Superselective TANDEM® Transarterial Chemoembolization May Provide Advantages for HCC
Interview with Dr. Anne Schmitz & Dr. Daniel Gnutzmann - University Hospital Heidelberg, Heidelberg, Germany
The use of Embozene TANDEM® (CeloNova BioSciences) 75 and 100 µm TACE appears to be safe and efficacious with a high rate of oncological success in patients with hepatocellular carcinoma (HCC) according to data presented at #GEST2014.
Investigators from Germany presented a study with 26 patients that showed a low rate of post embolization syndrome (PES) with standard intravenous medications. Researchers also found that HCC 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 Dr. Schmitz. “We are pleased with the outcome. The patients don’t have as much pain.”
Dr. Schmitz presented the latest prospective data with superselective TACE using TANDEM® 75μm and 100μm particles for the treatment of patients with HCC at #GEST2014. The primary endpoints for the study were time to progression (ttp) and overall survival (OS). The secondary endpoints were tumor control, PES and safety.
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.
Dr. Schmitz said there were 3 cases of occluded 2.8F microcatheter (Progreat Microcatheter, Terumo Interventional Systems) 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 but no clinical consequence, 1 case of acute liver failure seen in the blood panel but the patient was stabilized during the 3 day hospital stay, and a case involving gastrointestinal bleeding caused by cirrhosis of the liver with portal hypertension.
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 Dr. Gnutzmann 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.”
He and Dr. Schmitz 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.”
Dr. Schmitz 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 United States Oncozene Microspheres and already received the FDA 510k clearance.