cancer receiving myelotoxic (neo)adjuvant TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy and requiring granulocyte colony-stimulating factor.
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