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

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De Ridder, T.R.  et al. (2020) Randomized controlled clinical study evaluating the efficacy and safety of intratumoral treatment of canine mast cell tumors with tigilanol tiglate (EBC‐46), Journal of Veterinary Internal Medicine. https://doi.org/10.1111/jvim.15806

Summary

This paper reports on a randomised controlled trial evaluating the efficacy and safety of a new treatment for mast cell tumours. When a completely new treatment becomes available, we need to carefully assess the evidence that is presented so that we are able to discuss the treatment options with the owner as part of the process of gaining informed consent.

It has been suggested that in assessing a new treatment we should look for evidence in four specific areas covered by the acronym STEP and compare these to current treatment options:

Safety – what are the side effects of the treatment? Remember that rare but serious, or long term, side effects may not be documented when a product is newly introduced.

Tolerability – this relates to minor side effects that may be experienced by the animal during treatment and can be assessed by looking at withdrawal rates during the trial.

Efficacy – is the product effective and how does it compare with other available treatments.

Price -which should take into account both direct and indirect costs of the treatment.

A checklist for Controlled trials is available.

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Further reading

These articles may useful when you are considering treatment options for mast cell tumours

European Medicines Agency.  STELFONTA (tigilanol tiglate): summary of product characteristics.  [online] Available at https://www.ema.europa.eu/en/documents/product-information/stelfonta-epar-product-information_en.pdf [Accessed 6 October 2020]

Abrams, B.E. (2020) Variability in tumor margin reporting for soft tissue sarcoma and cutaneous mast cell tumors in dogs: A systematic review. Veterinary Surgery, 50 (2), pp 259-272. https://doi.org/10.1111/vsu.13539

Blackwood, L. et al (2012) European consensus document on mast cell tumours in dogs and cats. Veterinary and comparative oncology, 10 (3), pp .e1-e29. https://doi.org/10.1111/j.1476-5829.2012.00341.x

Brown, G.K et al. (2022) Treatment of multiple synchronous canine mast cell tumours using intratumoural tigilanol tiglate. Frontiers in Veterinary Science, 26, no. 1003165 https://doi.org/10.3389/fvets.2022.1003165

Brown, G.K. et al (2021) Intratumoural treatment of 18 cytologically diagnosed canine high-grade mast cell tumours with tigilanol tiglate. Frontiers in Veterinary Science, 8, no. 966. https://doi.org/10.3389/fvets.2021.675804

Jones, P.D. et al (2020) Recurrence‐free interval 12 months after local treatment of mast cell tumors in dogs using intratumoral injection of tigilanol tiglate. Journal of Veterinary Internal Medicine, 35 (1), pp. 451-455. https://doi.org/10.1111/jvim.16018

Kiupel, M. and Camus, M. (2019) Diagnosis and Prognosis of Canine Cutaneous Mast Cell Tumors. The Veterinary Clinics of North America: Small Animal Practice, 49 (5), pp.819-836. https://doi.org/10.1016/j.cvsm.2019.04.002

Miller, J. et al (2019) Dose characterization of the investigational anticancer drug tigilanol tiglate (EBC-46) in the local treatment of canine mast cell tumors Frontiers in Veterinary Science, 6, no.106. https://doi.org/10.3389/fvets.2019.00106

Oliveira, T.M. et al (2020) Canine and feline cutaneous mast cell tumour: a comprehensive review of treatments and outcomes, Topics in Companion Animal Medicine, 41 no.100472. https://doi.org/10.1016/j.tcam.2020.100472

Reddell, P. et al (2021) Wound formation, wound size, and progression of wound healing after intratumoral treatment of mast cell tumors in dogs with tigilanol tiglate,  Journal of Veterinary Internal Medicine, 35 (1), pp.430-441. https://doi.org/10.1111/jvim.16009

Shaw, T., Kudnig, S.T., and Firestone, S.M. (2018) Diagnostic accuracy of pre‐treatment biopsy for grading cutaneous mast cell tumours in dogs. Veterinary and comparative oncology, 16 (2), pp. 214– 219. https://doi.org/10.1111/vco.12346