A comparative effectiveness study of lipegfilgrastim in multiple myeloma patients after high dose melphalan and autologous stem cell transplant |
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| Authors: | Massimo Martino Mercedes Gori Giovanni Tripepi Anna Grazia Recchia Michele Cimminiello Pasquale Fabio Provenzano Virginia Naso Anna Ferreri Tiziana Moscato Giuseppe Console Barbara Loteta Giuseppe Alberto Gallo Massimo Gentile Vanessa Innao Marco Rossi Antonella Morabito Iolanda Donatella Vincelli Donato Mannina Annalisa Pitino |
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| Affiliation: | 1.Stem Cell Transplant Program, Department of Hemato-Oncology and Radiotherapy, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy;2.CNR-IFC, Rome, Italy;3.CNR-IFC, Research Unit of Reggio Calabria, Reggio Calabria, Italy;4.Department of Hematology, Unità di Ricerca Biotecnologica, Cosenza, Italy;5.Hematology Unit, Azienda Ospedaliera Regionale S. Carlo - Ospedale San Carlo, Potenza, Italy;6.Hematology Unit, Department of Hemato-Oncology, Ospedale Annunziata, Cosenza, Italy;7.Division of Hematology, Department of Department of Human Pathology in Adulthood and Childhood “Gaetano Barresi”, University of Messina, Messina, Italy;8.Department of Experimental and Clinical Medicine, Magna Gr?cia University, Catanzaro, Italy;9.Pharmacy Unit, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy;10.Hematology Unit, Department of Hemato-Oncology and Radiotherapy, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy;11.Hematology Unit, Azienda Ospedaliera, Papardo, Messina, Italy |
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| Abstract: | G-CSF administration after high-dose chemotherapy and autologous stem cell transplantation (ASCT) has been shown to expedite neutrophil recovery. Several studies comparing filgrastim and pegfilgrastim in the post-ASCT setting concluded that the two are at least equally effective. Lipegfilgrastim (LIP) is a new long-acting, once-per-cycle G-CSF. This multicentric, prospective study aimed to describe the use of LIP in multiple myeloma patients receiving high-dose melphalan and autologous stem cell transplantation (ASCT) and compare LIP with historic controls of patients who received short-acting agent (filgrastim [FIL]). Overall, 125 patients with a median age of 60 years received G-CSF after ASCT (80 patients LIP on day 1 post-ASCT and 45 patients FIL on day 5 post-ASCT). The median duration of grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 10 [9]/L) was 5 days in both LIP and FIL groups, whereas the median number of days to reach ANC ≥ 0.5 × 10 [9]/L was 10% lower in the LIP than in the FIL group (10 vs 11 days), respectively. Male sex was significantly associated with a faster ANC ≥ 0.5 × 10 [9] L response (p = 0.015). The incidence of FN was significantly lower in the LIP than in the FIL group (29% vs 49%, respectively, p = 0.024). The days to discharge after ASCT infusion were greater in patients with FN (p < 0.001). The study indicates that LIP had a shorter time to ANC recovery and is more effective than FIL for the prevention of FN in the ASCT setting. |
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