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J Vasc Interv Radiol. 2018 Dec;29(12):1646-1653.e5. doi: 10.1016/j.jvir.2018.08.010. Epub 2018 Oct 15.

Irinotecan-Eluting 75-150-μm Embolics Lobar Chemoembolization in Patients with Colorectal Cancer Liver Metastases: A Prospective Single-Center Phase I Study.

Author information

1
Department of Radiology and Biomedical Imaging, Yale University School of Medicine, 300 Cedar Street, The Anlyan Center, N312A, New Haven, CT 06520.
2
Department of Radiology and Biomedical Imaging, Yale University School of Medicine, 300 Cedar Street, The Anlyan Center, N312A, New Haven, CT 06520. Electronic address: julius.chapiro@yale.edu.
3
Division of Vascular and Interventional Radiology, Russell H. Morgan Department of Radiology and Radiological Science, Johns Hopkins Hospital, Baltimore, Maryland.

Abstract

PURPOSE:

The primary end point of this trial was to determine the feasibility and safety of transarterial chemoembolization with the use of 75-150-μm drug-eluting embolics loaded with irinotecan (DEE-IRI) for the treatment of metastatic colorectal cancer (CRC) refractory to systemic chemotherapy.

MATERIALS AND METHODS:

Fourteen patients (mean age 57.9 years) with liver-dominant metastatic disease (14.3% unilobar, 85.7% bilobar), who had failed at least 1 line of chemotherapy, were enrolled and received up to 4 (mean 2.3) cycles of DEE-IRI lobar transarterial chemoembolization. Technical complications and adverse events were recorded, and response was assessed by means of imaging-based criteria. Levels of irinotecan and angiogenesis biomarkers in the serum were measured at multiple time points.

RESULTS:

Thirty-two DEE-IRI transarterial chemoembolizations were successfully performed, and the full dose (100 mg) was delivered in all cases. The only grade 3-4 toxicity was abdominal pain (29%). One patient had objective response according to the Response Evaluation Criteria in Solid Tumors and World Health Organization, and 3 patients had objective response according to the European Association for the Study of the Liver. The median overall survival was 18.14 months, and the 1-year survival was 65%. The average plasma Cmax of the active metabolite was 41.5 ± 26.1 ng/mL, with average Tmax of 1.3 ± 0.5 hours. The treatment significantly reduced levels of vascular endothelial growth factor receptor 1 (VEGFR1) at 24 hours.

CONCLUSIONS:

Lobar transarterial chemoembolization with the use of DEE-IRI is a technically feasible and well tolerated palliative treatment for patients with refractory liver-predominant CRC metastatic disease and has acceptable pharmacokinetics. VEGFR1 is a potential biomarker for predicting treatment efficacy and risk of adverse events.

PMID:
30337148
DOI:
10.1016/j.jvir.2018.08.010
[Indexed for MEDLINE]

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