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Image-Guided Transarterial Chemoembolization With Drug-Eluting Beads Loaded with Doxorubicin (DEBDOX) for Unresectable Hepatic Metastases from Melanoma: Technique and Outcomes

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Abstract

Purpose

Hepatic metastasis from melanoma represents a therapeutic dilemma, with limited effective options for the 85% of cases deemed unresectable. Systemic agents confer toxicity and, along with traditional local hepatic arterial-directed therapies such as transarterial chemoembolization, have not led to a significant increase in survival. The aim of this study was to investigate the safety and dose-limiting toxicity of DEBDOX for the treatment of unresectable hepatic metastases from melanoma.

Methods

A multicenter (University of Louisville, Thomas Jefferson University, MD Anderson Cancer Center), prospective, non-controlled treatment trial (NCT01010984) of hepatic-directed therapy with DEBDOX for the treatment of melanoma liver metastasis was reviewed. Primary endpoints were response rates by modified response evaluation criteria in solid tumors, hepatic progression-free survival (PFS), and overall survival (OS).

Results

Twenty patients received a total of 61 DEBDOX treatments from January 2010 to March 2013. The median hepatic tumor burden was 40% (range 20–55), 18 patients (90%) had bilobar disease, and 13 patients (65%) had concomitant extrahepatic disease. At median assessment of 2.5 months, 11 patients (55%) exhibited a tumor response and 16 (80%) exhibited disease control. Median follow-up was 5 months (range 1.1–34.3 months). Median hepatic PFS was 3 months (95% CI 1.4, 3.4), and OS was 5 months (95% CI 3.3, 10.5).

Conclusions

Directed arterial therapy with DEBDOX is effective in managing unresectable liver-dominant metastasis from melanoma and should be considered a therapeutic option in the multidisciplinary treatment of this disease. Concurrent systemic therapy is merited given the high rate of extrahepatic progression.

Clinical trial

NCT01010984.

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Funding

Partial research support for this Phase 1 trial came from unrestricted funding from Biocompatibles, UK. LC Bead loaded with DEBDOX is not an approved device in the USA. (Only LC Bead alone is approved for hypervascular hepatic tumors).

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Authors

Corresponding author

Correspondence to Robert C. G. Martin II.

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Conflict of interest

Senior author: Consultant for Biocompatibles, a subsidiary of BTG International, makers of LC Beads. On behalf of all authors, the corresponding author states that there is no other conflict of interest.

Ethical Approval

“All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.”

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Rostas, J., Tam, A., Sato, T. et al. Image-Guided Transarterial Chemoembolization With Drug-Eluting Beads Loaded with Doxorubicin (DEBDOX) for Unresectable Hepatic Metastases from Melanoma: Technique and Outcomes. Cardiovasc Intervent Radiol 40, 1392–1400 (2017). https://doi.org/10.1007/s00270-017-1651-z

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  • DOI: https://doi.org/10.1007/s00270-017-1651-z

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