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Publication Detail
Phase 0 study of vandetanib-eluting radiopaque embolics as a pre-operative embolization treatment in patients with resectable liver malignancies.
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Article
  • Authors:
    Beaton L, Tregidgo HF, Znati SA, Forsyth S, Counsell N, Clarkson MJ, Bandula S, Chouhan M, Lowe HL, Thin MZ, Hague J, Sharma D, Pollok J-M, Davidson BR, Raja J, Munneke G, Stuckey DJ, Bascal ZA, Wilde PE, Cooper S, Ryan S, Czuczman P, Boucher E, Hartley JA, Atkinson D, Lewis AL, Jansen M, Meyer T, Sharma RA
  • Publisher:
    Elsevier
  • Publication date:
    05/05/2022
  • Pagination:
    S1051, 0443(22)00834
  • Journal:
    Journal of Vascular and Interventional Radiology
  • Medium:
    Print-Electronic
  • Status:
    Published
  • Country:
    United States
  • Print ISSN:
    1051-0443
  • PII:
    S1051-0443(22)00834-X
  • Language:
    English
Abstract
PURPOSE: To assess the safety and tolerability of a vandetanib-eluting radiopaque embolic (BTG-002814) for transarterial chemo-embolization in patients with resectable liver malignancies. METHODS: The VEROnA clinical trial was a first-in-human, phase 0, single-arm, window-of-opportunity study. Eligible patients were aged ≥18 years, had resectable hepatocellular carcinoma (HCC)(Child-Pugh A) or colorectal liver metastases (mCRC). Patients received 1mL of BTG-002814 transarterially (containing 100mg vandetanib) 7-21 days prior to surgery. Primary objectives were to establish the safety and tolerability of BTG-002814, and to determine concentrations of vandetanib and the N-desmethyl metabolite in plasma and resected liver post-treatment. Biomarker studies included circulating pro-angiogenic factors, perfusion computed tomography and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI). RESULTS: Eight patients were enrolled: two with HCC, and six with mCRC. There was one Grade 3 adverse event (AE) pre-surgery and 18 post-surgery; six AEs were deemed BTG-002814 related. Surgical resection was not delayed. Vandetanib was present in the plasma of all patients 12 days post-treatment with a mean maximum concentration (Cmax) of 24.3 ng/mL (SD 13.94) and present in resected liver tissue up to 32 days post-treatment (441-404,000 ng/g). Median tumor necrosis was 92.5% (range 5-100%). There were no significant changes in perfusion imaging parameters post-TACE. CONCLUSION: BTG-002814 has an acceptable safety profile in patients pre-surgery. Presence of vandetanib in tumor specimens up to 32 days post-treatment suggests sustained anticancer activity; low vandetanib plasma levels suggest minimal release into the systemic circulation. Further evaluation of this TACE combination is warranted in dose-finding and efficacy studies.
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Department of Imaging
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Dept of Med Phys & Biomedical Eng
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CRUK Cancer Trials Centre
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Department of Surgical Biotechnology
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Research Department of Oncology
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Research Department of Pathology
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Research Department of Oncology
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Div of Surgery & Interventional Sci
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Department of Imaging
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Dept of Med Phys & Biomedical Eng
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