Efficacy and safety of lipegfilgrastim versus pegfilgrastim in elderly patients with aggressive B cell non-Hodgkin lymph
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ORIGINAL ARTICLE
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 Hartmut Link 1 & G. Illerhaus 2 & U. M. Martens 3 & A. Salar 4 & R. Depenbusch 5 & A. Köhler 6 & M. Engelhardt 7 & S. Mahlmann 8 & M. Zaiss 9 & A. Lammerich 10 & P. Bias 10 & A. Buchner 10 Received: 30 April 2020 / Accepted: 20 August 2020 # The Author(s) 2020
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 chemotherapyinduced 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
The results presented in this paper were partly presented as a poster presentation at ESMO, Munich, Germany, 19–23 October 2018. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00520-020-05711-7) contains supplementary material, which is available to authorized users. * Hartmut Link [email protected]
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Hematology and Oncology Collective Practice, Asklepios Clinic Specialist Medical Centre Langen, Langen, Germany
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Internal Medicine Clinic I, Hematology, Oncology and Stem Cell Transplantation, University Clinic, Faculty of Freiburg, Freiburg, Germany
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Private Practice Hematology Medical Oncology, Finkenhain 8, 67661 Kaiserslautern, Germany
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Hematology, Oncology and Palliative Medi
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