Veterinary Cooperative Oncology Group—Common Terminology Criteria for Adverse Events (VCOG‐CTCAE v2) following investigational therapy in dogs and cats

Abstract

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.

L-Asparaginase, Doxorubicin, Vincristine, and Prednisolone (LHOP) Chemotherapy as a First-Line Treatment for Dogs with Multicentric Lymphoma

“…Cyclophosphamide was replaced by l-asparaginase in the LHOP chemotherapy and can be held and used as a rescue agent. The primary goal for the treatment of relapsed lymphoma is palliation [ 13 ]. Owners may prefer oral medication at home rather than an injective formulation at the hospital when the tumour relapses.…”

“…The dogs were monitored for allergic reactions after l-asparaginase administration in the clinic for 30 min. Gastrointestinal toxicities were recorded by the owner at home and graded according to the Veterinary Cooperative Oncology Group Common Terminology Criteria for Adverse Events by the veterinarian [ 13 ]. The follow-up complete blood cell count was examined and recorded 1 week later.…”

Intratumoural Treatment of 18 Cytologically Diagnosed Canine High-Grade Mast Cell Tumours With Tigilanol Tiglate

“…Patients were restrained by hand during the procedure, sedation was permitted if considered necessary by the treating veterinarian, and personal protective equipment worn during administration of the TT dose (24, 29). Although this evaluation is retrospective in nature, these patients were assessed at regular intervals as part of larger cohort studies on Day 1, 7, 14, 28, and 84 for treatment response assessment and adverse event recording (37). Efficacy was assessed for each treated tumour at days 28 and 84 using response evaluation criteria in solid tumours (RECIST 1.1) and adverse events classified using the veterinary cooperative oncology group-common terminology criteria for adverse events (28,37).…”

“…Although this evaluation is retrospective in nature, these patients were assessed at regular intervals as part of larger cohort studies on Day 1, 7, 14, 28, and 84 for treatment response assessment and adverse event recording (37). Efficacy was assessed for each treated tumour at days 28 and 84 using response evaluation criteria in solid tumours (RECIST 1.1) and adverse events classified using the veterinary cooperative oncology group-common terminology criteria for adverse events (28,37). For this study, responses were classified as either a CR or grouped as a not complete response (not-CR) if the patient response was classified as a partial response, progressive disease or stable disease.…”

There and back again: Translating adoptive cell therapy to canine cancer and improving human treatment

“…The currently existing Veterinary Cooperative Oncology Group Common Terminology Criteria for Adverse Events allows a unified and codified framework for the grading of adverse events (AEs) associated with antineoplastic therapy in dogs 53 . Many AEs that could be associated with CRS in humans (e.g.…”