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前瞻性比较培非格司亭和利培格司亭联合化疗在 NHL 患者中动员 CD34 细胞的效果。

A prospective comparison of pegfilgrastim and lipegfilgrastim combined with chemotherapy in the mobilization of CD34 cells in NHL patients.

机构信息

Department of Medicine, Kuopio University Hospital, Kuopio, Finland.

Institute of Clinical Medicine, University of Eastern Finland, Kuopio, Finland.

出版信息

J Clin Apher. 2020 Aug;35(4):255-263. doi: 10.1002/jca.21785. Epub 2020 Apr 20.

Abstract

BACKGROUND

Autologous stem cell transplantation (auto-SCT) is a treatment approach in non-Hodgkin lymphoma (NHL) patients. The options for mobilization of CD34 cells to support high-dose therapy are granulocyte-colony stimulating factors (G-CSFs) alone or after chemotherapy. Limited data exist on the efficacy of lipegfilgrastim (LIPEG) in the mobilization field.

PATIENTS AND METHODS

The present prospective nonrandomized study compared LIPEG 6 mg (n = 40) with pegfilgrastim (PEG) 6 mg (n = 37) in the mobilization of blood CD34 cells after chemotherapy in NHL patients with comparable mobilizing chemotherapy and disease status before auto-SCT.

RESULTS

Significantly higher blood CD34 cell (B-CD34 ) counts were observed in the LIPEG group at the start of the first apheresis (44 vs 23 × 10 /L, P = .009), in line with a higher collection yield of the first apheresis (3.3 vs 2.1 × 10 /kg, P = .086) and total yield of CD34 cells (4.7 vs 2.9 × 10 /kg, P = .004). LIPEG proved to be a more effective G-CSF, resulting in a higher B-CD34 cell peak (60 vs 32 × 10 /L, P = .030) and higher proportion of excellent mobilizers (33% vs 8%, P = .008). The superiority of LIPEG was confirmed in the multivarite analysis concerning the CD34 cell yield of the first apheresis day (P = .010) and the total yield (P = .001).

CONCLUSION

The mobilization of blood grafts with LIPEG added to chemotherapy was associated with higher CD34 cell apheresis yields than with PEG. A randomized study is warranted to verify these findings.

摘要

背景

自体干细胞移植(auto-SCT)是治疗非霍奇金淋巴瘤(NHL)患者的一种方法。动员 CD34 细胞以支持大剂量治疗的选择是单独使用粒细胞集落刺激因子(G-CSFs)或在化疗后使用。关于利培格司特(LIPEG)在动员领域的疗效,数据有限。

患者和方法

本前瞻性非随机研究比较了化疗后 NHL 患者自体干细胞移植前,在动员化疗和疾病状态相似的情况下,LIPEG 6mg(n=40)与培非格司特(PEG)6mg(n=37)在动员血液 CD34 细胞中的作用。

结果

LIPEG 组在第一次单采开始时血液 CD34 细胞(B-CD34)计数明显更高(44 对 23×10/L,P=0.009),与第一次单采的更高采集产量(3.3 对 2.1×10/kg,P=0.086)和总 CD34 细胞产量(4.7 对 2.9×10/kg,P=0.004)一致。LIPEG 被证明是一种更有效的 G-CSF,导致更高的 B-CD34 细胞峰值(60 对 32×10/L,P=0.030)和更高比例的优秀动员者(33%对 8%,P=0.008)。在考虑第一次单采日 CD34 细胞产量(P=0.010)和总产量(P=0.001)的多变量分析中,LIPEG 的优越性得到了证实。

结论

在化疗中添加 LIPEG 动员血液移植物与更高的 CD34 细胞单采产量相关。需要进行随机研究来验证这些发现。

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