CAR-T(CAR-T)细胞疗法在非肿瘤性疾病中的应用
Chimeric antigen receptor T (CAR-T) cell therapy in non-oncological diseases.
CAR-T(CAR-T)细胞在血液系统恶性肿瘤中的应用推动了这种免疫治疗形式的显著进展。
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Mitigating inequity: ethically prioritizing patients for CAR T-cell therapy.
Mitigating inequity: ethically prioritizing patients for CAR T-cell therapy.
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CAR-T 细胞疗法(CAR-T)的生产能力和机构基础设施正面临压力,必须跟上不断增加的已获批产品和不断扩大的符合条件的患者群体,以提供这种可能挽救生命的治疗。
因此,许多细胞治疗项目必须做出艰难的决定:哪位患者应获得下一个可用的治疗名额。这种情况需要一个伦理框架来确保公平公正的决策。在本视角文章中,我们讨论了将“合理性问责”(A4R)——一个基于程序正义的优先排序框架——应用于我们机构CAR-T 名额有限的问题。
我们成立了一个涵盖多种血液恶性肿瘤的多学科工作组。通过多轮合作方参与,我们运用A4R指导原则确定了4项主要标准来对CAR-T 患者进行优先排序:医疗获益、并发症安全/风险、心理社会因素和医疗紧迫性。
我们制定了相关的措施/工具及实施流程。我们进一步讨论了公平与公正的伦理原则如何要求卫生系统采取一致的方法,不使医疗服务不足或代表性不足的人群处于不利地位,并支持克服护理障碍。出于对透明度和协作的承诺,我们向他人提供我们的工具,最好用于他们自己的A4R流程,并根据其独特环境调整这些工具。
我们希望我们的初步工作能够支持全球范围内该领域进一步研究的推进,旨在为所有潜在的CAR-T 候选者在他们寻求治疗的任何地方实现资源分配的公正。
Manufacturing capacity and institutional infrastructure to deliver chimeric antigen receptor T-cell therapies (CAR-T) are pressured to keep pace with the growing number of approved products and expanding eligible patient population for this potentially life-saving therapy. Consequently, many cell therapy programs must make difficult decisions about which patient should get the next available treatment slot.
This situation requires an ethical framework to ensure fair and equitable decision-making. In this perspective, we discuss the application of Accountability for Reasonableness (A4R), a priority-setting framework grounded in procedural justice, to the problem of limited CAR-T slots at our institution.
We formed a multidisciplinary working group spanning several hematological malignancies. Through multiple rounds of partner engagement, we used A4R guiding principles to identify 4 main criteria to prioritize patients for CAR-T: medical benefit, safety/risk of complications, psychosocial factors, and medical urgency. Associated measures/tools and an implementation process were developed.
We discuss further how ethical principles of fairness and equity demand a consistent approach within health systems that does not disadvantage medically underserved or underrepresented populations and supports overcoming barriers to care. In our commitment to transparency and collaboration, we make our tools available to others, ideally to be used to engage in their own A4R process, adapting the tools to their unique environments.
Our hope is that our preliminary work will support the advancement of further study in this area globally, aiming for justice in resource allocation for all potential CAR-T candidates, wherever they may seek care.
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