生物仿制药 pegfilgrastim 对接受大剂量化疗和自体干细胞移植后的淋巴瘤患者的疗效:一项真实生活研究

Barbara Loteta, A. Pitino, Martina Pitea, C. Alati, Giovanni Tripepi, Maria Caterina Micó, Maria Pellicano', Francesca Cogliandro, Gaetana Porto, Giorgia Policastro, Giovanna Utano, Ilaria Maria Delfino, Annalisa Sgarlata, Anna Scopelliti, Aurora Idato, Giovanni Laenza, M. Altomonte, G. D’Arrigo, Mercedes Gori, Massimo Martino
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引用次数: 0

摘要

评估生物仿制药(BIO)培非格拉司汀(PEG)对自体干细胞移植(ASCT)后淋巴瘤患者的疗效。这项研究的主要终点是发热性中性粒细胞减少症(FN)的发生率和中性粒细胞移植时间。大多数患者为男性(67.4%),中位年龄为48岁。66名患者(76.7%)出现发热性中性粒细胞减少症,大多数发热为1-2级。中性粒细胞移植的中位时间为 9 天。FN的发生率因淋巴瘤类型而异(P值<0.01),非霍奇金淋巴瘤(NHL)的发生率高于霍奇金淋巴瘤(HL)。在达到中性粒细胞移植的时间方面,非霍奇金淋巴瘤和霍奇金淋巴瘤之间没有统计学差异。住院时间最短为9天,最长为34天。虽然这项研究存在很大的局限性,即没有随机分组,也没有对照组,但它强调了BIO-PEG制剂对接受ASCT的淋巴瘤患者的有效性和安全性。
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Effectiveness of biosimilar pegfilgrastim in patients with lymphoma after high-dose chemotherapy and autologous stem cell transplantation: a real-life study
To evaluate the efficacy of biosimilar (BIO) pegfilgrastim (PEG) in lymphoma patients after autologous stem cell transplantation (ASCT).86 consecutive lymphoma patients who received BIO/PEG after ASCT were assessed. The primary endpoints of this study were the incidence of febrile neutropenia (FN) and time to neutrophil engraftment.Most patients were males (67.4%) with a median age of 48 years. FN occurred in 66 patients (76.7%), and most of the fever was grade 1-2. The median time to neutrophil engraftment was 9 days. The incidence of FN differs based on lymphoma type (p-value <0.01) and was higher in non-Hodgkin lymphoma (NHL) than in Hodgkin Lymphoma (HL). No statistical difference was found between NHL and HL regarding the time to reach the neutrophil engraftment. Hospitalization lasted from a minimum of 9 to a maximum of 34 days. The restricted mean time to discharge was 15.9 days (95%CI 14-16), without differences based on lymphoma type.Although the study has the significant limitation of not being randomized and not having a control arm, it highlights the efficacy and safety of a BIO-PEG formulation in patients with Lymphoma and undergoing ASCT.
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