New data demonstrate clinical experience with LifePearl microspheres in over 300 hepatocellular carcinoma patients

Leuven, Belgium. - June 19, 2018 Key publication with real life clinical experience in over 300 patients with Hepatocellular Carcinoma (HCC) treated with Drug-eluting microspheres transarterial chemoembolisation (DEM-TACE) LifePearl® microspheres

This peer reviewed paper, published in reputed Journal of Vascular Interventional Radiology (JVIR)¹ by lead author Dr. Filipe Gomes Veloso, from hospital Curry Cabral, Lisbon, Portugal, includes one of the largest patient population treated with DEM-TACE in HCC. The purpose of the study was to evaluate the efficacy and safety of DEM-TACE with the use of precisely calibrated microspheres LifePearl in the treatment of HCC in 302 patients during a 20-month period of time.

Median follow-up time was 11.9 months. One-month follow-up CT revealed complete response in 179 patients (63.2%), partial response in 63 (22.3%), stable disease in 16 (5.7%), and progressive disease in 25(8.8%). The most frequent complications were post-embolization syndrome in 18 patients (6%), liver abscess in 5 (1.7%), and puncture site hematoma in 3 (1%). Biochemical toxicities occurred in 57 patients (11.6%). Survival analysis at 12 months showed a progression free survival rate of 65.9% and overall survival rate of 93.5%. Patients who received transplants showed a 57.7% rate of complete pathologic response. Dr. Veloso concluded that "Chemoembolization with PEG embolic agents for HCC is safe and effective, achieving an objective response rate of 85.5%."¹

Dra Élia Coimbra, head of Interventional Radiology Unit said: "Chemoembolization of hepatocellular carcinoma with drug eluting embolics plays a crucial role in both our liver transplant candidates, and intermediate stage patients, according to BCLC classification. Our goal is to improve patient outcomes continuously, which is why we are dedicating more resources to research at our Hospital."

LifePearl microspheres are used in the treatment of primary and secondary liver cancer and comprises a range of microspheres that are biocompatible, hydrophilic, precisely calibrated and capable of loading and releasing chemotherapeutic agents in a controlled manner. This supports the wider use of TACE in reproducible and standardised manner as well as providing physicians with another option to treat patients in the early stage of BCLC staging.

Since its launch in 2015, LifePearl microspheres have been used in approximately 8,000 transarterial chemoembolisation (TACE) procedures in Europe, Middle East and Africa. LifePearl microspheres have now seven publications in various scientific journals and have been the subject of multiple clinical trials and presentations in interventional radiology congresses. The results in all studies are consistent and promising. ^2-5

1. Filipe Veloso Gomes et al - Chemoembolization of Hepatocellular Carcinoma with Drug-Eluting Polyethylene Glycol Embolic Agents: Single-Center Retrospective Analysis in 302 Patients; J Vasc Interv Radiol 2018; ▪:1-9
2. Giammaria Fiorentini et al Polyethylene glycol microspheres loaded with irinotecan for arterially directed embolic therapy of metastatic liver cancer World J Gastrointest Oncol 2017 September 15; 9(9): 379-384
3. Camillo Aliberti et al - Chemoembolization Adopting Polyethylene Glycol Drug-Eluting Embolics Loaded With Doxorubicin for the Treatment of Hepatocellular Carcinoma AJR 2017; 209:1-5
4. Camillo Aliberti et al - Chemoembolization with Drug-eluting Microspheres Loaded with Doxorubicin for the Treatment of Cholangiocarcinoma; ANTICANCER RESEARCH 37: 1859-1863 (2017)
5. Camillo Aliberti et al - Hepatic Arterial Infusion of Polyethylene Glycol Drug-eluting Beads for Primary and Metastatic Liver Cancer Therapy; ANTICANCER RESEARCH 36: 3515-3522 (2016)