Transarterial Chemoembolization with Drug-Eluting Beads
Loaded with Doxorubicin for the Treatment of Metastatic
Breast Cancer to the Liver: a pilot study

Transarterial chemoembolization and chemoperfusion are wellknown regional
therapies that have been used in patients with hepatocellular carcinoma and
liver metastases from colorectal carcinoma. Studies on the use of these
strategies in patients with breast cancer are scarce, although these strategies
have the ability to deliver highdose chemotherapy directly to the liver, with
minimal systemic chemotherapy effects. In our department, we have limited
experience with the interaarterial threatment of patient with liver metastases
of breastcancer with mitomycin-C. The success rate of this treatment is
limited.
Drug eluting bead TACE is a novel drug delivery system that combines the local
embolization of vasculature with slow release of chemotherapy into tissue.
Beads are composed of biocompatible polymers such as polyvinyl alcohol ( PVA).
They occlude vasculature , causing embolization, and the chemotherapy is
delivered locally The aim of the present study is to evaluate the efficacy of
hepatic arterial doxorubicin therapy in MBC.

To study the safety, feasibility ,t oxicity , tolerance and respons rate
(RECIST-criteria) of the intra-arterial treatment with Doxirubicin -loaded
Beads (DEBDOX) in patients with liver dominant metastasized breast cancer.

A prospective, non-controlled single-institution pilot study.

The treatment is hepatic intra-arterial therapy with doxorubicin loaded DC
Bead .

DC Bead® are hydrogel-embolic, drug-eluting beads that are precisely calibrated
and made of polyvinyl alcohol, are biocompatible, hydrophilic and
non-resorbable. During a 2-hour loading period 150 mg of doxorubicin will be
loaded on DC-beads in two bead vials .

Angiography procedure is performed ( after placement of an epidural catheter
for pain relief) by the interventional radiologist, during which selective
celiac and superior mesenteric arteriography will be performed to evaluate the
hepatic arterial anatomy. For tumors near the periphery of the liver,
evaluation of potential extrahepatic supply to the tumors, such as the inferior
phrenic, gastroepiploic, and internal mammary arteries, will be done.

The next step is to limit any type of extrahepatic perfusion of the treatment.
The most common branches that will lead to extrahepatic disposition of
treatment are the right gastric and gastroduodenal arteries, which are
controlled either prior to infusion with coil embolization or with distal
catheter placement.

DEBDOX will be mixed with non-ionic contrast (approximately 50/50 dilution)
prior to injection.

For unilobar disease, a treatment cycle consists of two dosing schedules of
100-150 mg DEBDOX each .

For diffuse disease, four dosing schedules of 100-150 mg DEBDOX ( alternating
in both hepatic lobes, first into either the right or left artery, depending
on the bulk of disease) is performed, with a 2- to 4-week interval, depending
on toxicity.

A repeat CT-scan will be performed every 3 months from the initial first
treatment cycle to evaluate response as well as planned retreatment .

Risk of CT: hypersensitivity to iodinated contrast medium, contrastnefropathy
in patient with increased risk. These risk are equal to the risk of any other
patient undergoing CT-scans

Risk of angiograpy: bleeding at the puncture site ( 0-5%), development of
pseudoaneurysm ( very rare), dissection ( very rare).

Risk of embolization: postprocedural pain ( often), postembolization syndrome
with liver toxicity ( raised enzymes, frequent) and liver failure ( defined as
the inability of the liver to perform its normal synthetic and metabolic
function as part of normal physiology, very rare)