European Multicenter Study on Degradable Starch Microsphere TACE: The Digestible Way to Conquer HCC in Patients with High Tumor Burden

Abstract

To evaluate the safety and efficacy of transarterial chemoembolization with degradable starch microspheres (DSM-TACE) for the treatment of hepatocellular carcinoma (HCC) with a high tumor burden ineligible for or failing other palliative therapies, 121 patients from three European centers were included. Kaplan–Meier analysis was used for median overall survival (OS) and time to progression (TTP, mRECIST criteria) in months with a 95% confidence interval (95% CI). Uni- (UVA) and multivariate (MVA) analyses were performed using the Cox Proportional Hazard Model. The median OS of the study cohort was 15.5 (13.3–18.7) months. The UVA identified HCC lesions ≤10 cm, unilobar involvement, lower Child–Pugh class and Barcelona Clinic Liver Cancer (BCLC) stage, absence of vascular invasion, and extrahepatic metastases as factors for prolonged survival. MVA confirmed lesions of ≤10 cm and unilobar disease as independent OS factors. Median TTP was 9.5 (7.6–10.3) months. The best response was achieved after a median of 3 (range: 1–6) treatments with CR/PR/SD/PD in 13.5%/44.5%/25.2%/16.8%, respectively. DSM-TACE was well tolerated with no major clinical adverse events and only limited major laboratory events. Preserved liver function was observed after repetitive DSM-TACE treatments. Repetitive DSM-TACE is a safe, well-tolerated and effective treatment option for HCC patients with high tumor burden ineligible or failing other palliative therapies.

Emerging Polymer Materials in Trackable Endovascular Embolization and Cell Delivery: From Hype to Hope

“…DSMs have been recommended for use in patients who need multiple chemotherapeutic treatments by cTACE [ 98 ]. This material also has been used in patients with a reduced hepatic function who cannot endure more damage to the surrounding hepatic tissue induced by ischemic necrosis [ 99 ].…”

Chemoembolization for Hepatocellular Carcinoma: A Critical Review of The 2021 CIRSE Recommendations with Presentation of A Technique for A Degradable Starch Microsphere - Chemoembolization

“…Ludwig et al [2] published the retrospective results of a multi-center study (three clinics in Europe). The patients were treated between 2009 and 2018.…”

“…This leads to slow healing and painful defects in the mucous membrane of the duodenal wall. Ludwig et al, [2] concluded that DSM-TACE is a good option for patients with HCC for whom there is no other possible treatment. However, Lipiodol was not used as a marker substance in the study and the aim was complete stasis in the treated vascular bed.…”

“…The paper also neglects to mention which method should be used for which type of tumor and in which clinical circumstances. Another publication from 2021 [2] presents the results of a European study in which degradable starch microspheres (DSM) were used as an embolic agent. However, no Lipiodol is used as a marker substance in this technique.…”

TACE for HCC: A critical review of the 2021 CIRSE recommendations with presentation of a technique for a degradable starch microsphere—TACE

“…Furthermore, there are no clear recommendations for which substances to use or in which order. Another publication from 2021 2 presents the results of a European study in which degradable starch microspheres (DSM) were used as an embolic agent. However, no Lipiodol® is used as a marker substance in this technique and there were no control group.…”