Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate (EBC-46).

OBJECTIVE: To evaluate the efficacy and safety of tigilanol tiglate (TT) for local intratumoral treatment of mast cell tumors (MCTs) in dogs. METHODS: A randomized controlled clinical study in 2 phases involving 123 dogs with cytologically diagnosed MCT. Phase 1 compared 81 TT-treated dogs with 42 control dogs; phase 2 allowed TT treatment of control dogs and retreatment of dogs that failed to achieve tumor resolution after TT treatment in phase 1. Tigilanol tiglate (1 mg/mL) was injected intratumorally with dose based on tumor volume. Concomitant medications were used to minimize potential for MCT degranulation. Modified response evaluation criteria in solid tumors were used to evaluate treatment response at 28 and 84 days. Adverse events and quality of life were also assessed. RESULTS: A single TT treatment resulted in 75% complete response (CR) (95% confidence interval [CI] = 61-86) by 28 days, with no recurrence in 93% (95% CI = 82-97) of dogs by 84 days. Eight TT-treated dogs that did not achieve CR in phase 1 achieved CR after retreatment, increasing the overall CR to 88% (95% CI = 77-93). Control dogs had 5% CR (95% CI = 1-17) at 28 days. Wound formation after tumor slough and wound size relative to tumor volume were strongly associated with efficacy. Adverse events typically were low grade, transient, and directly associated with TT's mode of action. CONCLUSIONS: Tigilanol tiglate is efficacious and well tolerated, providing a new option for the local treatment of MCTs in dogs.

Medical Students Immersed in a Hyper-Realistic Surgical Training Environment Leads to Improved Measures of Emotional Resiliency by Both Hardiness and Emotional Intelligence Evaluation.

BACKGROUND: Burnout is being experienced by medical students, residents, and practicing physicians at significant rates. Higher levels of Hardiness and Emotional Intelligence may protect individuals against burnout symptoms. Previous studies have shown both Hardiness and Emotional IntelIigence protect against detrimental effects of stress and can be adapted through training; however, there is limited research on how training programs affect both simultaneously. Therefore, the objective of this study was to define the association of Hardiness and Emotional Intelligence and their potential improvement through hyper realistic immersion simulation training in military medical students. METHODS: Participants in this study consisted of 68 second year medical students representing five medical schools who were concurrently enrolled in the United States military scholarship program. During a six day hyper-realistic surgical simulation training course, students rotated through different roles of a medical team and responded to several mass-casualty scenarios. Hardiness and Emotional Intelligence were assessed using the Hardiness Resilience Gauge (HRG) and the Emotional Quotient Inventory (EQ-I 2.0) respectively, at two time points: on arrival (pre-event) and after completion of the course (post-event). RESULTS: Hardiness and Emotional Intelligence scores and sub scores consistently improved from pre-event to post-event assessments. No difference in training benefit was observed between genders but differences were observed by age where age was more often associated with Emotional Intelligence. In addition, factor analysis indicated that the HRG and EQ-I 2.0 assessment tools measured predominately different traits although they share some commonalities in some components. CONCLUSION: This study indicates that Hardiness and Emotional Intelligence scores can be improved through immersion training in military medical students. Results from this study support the use of training course interventions and prompt the need for long term evaluation of improvement strategies on mitigating burnout symptoms.