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2016-2019 年免疫毒性评估小组报告:免疫相关不良事件的协作管理,一项观察性临床研究。

The 2016-2019 ImmunoTOX assessment board report of collaborative management of immune-related adverse events, an observational clinical study.

机构信息

Gustave Roussy, Université Paris-Saclay, Département des Innovations Thérapeutiques et Essais Précoces, Villejuif, France.

Assistance Publique - Hôpitaux de Paris, Hôpital Bicêtre, Service de Médecine Interne and Immunologie clinique, Le Kremlin-Bicêtre, France.

出版信息

Eur J Cancer. 2020 May;130:39-50. doi: 10.1016/j.ejca.2020.02.010. Epub 2020 Mar 12.

Abstract

PURPOSE

We investigated the activities of an ImmunoTOX board, an academic, multidisciplinary group of oncologists and organ specialists that adopts a real-life, case-by-case approach in the management of patients with immune-related adverse events (irAEs).

EXPERIMENTAL DESIGN

The ImmunoTOX assessment board was set up in 2016 at Gustave Roussy in France. It meets every 2 weeks to discuss the case-by-case management of patients presenting with irAEs. Here, we describe the ImmunoTOX board's activities between 2016 and 2019.

RESULTS

Over study period, 398 requests (concerning 356 patients) were submitted to the ImmunoTOX board. Most of the requests concerned the putative causal link between immunotherapy and the irAE (n = 148, 37%), followed by possible retreatment after temporary withdrawal because of an adverse event (n = 109, 27%), the clinical management of complex situations (n = 100, 25%) and the initiation of immunotherapy in patients with pre-existing comorbidities (n = 41, 10%). The ImmunoTOX board discerned 273 irAEs. The five organ systems most frequently involved by irAEs were lung (n = 58, 21%), gastrointestinal tract (n = 36, 13%), liver or biliary tract (n = 33, 12%), musculoskeletal system (n = 27, 10%), and nervous system (n = 23, 8%). The time to occurrence was shorter for severe irAEs (grade III and VI) than for mild irAEs (grades I and II), with medians of 47 and 91 days, respectively (p = 0.0216).

CONCLUSION

The main medical needs in the management of irAEs involved the lung organ. Severe irAEs were expected to occur earlier than mild irAEs. This real-life study can help to better estimate medical needs and therefore help to assess the management of irAEs.

摘要

目的

我们调查了 ImmunoTOX 委员会的活动,该委员会是一个由肿瘤学家和器官专家组成的学术性多学科小组,在管理免疫相关不良事件(irAEs)患者时采用现实生活中的案例方法。

实验设计

ImmunoTOX 评估委员会于 2016 年在法国古斯塔夫·鲁西(Gustave Roussy)成立。它每两周开会一次,讨论出现 irAEs 的患者的个案管理。在这里,我们描述了 2016 年至 2019 年期间 ImmunoTOX 委员会的活动。

结果

在研究期间,向 ImmunoTOX 委员会提交了 398 份请求(涉及 356 名患者)。大多数请求涉及免疫治疗与 irAE 之间的因果关系(n=148,37%),其次是因不良事件暂时停药后可能的重新治疗(n=109,27%),复杂情况的临床管理(n=100,25%)以及患有预先存在的合并症的患者开始免疫治疗(n=41,10%)。ImmunoTOX 委员会辨别了 273 个 irAE。最常涉及 irAE 的五个器官系统是肺(n=58,21%),胃肠道(n=36,13%),肝或胆道(n=33,12%),肌肉骨骼系统(n=27,10%)和神经系统(n=23,8%)。严重 irAE(III 级和 VI 级)的发生时间短于轻度 irAE(I 级和 II 级),中位数分别为 47 天和 91 天(p=0.0216)。

结论

irAE 管理中主要的医疗需求涉及肺部器官。严重的 irAE 比轻度 irAE 更早发生。这项真实研究可以帮助更好地估计医疗需求,从而帮助评估 irAE 的管理。

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