Superselective TANDEM® Transarterial Chemoembolization May Provide Advantages for HCC

by Global Embolization
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Global Embolization Interviews Anne Schmitz.

The use of TANDEM® (CeloNova, BioScience, San Antonio, USA) 75 and 100 µm TACE appears to be safe and efficient with a high rate of oncological success in patients with hepatocellular carcinoma (HCCs)...

according to new data presented at GEST 2014 (Global Embolization Symposium and Technologies, May 1-4).  Investigators from Germany presented a study with 26 patients that showed a low rate of post embolization syndrome (PES) with standard intravenous medications.  The researchers also found that hepatocellular carcinomas (HCCs) on a border to the right/left liver lobe were a negative predictor.

“The idea is to go very deep into the tumor lesions with those new small particles (≤100µm) and that is why we are using this approach,” said Anne Schmitz, MD, who is with the University of Heidelberg, Heidelberg, Germany.  “We are pleased with the outcome.  The patients don’t have as much pain.”

Dr. Schmitz presented the latest data from the experiences with superselective TANDEM®-TACE in Heidelberg at GEST 2014.  She and her colleagues conducted a prospective evaluation of superselective TACE using TANDEM® 75μm and 100μm particles for the treatment of patients with HCCs.  The primary endpoints for the study were time to progression (ttp) and overall survival (OS).  The secondary endpoints were tumor control, PES and safety.

Dr. Schmitz said there were 3 cases of occluded 2.8F microcatheter (Progreat, Terumo, Japan) at the end of a TACE session in the beginning of the study, but the clinicians solved the problem by learning how to create the best solution with those particles.  She said there was 1 case of a septic necrosis encircling the embolized HCC tissue.  However, there was no clinical consequence.  There was 1 case of acute liver failure seen in the blood panel but the patient was stabilized during the 3 day hospital stay, and the third case involved gastrointestinal bleeding caused by cirrhosis of the liver with portal hypertension.
 
All the patients in this study were treated between May 2012 and September 2013.  The researchers evaluated 26 patients (21 male and 5 females).  The mean age of the patients was 58.2 years (range: 46-74 years). Each patient underwent TANDEM® TACE in obligative superselective technique until stasis of second-order branches was achieved.  Additional Embozene could be used until stasis was reached.  The mean number of lesions treated was 1.5.

The researchers found that all 26 patients based on MRI were able to achieve tumor control (100%) at 4 weeks post-procedure.  The study demonstrated that 14 patients had complete remission, 3 patients had stable disease, and 9 patients had a partial response, according to European Association for the Study of Liver (EASL) criteria.

“Our experiences are very good,” said Dr. Schmitz.  “We have a high rate of oncological success.   We have low rates of post embolization syndrome such as 35% after the first TACE.  Mostly the patients suffered from pain and nausea but could be treated with standard medications and they were discharged very soon. No one was suffering on permanent pain.”  Dr. Schmitz said the average hospital stay was 3 days due to German treatment guidelines.

Co-study investigator Daniel Gnutzmann MD, who works in the University Hospital Heidelberg, said there are many potential advantages with TACE with TANDEM® particles.  “The benefits with this approach are that it is very easy to use and improves quality of life of the patients.  It is good for patients as well.  They experience less discomfort.   Overall, it is very easy for the patients to undergo the procedure and there are very few side effects,” said Dr. Gnutzmann.

He and Dr. Schmidt said there should be multi-center studies to substantiate the findings in a larger number of patients.  “Our patient collective is not very big but it can provide first results for those new particles.  Our group is now testing even smaller particles for the use of the treatment of colorectal metastasis,” said Dr. Schmidt.

She said there is a significant need to have an embolic agent that can penetrate deeply into the tumor vasculature and deliver chemotherapy locally in a sustained manner.  TANDEM® particles are named in the US Oncozene® Microspheres and already received the FDA 510k clearance.

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