Comparison of the efficacy of a generic plerixafor versus Mozobil as adjunct peripheral blood stem cell mobilization agents in multiple myeloma patients.

IF 2.5 3区 医学 Q2 HEMATOLOGY Transfusion Pub Date : 2024-10-04 DOI:10.1111/trf.18033
Shan Yuan, Shelley Chang, Hoim Kim, Shirong Wang
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Abstract

Background: Plerixafor is an adjunct peripheral blood stem cell (PBSC) mobilization agent with well-demonstrated safety and efficacy. The routine use of the originator brand drug (Mozobil) has been limited by cost. This retrospective study was conducted to compare the mobilization efficacy of a lower-cost generic plerixafor and Mozobil in multiple myeloma (MM) patients.

Study design and methods: The study included two near-concurrent cohorts of MM patients mobilized with brand (n = 64) or generic (n = 61) plerixafor in addition to filgrastim. Collection and early engraftment outcomes were compared.

Results: The two cohorts had comparable distributions of sex, age, and weight. Previous treatment histories and proportions of upfront versus just-in-time plerixafor use were similar. There was no significant difference in their median overall cumulative total yield (106 CD34+ cells/kg) (brand, 5.91; generic, 5.80; p = .51). However, the generic cohort had a significantly higher median yield after the first dose (4.79 vs. 3.78, p = .03), and consequently lower median numbers of plerixafor doses (p = .001) and collection days (p = .002). Only 31.1% of patients in the generic arm required more than one dose versus 59.4% of patients in the brand arm (p = .006). All transplanted patients in the brand and generic arms (90.6% and 85.2% respectively, p = .42) achieved engraftment. There was no significant difference in their median times to platelet and neutrophil engraftment, nor their transfusion requirements during the first 30 days post-transplant.

Conclusion: The generic plerixafor produced comparable cumulative collection yields and early engraftment outcomes as Mozobil, but fewer doses and collection days were needed to reach collection goal.

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多发性骨髓瘤患者辅助外周血干细胞动员剂普乐沙福与莫佐比的疗效比较。
背景介绍普乐沙福是一种辅助性外周血干细胞(PBSC)动员剂,其安全性和有效性已得到充分证明。原研品牌药物(Mozobil)的常规使用一直受到成本的限制。这项回顾性研究旨在比较成本较低的普乐沙福和Mozobil对多发性骨髓瘤(MM)患者的动员疗效:研究包括两组几乎同时使用品牌(n = 64)或非专利(n = 61)plerixafor和filgrastim的MM患者。对采集结果和早期移植结果进行了比较:结果:两组患者的性别、年龄和体重分布相当。既往治疗史以及前期使用和适时使用普乐沙福的比例相似。两者的中位累积总产量(106 个 CD34+ 细胞/千克)无明显差异(品牌:5.91;非专利:5.80;P = .51)。然而,非专利药组首次用药后的中位得率明显更高(4.79 对 3.78,p = .03),因此普乐沙福用药剂量(p = .001)和采集天数(p = .002)的中位数也更低。只有31.1%的非专利组患者需要服用一次以上的剂量,而品牌组则有59.4%的患者需要服用一次以上的剂量(p = .006)。品牌组和非专利组的所有移植患者(分别为 90.6% 和 85.2%,p = .42)都实现了移植。他们的血小板和中性粒细胞移植中位时间以及移植后前30天的输血需求均无明显差异:结论:普通plerixafor的累积采集率和早期移植结果与Mozobil相当,但达到采集目标所需的剂量和采集天数更少。
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来源期刊
Transfusion
Transfusion 医学-血液学
CiteScore
4.70
自引率
20.70%
发文量
426
审稿时长
1 months
期刊介绍: TRANSFUSION is the foremost publication in the world for new information regarding transfusion medicine. Written by and for members of AABB and other health-care workers, TRANSFUSION reports on the latest technical advances, discusses opposing viewpoints regarding controversial issues, and presents key conference proceedings. In addition to blood banking and transfusion medicine topics, TRANSFUSION presents submissions concerning patient blood management, tissue transplantation and hematopoietic, cellular, and gene therapies.
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