The effect of lipegfilgrastim on hematopoietic reconstitution and supportive treatment after megachemotherapy with autologous peripheral blood stem cell transplantation in patients with lymphoproliferative malignancies
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Megachemotherapy with autologous peripheral blood stem cell transplantation (auto-PBSCT) is a standard treatment option in patients below 70 years of age with multiple myeloma (MM) as well as with relapsed and refractory lymphomas. Recombinant granulocyte colony-stimulating factors (G-CSF) are commonly used to accelerate bone marrow recovery after chemotherapy and reduce the duration of severe neutropenia. Lipegfilgrastim is a glicopegylated G-CSF with prolonged action registered for adult patients with malignant neoplasms in order to reduce the duration of neutropenia and the incidence of febrile neutropenia (FN). So far, there is not enough data to confirm the effectiveness and safety of this drug in patients with hematological malignancies including those undergoing auto-PBSCT. The aim of this study was to determine the effect of lipegfilgrastim on hematopoietic regeneration and supportive care after auto-PBSCT in patients with lymphoproliferative malignancies. The study population consisted of 30 patients (12 female and 18 male; median age: 50 years ± 13), including 13 patients with MM, 5 with Hodgkin’s lymphoma (HL) and 12 with non-Hodgkin’s lymphoma (nHL). The median number of transplanted CD34+ cells was 3.96 ± 1.56 × 10^6/kg of body mass. On day +1 after auto-PBSCT, the patients received lipegfilgrastim in a single 6 mg subcutaneous injection. The control group consisted of 32 patients (13 female and 19 male; median age: 50 years ± 6.4), including 13 with MM, 8 with HL and 11 with nHL, who received subcutaneous filgrastim in a dose of 5 μg/kg/day from day +1 after transplantation and continued to an absolute neutrophil count (ANC) > 1.5 × 10^9/L. There was no significant difference in the time of regeneration ANC > 0.5 × 10^9/L which was 10.65 ± 1.00 vs. 11.51 ± 2.29 days respectively in the study and control group. Similar observations were noted regarding the duration of febrile neutropenia (2.16 ± 2.22 vs. 1.70 ± 4.17 days; p = 0.998), regeneration of platelets (PLT) > 20 × 10^9/L (12.41 ± 2.41 vs. 13.82 ± 4.48 days; p = 0.233) and demand for transfusion of red blood cells (0.76 ± 1.07 vs. 1.33 ± 2.33 units; p = 0.414) and platelets (11.5 ± 6.9 vs. 19.2 ± 17.7 units; p = 0.08). Different results were observed for the length of hospitalization, which was significantly shorter in the lipegfilgrastim group (16.14 ± 14 vs. 24.46 ± 6.79 days; p = 0.000). Lipegfilgrastim is as effective as filgrastim with regards to the regeneration of the hematopoietic system, duration of febrile neutropenia, demand for transfusion of blood products and significantly reduces hospitalization in patients with lymphoproliferative malignancies after auto-PBSCT.
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