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药师与 CAR-T 细胞的法国经验:法国肿瘤药学学会(SFPO)的一项研究

英文原题:The French Experience of Pharmacists and CAR T-Cells: A Study of the French Society of Oncology Pharmacy (SFPO).

查看英文原题

The French Experience of Pharmacists and CAR T-Cells: A Study of the French Society of Oncology Pharmacy (SFPO).

PubMed 2025/11/01(内容时间) Hematol Oncol Q1 · IF 4.1(JCR 2025)

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中文摘要

本研究旨在介绍法国首批招募中心在axi-cel治疗最初3年中静脉至静脉周转时间的经验,并阐述药师发挥的作用。研究者回顾性收集2019年1月至2021年12月法国最初12家获授权中心中,患者接受两线全身治疗后使用商业化axi-cel的静脉至静脉周转时间数据。医院药师通过流程数据库确保各步骤均得到前瞻性追踪记录。在细胞单采数据库登记的562例意向治疗患者中,有501例(89.1%)最终接受axi-cel输注。静脉至静脉中位时间缩短了4天,主要得益于缩短了从单采到产品放行的间隔。经过3年实践,中位静脉至静脉时间达到36天;相比之下,加拿大、美国和以色列报告的时间为29–34天,这些国家的生产中心与医院距离较法国更近。招募患者最多的前5家中心周转时间最短。法国的经验可为其他欧洲中心提供范例,尤其是在部署药师、借此优化CAR-T 及其他基因和细胞治疗患者诊疗流程方面。

展开英文摘要原文

The aim of this study was to describe the initial 3-year experience in vein-to-vein time for axi-cel therapy and the role of pharmacists in the first recruiting French centers. Retrospective observational data were collected for vein-to-vein time for commercial axi-cel after 2 lines of systemic therapy between January 2019 and December 2021 in the first 12 authorized French centers. Hospital pharmacists used a circuit database to ensure the prospective traceability at all steps. Totally 501 of the 562 intention-to-treat registrations on the database for cytapheresis (89,1%) led to the infusion of axi-cel.

Median vein-to-vein time was shortened by 4 days. This was mainly due to tightening the interval from apheresis to release. The 36-day median vein-to-vein time achieved after 3 years' experience should be compared to the 29-34 days reported in Canada, the USA and Israel, where manufacturing sites are geographically closer to hospital centers than they are in France.

The top 5 recruiting centers had the shortest vein-to-vein times. This French experience may serve as a model for other European centers, notably as regards deployment of pharmacists to improve the patient pathway with CAR T-cells and other gene and cellular therapies.

论文信息

作者
Schwiertz V、de Jorna R、Quintard A、Lester MA、Pinturaud M、Cormier N、D'Huart E、Fougereau E
单位
SFPO Société Française de Pharmacie Oncologique, Paris, France.France
文献类型
观察性研究 · 多中心研究
期刊
Hematological oncology2025 Nov
原文标识
PubMed 41126598 · DOI 10.1002/hon.70144