TY  - JOUR
A1  - Eichler, Katrin
A1  - Zangos, Stephan
A1  - Mack, Martin G.
A1  - Hammerstingl, Renate Maria
A1  - Gruber-Rouh, Tatjana
A1  - Gallus, Christof
A1  - Vogl, Thomas J.
T1  - First human study in treatment of unresectable liver metastases from colorectal cancer with irinotecan-loaded beads (DEBIRI)
T2  - International journal of oncology
N2  - 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.
KW  - intraarterial therapy
KW  - liver metastases
KW  - colorectal cancer
KW  - beads
Y1  - 2012
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/29899
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-298998
SN  - 1791-2423
SN  - 1019-6439
N1  - Copyright © 2012, Spandidos Publications. This is an open-access article licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License. The article may be redistributed, reproduced, and reused for non-commercial purposes, provided the original source is properly cited.
VL  - 41
IS  - 4
SP  - 1213
EP  - 1220
PB  - Spandidos Publ.
CY  - Athens
ER  -