Trans-arterial chemoembolization of metastatic colorectal carcinoma to the liver adopting DC Bead®, drug-eluting bead loaded with irinotecan: Results of a phase II clinical study

Unit of Oncological Interventional Radiology, IOV (IRCCS), Padova, Italy.
Anticancer research (Impact Factor: 1.83). 12/2011; 31(12):4581-7.
Source: PubMed


Trans-arterial chemoembolization (TACE) is a promising locoregional therapy for the treatment of primary hepatic tumors and liver metastases. The aim of the study was to define the activity and outcome of using DC Bead, drug-eluting bead, a spherical embolic device capable of being loaded with irinotecan.
We conducted a double institutional, single arm, phase II clinical study to evaluate TACE adopting this device in 82 patients presenting with metastatic colorectal carcinoma to the liver after failing chemotherapy. The primary endpoints were tumor shrinkage, safety, feasibility, compliance, and overall survival. RECIST criteria were used to assess responses. Quality of life (QoL) was addressed using Edmonton SAS improvement scale.
Out of 103 patients considered, 82 were enrolled and underwent a total of 185 treatments of TACE. The median number of TACE was 2.2 (1-4). A post-embolization syndrome was frequently observed. Adverse observed effects were: right upper quadrant pain (40%), fever (80%), nausea (27%) and increased transaminases (70%). The median follow-up was 29 months. Within one month after treatment, each patient received a computed tomograpic scan. It showed reduction of metastatic contrast enhancement in all patients. Responses were 78% at 3 months. After the first treatment, 75 out 82 patients declared an improvement of their well being lasting more than 18 weeks. The median duration of response was 6 (range 3-10) months; the median follow up was 29 (range 7-48) months. The median survival was 25 (range 6-34) months, with progression free survival at 8 (range 4-16) months.
We suggest that TACE adopting DC Bead®, drug-eluting bead loaded with irinotecan could be proposed as palliative therapy for unresectable and chemotherapy resistant liver metastases from CRC.

1 Follower
20 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Liver metastases are found at diagnosis in up to 25% of patients with colorectal cancer (CRC) and they appear during the first 3 years following diagnosis in another 40–50% [1]. Although liver resection is currently the only therapy producing long-term cure, at diagnosis 80% of patients are not considered to be candidates for resection because of the size, location, and extent of their disease. Radiofrequency ablation has been proposed as an alternative to surgery, but at present its effectiveness in terms of local disease control is still inferior to that of liver resection [2]. Transhepatic arterial chemoembolization (TACE) and transarterial 90Y radioembolization (TARE) are more recent techniques that have been evaluated in patients with locally advanced disease; however only preliminary data are available [3,4] and larger studies are needed to better evaluate these treatments.
    No preview · Chapter · Jan 2012
  • [Show abstract] [Hide abstract]
    ABSTRACT: Lipiodol-based transarterial chemoembolization (TACE) has been performed for over 3 decades for the treatment of solid tumors and describes the infusion of chemotherapeutic agents followed by embolization with particles. TACE is an effective treatment for inoperable hepatic tumors, especially hypervascular tumors such as hepatocellular carcinoma. Recently, drug eluting beads (DEBs), in which a uniform embolic material is loaded with a drug and delivered in a single image-guided step, have been developed to reduce the variability in a TACE procedure. DEB-TACE results in localization of drug to targeted tumors while minimizing systemic exposure to chemotherapeutics. Once localized in the tissue, drug is eluted from the DEB in a controlled manner and penetrates hundreds of microns of tissue from the DEB surface. Necrosis is evident surrounding a DEB in tissue days to months after therapy; however, the contribution of drug and ischemia is currently unknown. Future advances in DEB technology may include image-ability, DEB size tailored to tumor anatomy and drug combinations.
    No preview · Article · Jan 2012 · Journal of Controlled Release
  • [Show abstract] [Hide abstract]
    ABSTRACT: Drug-eluting beads (DEBs) may become a standard of care in the treatment of unresectable liver cancers. DEBs have a significant advantage by offering simultaneous embolisation, and sustained release of antineoplastic agents in a controlled manner, resulting in a localisation of the drug in the targeted tumour, while minimising its systemic exposure. This article reviews current treatment options for liver cancer and concentrates on the benefits of DEBs for patients with unresectable liver cancer. Preclinical and clinical studies suggest smaller microspheres and extended release characteristics as key properties that will enable DEB device technologies to become a standard of care for unresectable liver cancer. A new, tightly size-calibrated DEB ≤100 μm, Embozene TANDEM™, was designed to meet these requirements.
    No preview · Article · Jul 2012 · European Oncology and Haematology
Show more