用于调动多发性骨髓瘤患者干细胞的原研药与普乐沙福仿制药的比较

IF 0.9 4区 医学
Süreyya Yiğit Kaya, Yaşa Gül Mutlu, Orhan Kemal Yücel, İlknur Nizam Özen, Ünal Ataş, Elif Melek, Senem Maral, Volkan Karakuş, Leylagül Kaynar, Ömür Gökmen Sevindik
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引用次数: 0

摘要

本研究调查了在接受ASCT的多发性骨髓瘤患者中,与原研药plerixafor(Mozobil - Sanofi)相比,仿制药plerixafor(Pleksor - Gen Pharma)的疗效和安全性。共有来自三个中心的59名患者在2018年至2023年期间接受了ASCT,他们被纳入并分为两组:Mozobil(M)组(n = 32)和Pleksor(P)组(n = 27)。普乐可复作为一种适时方法,与粒细胞集落刺激因子(G-CSF)单独或与环磷酰胺(Cy)+ G-CSF一起进行动员。研究旨在评估动员成功率和移植动力学。两组患者在年龄、性别、RT病史、既往治疗方案、移植前来那度胺周期等方面无统计学差异(P分别为0.778、0.165、0.520、0.094、0.530)。然而,来那度胺在P组的暴露率明显更高(18.8% vs. 81.5%,p < 0.001)。两组获得的 CD34 + 细胞总产量相似,没有发现与普乐沙福相关的严重副作用。P组的血小板中位移植时间更长,而两组的中性粒细胞移植时间相似。这项研究表明,普通型plerixafor对骨髓瘤患者的疗效相当,表明它是一种具有成本效益的替代药物,且安全性相似。这些研究结果为在特定患者群中使用普乐沙福提供了更多证据,强调了它在唯一的多发性骨髓瘤患者群中进行ASCT的有效性和安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Original vs. Generic Plerixafor for the Mobilization of Stem Cells in Multiple Myeloma Patients

This study investigates the efficacy and safety of generic plerixafor (Pleksor – Gen Pharma) compared to the original plerixafor (Mozobil - Sanofi) in patients with multiple myeloma undergoing ASCT. A total of 59 patients from three centers, who underwent ASCT between 2018 and 2023, were included and divided into two groups: Mozobil (M) group (n = 32) and Pleksor (P) group (n = 27). Plerixafor was administered as a just-in-time approach with granulocyte-colony stimulating factor (G-CSF) alone or with cyclophosphamide (Cy) + G-CSF mobilization. The study aimed to assess mobilization success and engraftment kinetics. There was no statistically significant difference between the two groups in terms of age, gender, RT history, previous lines of treatment, pretransplant lenalidomide cycles (p = 0.778, 0.165, 0.520, 0.094, 0.530, respectively). However, lenalidomide exposure was significantly higher in P group (18,8% vs. 81,5%, p < 0.001). Both groups achieved a similar total yield of CD34 + cells, and no serious side effects related to plerixafor were noted. Median platelet engraftment time was longer in P group, while neutrophil engraftment time was similar in both groups. This study demonstrates the comparable efficacy of generic plerixafor in myeloma patients, suggesting that it can be a cost-effective alternative with a similar safety profile. These findings contribute to the body of evidence on the use of generic plerixafor in specific patient cohorts, emphasizing its efficacy and safety for ASCT in a sole multiple myeloma patient cohort.

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来源期刊
自引率
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发文量
82
期刊介绍: Indian Journal of Hematology and Blood Transfusion is a medium for propagating and exchanging ideas within the medical community. It publishes peer-reviewed articles on a variety of aspects of clinical hematology, laboratory hematology and hemato-oncology. The journal exists to encourage scientific investigation in the study of blood in health and in disease; to promote and foster the exchange and diffusion of knowledge relating to blood and blood-forming tissues; and to provide a forum for discussion of hematological subjects on a national scale. The Journal is the official publication of The Indian Society of Hematology & Blood Transfusion.
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