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.
1 March 2014 in Journal of Veterinary Internal Medicine
Background: Many chemotherapy protocols have been reported for treatment of canine appendicular osteosarcoma (OSA), but outcome comparisons in a single population are lacking. Objective: To evaluate the effects of protocol and dose intensity (DI) on treatment outcomes for carboplatin and doxorubicin-based chemotherapy protocols. Animals: Four hundred and seventy dogs with appendicular OSA. Methods: A retrospective cohort study was performed comprising consecutive dogs treated (1997–2012) with amputation followed by 1 of 5 chemotherapy protocols: carboplatin 300 mg/m2 IV q21d for 4 or 6 cycles (CARBO6), doxorubicin 30 mg/m2 IV q14d or q21d for 5 cycles, and alternating carboplatin 300 mg/m2 IV and doxorubicin 30 mg/m2 IV q21d for 3 cycles. Adverse events (AE) and DI were evaluated. Kaplan–Meier survival curves and Cox proportional hazards regression were used to compare disease-free interval (DFI) and survival time (ST) among protocols. Results: The overall median DFI and ST were 291 days and 284 days, respectively. A lower proportion of dogs prescribed CARBO6 experienced AEs compared to other protocols (48.4% versus 60.8–75.8%; P = .001). DI was not associated with development of metastases or death. After adjustment for baseline characteristics and prognostic factors, none of the protocols provided a significant reduction in risk of development of metastases or death. Conclusions and Clinical Importance: Although choice of protocol did not result in significant differences in DFI or ST, the CARBO6 protocol resulted in a lower proportion of dogs experiencing AEs, which could be advantageous in maintaining high quality of life during treatment. DI was not a prognostic indicator in this study.
To determine associations between perioperative mortality after surgery for traumatic diaphragmatic hernia, medical records of 17 cats and 79 dogs that underwent diaphragmatic herniorrhaphy were reviewed. The combined perioperative survival rate was 81.3% (88.2% in cats and 79.8% in dogs). Data from acute and chronic cases was assessed separately. Of the acute cases (12 cats and 48 dogs), 10 cats (83.3%) and 38 dogs (79.2%) survived to discharge. Of the chronic cases (5 cats and 31 dogs), 5 cats (100%) and 25 dogs (80.6%) survived to discharge. The time between trauma and surgery, trauma and admission, and admission and surgery were not associated with survival. For cats and dogs, increased duration of anesthesia and surgical procedure were associated with increased mortality (P = 0.0013 and 0.004, respectively). Animals with concurrent soft tissue injuries had a 4.3 times greater odds of mortality than those without soft tissue injury (P = 0.01). Animals with concurrent soft tissue and orthopedic injuries had a 7.3 times greater odds of mortality than those without soft tissue and orthopedic injuries (P = 0.004). Animals that were oxygen dependent had a 5.0 times greater odds of mortality than those that were not (P = 0.02). No other variables were significantly associated with survival. For cats and dogs that underwent surgery for traumatic diaphragmatic hernia, increased anesthetic duration, increased duration of surgical procedure, concurrent soft tissue injuries, concurrent soft tissue and orthopedic injuries, and perioperative oxygen dependence were associated with increased mortality.