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嵌合抗原受体 T 细胞治疗难治性侵袭性 B 细胞淋巴瘤。

CD19 Chimeric Antigen Receptor Therapy for Refractory Aggressive B-Cell Lymphoma.

机构信息

Dana-Farber Cancer Institute, Boston, MA.

出版信息

J Clin Oncol. 2019 Feb 1;37(4):328-335. doi: 10.1200/JCO.18.01457. Epub 2018 Dec 13.

Abstract

PURPOSE

Anti-CD19-directed chimeric antigen receptor (CAR) T-cell therapy has had a resounding effect on the treatment of chemotherapy-insensitive aggressive B-cell non-Hodgkin lymphoma (B-NHL). There are now two US Food and Drug Administration (FDA)-approved products available for treating these patients, and a third product is expected to be approved in the coming months. The question remains: Is there a preferred or best product for my patient? However, answering that question is more complicated than simply balancing the reported efficacy and toxicity results.

DESIGN

This review outlines potential confounding factors involving the three products and their pivotal clinical trials and highlights additional considerations of manufacturing reliability and overall cost that must be considered when weighing one product against another. It will also review the directions in which the field is moving and strategies being examined to improve efficacy as well as toxicity.

CONCLUSION

Because a randomized three-arm clinical trial is unlikely, a product may have to be chosen on the basis of results from treatment centers that have experience with all three products. But by the time those results are available, they are likely to be outdated because, given the rapid evolution of the field, the next product will probably have been identified.

摘要

目的

抗 CD19 嵌合抗原受体 (CAR) T 细胞疗法在治疗化疗耐药侵袭性 B 细胞非霍奇金淋巴瘤 (B-NHL)方面取得了显著成效。目前已有两种获得美国食品和药物管理局 (FDA)批准的产品可用于治疗这些患者,预计未来几个月将批准第三种产品。问题仍然存在:对于我的患者,哪种产品是首选或最佳产品?然而,要回答这个问题,不仅仅要权衡报告的疗效和毒性结果,还需要考虑更复杂的因素。

设计

本综述概述了涉及这三种产品及其关键临床试验的潜在混杂因素,并强调了在权衡一种产品与另一种产品时必须考虑制造可靠性和总体成本等额外考虑因素。它还将回顾该领域的发展方向以及正在研究的提高疗效和降低毒性的策略。

结论

由于不太可能进行随机三臂临床试验,因此可能需要根据具有所有三种产品经验的治疗中心的结果来选择产品。但是,等到这些结果可用时,它们可能已经过时了,因为鉴于该领域的快速发展,可能已经确定了下一种产品。

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