Evidence map›Paper›PMID 32542733›Full record

ArticleJournal of veterinary internal medicine2021

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

Thomas R De Ridder, Justine E Campbell, Cheryl Burke-Schwarz, David Clegg, Emily L Elliot, Samuel Geller, Wendy Kozak, Stephen T Pittenger, Jennifer B Pruitt, Jocelyn Riehl and 8 more

Open access · goldAbstract readRandomized Controlled Trial, Veterinary
In one paragraph

Article in Journal of veterinary internal medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed
6.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 65 citations in OpenAlex.

  1. Article
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  6. Review
  7. Tigliane Diterpenoids.Progress in the chemistry of organic natural products · 2024
    Review
  8. Anal sac mast cell tumor in a dog.The Canadian veterinary journal = La revue veterinaire canadienne · 2023
    Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 12 institutions in 3 countries.

Thomas R De RidderQBiotics Group Limited, Yungaburra, Queensland, Australia.ORCID https://orcid.org/0000-0003-2628-5684
Justine E CampbellQBiotics Group Limited, Yungaburra, Queensland, Australia.
Cheryl Burke-SchwarzParadise Animal Hospital, Catonsville, Maryland, USA.
David CleggLiverpool Animal Health Clinic, Liverpool, New York, USA.
Emily L ElliotChippens Hill Veterinary Hospital, Bristol, Connecticut, USA.
Samuel GellerQuakertown Veterinary Clinic, Quakertown, Pennsylvania, USA.
Wendy KozakFranklin Lakes Animal Hospital, Franklin Lakes, New Jersey, USA.
Stephen T PittengerMemorial - 610 Hospital for Animals, Houston, Texas, USA.
Jennifer B PruittAirport Road Animal Clinic, Ocala, Florida, USA.
Jocelyn RiehlParadise Animal Hospital, Catonsville, Maryland, USA.
Julie WhiteAnimal Hospital of Seminole, Seminole, Florida, USA.
Melissa L WiestBradford Park Veterinary Hospital, Springfield, Missouri, USA.
Chad M JohannesCollege of Veterinary Medicine, Iowa State University, Ames, Iowa, USA.
John MortonJemora Consulting, Geelong, Victoria, Australia.
Pamela D JonesQBiotics Group Limited, Yungaburra, Queensland, Australia.
Peter F SchmidtQBiotics Group Limited, Yungaburra, Queensland, Australia.
Victoria GordonQBiotics Group Limited, Yungaburra, Queensland, Australia.
Paul ReddellQBiotics Group Limited, Yungaburra, Queensland, Australia.
NovaBiotics (United Kingdom) · GBParadise Valley Hospital · USBristol Hospital · USIowa State University · USLiverpool Community Health NHS Trust · GBMatthew Larson Foundation · USMemorial Hermann · USNemours Children’s Clinic · USReformed Theological College · AUSignPath Pharma (United States) · USSouth Seminole Hospital · USSpringfield Hospital · GB

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863QBiotics Group Limited
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of tigilanol tiglate (TT) for local intratumoral treatment of mast cell tumors (MCTs) in dogs.

methodsA 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.

resultsA 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.

conclusionsTigilanol tiglate is efficacious and well tolerated, providing a new option for the local treatment of MCTs in dogs.

Indexed as

DiterpenesDog DiseasesNeoplasmsSkin NeoplasmsAnimalsDogsQuality of LifeDiterpenesEBC-46cutaneousditerpene esterdoglocal treatmentMCTsubcutaneous

Identifiers

PMID32542733
PMCPMC7848366
OpenAlexW3035062120

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.