Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study

Mostra el registre complet Registre parcial de l'ítem

• dc.contributor.author Link, Hartmut
• dc.contributor.author Illerhaus, G.
• dc.contributor.author Martens, U.M.
• dc.contributor.author Salar Silvestre, Antonio
• dc.contributor.author Depenbusch, R.
• dc.contributor.author Köhler, A.
• dc.contributor.author Engelhardt, M.
• dc.contributor.author Mahlmann, S.
• dc.contributor.author Zaiss, M.
• dc.contributor.author Lammerich, A.
• dc.contributor.author Bias, P.
• dc.contributor.author Buchner, A.
• dc.date.accessioned 2022-02-18T07:39:04Z
• dc.date.available 2022-02-18T07:39:04Z
• dc.date.issued 2021
• dc.description.abstract Background: Lipegfilgrastim has been shown to be non-inferior to pegfilgrastim for reduction of the duration of severe neutropenia (DSN) in breast cancer patients. This open-label, non-inferiority study assessed the efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (NHL) at high risk for chemotherapy-induced neutropenia. Patient and methods: One hundred and one patients (median age, 75 years) were randomized to lipegfilgrastim or pegfilgrastim (6 mg/cycle) during six cycles of R-CHOP21. Results: Lipegfilgrastim was non-inferior to pegfilgrastim for the primary efficacy endpoint, reduction of DSN in cycle 1. In the per-protocol population, mean (standard deviation) DSN was 0.8 (0.92) and 0.9 (1.11) days in the two groups, respectively; the adjusted mean difference between groups was - 0.3 days (95% confidence interval, - 0.70 to 0.19). Non-inferiority was also demonstrated in the intent-to-treat population. The incidence of severe neutropenia in cycle 1 was 51% (21/41) in the lipegfilgrastim group and 52% (23/44) in the pegfilgrastim group. Very severe neutropenia (ANC < 0.1 × 109/L) in cycle 1 was reported by 5 (12%) patients in the lipegfilgrastim group and 8 (18%) patients in the pegfilgrastim group. However, over all cycles, febrile neutropenia (strict definition) was reported by only 1 (2%) patient in each treatment group (during cycle 1 in the lipegfilgrastim group and cycle 6 in the pegfilgrastim group). The mean time to absolute neutrophil count recovery (defined as ≥ 2.0 × 109/L) was 8.3 and 9.4 days in the two groups, respectively. Serious adverse events occurred in 46% of patients in each group; none were considered treatment-related. Eight patients died during the study (2 in the lipegfilgrastim group, 5 in the pegfilgrastim group, and 1 who died before starting study treatment). No deaths occurred during the treatment period, and all were considered to be related to the underlying disease. Conclusions: This study shows lipegfilgrastim to be non-inferior to pegfilgrastim for the reduction of DSN in elderly patients with aggressive B cell NHL receiving myelosuppressive chemotherapy, with a comparable safety profile.
• dc.format.mimetype application/pdf
• dc.identifier.citation Link H, Illerhaus G, Martens UM, Salar A, Depenbusch R, Köhler A, et al. Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study. Support Care Cancer. 2021 May; 29(5): 2519-27. DOI: 10.1007/s00520-020-05711-7
• dc.identifier.doi http://dx.doi.org/10.1007/s00520-020-05711-7
• dc.identifier.issn 0941-4355
• dc.identifier.uri http://hdl.handle.net/10230/52526
• dc.language.iso eng
• dc.publisher SpringerOpen
• dc.rights Copyright © The Author(s) 2020. Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by/4.0/
• dc.subject.keyword B cell non-Hodgkin lymphoma
• dc.subject.keyword Chemotherapy-induced neutropenia
• dc.subject.keyword Febrile neutropenia
• dc.subject.keyword Granulocyte colony
• dc.subject.keyword Lipegfilgrastim
• dc.subject.keyword Pegfilgrastim
• dc.subject.keyword Stimulating factor (G-CSF)
• dc.title Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymphoma (B-NHL): results of the randomized, open-label, non-inferiority AVOID neutropenia study
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion