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细胞疗法试验中的患者报告结局:关注差距。

Patient-reported outcomes in adoptive cell-therapy trials: mind the gap.

机构信息

Department of Oncology, Immuno-Oncology Service, University Hospital of Lausanne, CHUV, Lausanne, Vaud, Switzerland.

Ludwig Cancer Research, Lausanne Branch, Lausanne, Vaud, Switzerland.

出版信息

J Immunother Cancer. 2022 Dec;10(12). doi: 10.1136/jitc-2022-006082.

Abstract

Adoptive cell therapies (ACT) have demonstrated promise in the treatment of patients with cancer, leading to long-lasting responses and, in some cases, even cure. Technological advances have brought these individualized therapies closer to reality, establishing them as credible therapeutic option. However, to date, few efforts have been made to understand patients' experience during ACT trials. Patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs), which are instruments used to report PROs, are increasingly being used in oncology to capture patients' perspective, provide real-world data on treatment safety, and support decision-making processes, such as health economic decisions. Due to the inherent complexity of ACT, the inclusion of PROMs in this field remains limited. In this commentary, we discuss the benefit of capturing PROs in ACT trials, the challenges of PROM administration and collection, and we propose simple and actionable recommendations to promote their adoption in ACT trials.

摘要

过继性细胞疗法 (ACT) 在癌症患者的治疗中显示出巨大的应用潜力,能产生持久的疗效,在某些情况下甚至能实现治愈。技术的进步使这些个体化疗法成为可能,ACT 逐渐成为一种可信的治疗选择。然而,迄今为止,人们很少关注患者在 ACT 临床试验中的体验。患者报告结局 (PRO) 和患者报告结局测量 (PROM) 是用于报告 PRO 的工具,目前在肿瘤学领域中被广泛应用,旨在捕捉患者的观点,提供治疗安全性的真实世界数据,并支持决策过程,如卫生经济学决策。由于 ACT 具有内在的复杂性,PROM 在该领域的应用仍然有限。在这篇评论中,我们讨论了在 ACT 临床试验中捕获 PRO 的益处,探讨了 PROM 管理和收集所面临的挑战,并提出了简单可行的建议,以促进其在 ACT 临床试验中的应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a94b/9743398/1f8cef67ffd7/jitc-2022-006082f01.jpg

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