Open Access

First human study in treatment of unresectable liver metastases from colorectal cancer with irinotecan-loaded beads (DEBIRI)

  • Authors:
    • K. Eichler
    • S. Zangos
    • M. G. Mack
    • R. Hammerstingl
    • T. Gruber-Rouh
    • C. Gallus
    • T. J. Vogl
  • View Affiliations

  • Published online on: July 25, 2012     https://doi.org/10.3892/ijo.2012.1572
  • Pages: 1213-1220
  • Copyright: © Eichler et al. This is an open access article distributed under the terms of Creative Commons Attribution License [CC BY_NC 3.0].

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Abstract

The objective of this pilot clinical study was to assess the safety, technical feasibility, pharmacokinetic (PK) profile and tumour response of DC Bead™ with irinotecan (DEBIRI™) delivered by intra-arterial embolisation for the treatment of metastatic colorectal cancer. Eleven patients with unresectable liver metastases from CRC, tumour burden <30% of liver volume, adequate haematological, liver and renal function, performance status of <2 were included in this study. Patients received up to 4 sessions of TACE with DEBIRI at 3-week intervals. Feasibility of the procedure, safety and tumour response were assessed after each cycle. PK was measured after the first cycle. Patients were followed up to 24 weeks. Only mild to moderate adverse events were observed. DEBIRI is a technically feasibile procedure; no technical complications were observed. Average Cmax for irinotecan and SN-38 was 194 ng/ml and 16.7 ng/ml, respectively, with average t½ of 4.6 h and 12.4 h following administration of DEBIRI. Best overall response during the study showed disease control in 9 patients (2 patients with partial response and 7 with stable disease, overall response rate of 18%). Our study shows that transarterial chemoembolisation with irinotecan-loaded DC beads (DEBIRI) is safe, technically feasible and effective with a good PK profile.
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October 2012
Volume 41 Issue 4

Print ISSN: 1019-6439
Online ISSN:1791-2423

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Spandidos Publications style
Eichler K, Zangos S, Mack MG, Hammerstingl R, Gruber-Rouh T, Gallus C and Vogl TJ: First human study in treatment of unresectable liver metastases from colorectal cancer with irinotecan-loaded beads (DEBIRI). Int J Oncol 41: 1213-1220, 2012.
APA
Eichler, K., Zangos, S., Mack, M.G., Hammerstingl, R., Gruber-Rouh, T., Gallus, C., & Vogl, T.J. (2012). First human study in treatment of unresectable liver metastases from colorectal cancer with irinotecan-loaded beads (DEBIRI). International Journal of Oncology, 41, 1213-1220. https://doi.org/10.3892/ijo.2012.1572
MLA
Eichler, K., Zangos, S., Mack, M. G., Hammerstingl, R., Gruber-Rouh, T., Gallus, C., Vogl, T. J."First human study in treatment of unresectable liver metastases from colorectal cancer with irinotecan-loaded beads (DEBIRI)". International Journal of Oncology 41.4 (2012): 1213-1220.
Chicago
Eichler, K., Zangos, S., Mack, M. G., Hammerstingl, R., Gruber-Rouh, T., Gallus, C., Vogl, T. J."First human study in treatment of unresectable liver metastases from colorectal cancer with irinotecan-loaded beads (DEBIRI)". International Journal of Oncology 41, no. 4 (2012): 1213-1220. https://doi.org/10.3892/ijo.2012.1572