Veterinary Cooperative Oncology Group-Common Terminology Criteria for Adverse Events (VCOG-CTCAE v2) following investigational therapy in dogs and cats.
Veterinary Cooperative Oncology Group-Common Terminology Criteria for Adverse Events (VCOG-CTCAE v2) following investigational therapy in dogs and cats.
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DOI：
10.1111/vco.12677
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发表时间：
2021-06
影响因子：
2.1
通讯作者：
Mazcko C
中科院分区：
文献类型：
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作者：
LeBlanc AK;Atherton M;Bentley RT;Boudreau CE;Burton JH;Curran KM;Dow S;Giuffrida MA;Kellihan HB;Mason NJ;Oblak M;Selmic LE;Selting KA;Singh A;Tjostheim S;Vail DM;Weishaar KM;Berger EP;Rossmeisl JH;Mazcko C
更新后的VCOG-CTCAE v2指南包含自2011年发布的最后一次更新（v1.1）以来的几项重要更新和补充，并于2016年在兽医和比较肿瘤学中发表。由于兽医肿瘤协作组（VCOG）不再是一个活跃的实体，因此咨询了VCOG‐CTCAE v1.0和v1.1的原始作者和贡献者以获取输入，并寻求其他共同作者扩展和细化不良事件（AE）类别。VCOG‐CTCAE v2包括扩展的神经学、心脏和免疫学AE章节，并增加了手术特异性AE。我们的目的是，通过纳入来自ACVIM亚专业和美国兽医外科学院的其他作者，我们可以更全面地捕获在各种疾病状态、临床场景和身体系统中进行的临床研究期间观察到的AE。我们还希望这些更新的兽医CTCAE指南将在兽医实践中以及在评估各种疾病动物新治疗策略的临床试验中提供更好的应用和易用性。在整个修订过程中，我们努力确保每个AE类别的分级结构反映了用于确定剂量限制性事件的决策过程。由于I期试验的决定是基于这些标准并最终确定最大耐受剂量，因此对任何新药注册或申请的标准剂量建议都有影响。本文件应定期更新，以反映在兽医患者中进行的临床研究的持续应用。
The updated VCOG‐CTCAE v2 guidelines contain several important updates and additions since the last update (v1.1) was released in 2011 and published within Veterinary and Comparative Oncology in 2016. As the Veterinary Cooperative Oncology Group (VCOG) is no longer an active entity, the original authors and contributors to the VCOG‐CTCAE v1.0 and v1.1 were consulted for input, and additional co‐authors sought for expansion and refinement of the adverse event (AE) categories. VCOG‐CTCAE v2 includes expanded neurology, cardiac and immunologic AE sections, and the addition of procedural‐specific AEs. It is our intent that, through inclusion of additional authors from ACVIM subspecialties and the American College of Veterinary Surgery, that we can more comprehensively capture AEs that are observed during clinical studies conducted across a variety of disease states, clinical scenarios, and body systems. It is also our intent that these updated veterinary CTCAE guidelines will offer improved application and ease of use within veterinary practice in general, as well as within clinical trials that assess new therapeutic strategies for animals with a variety of diseases. Throughout the revision process, we strived to ensure the grading structure for each AE category was reflective of the decision‐making process applied to determination of dose‐limiting events. As phase I trial decisions are based on these criteria and ultimately determine the maximally tolerated dose, there is impact on standard dosing recommendations for any new drug registration or application. This document should be updated regularly to reflect ongoing application to clinical studies carried out in veterinary patients.