# Retrospective Italian Registry on DSM-TACE: Experience Beyond Current Recommendations

## TL;DR

This study shows that DSM-TACE with EmboCept® is a safe and effective treatment for liver cancer, with better results when using a superselective approach.

## Contribution

The study provides real-world evidence that a superselective DSM-TACE approach improves tumor response compared to a lobar strategy.

## Key findings

- DSM-TACE with EmboCept® showed high tumor response and disease control rates in early follow-up.
- Superselective DSM-TACE achieved significantly better tumor response than lobar strategy at intermediate follow-up.
- No major complications or procedure-related deaths were observed, confirming the safety of DSM-TACE.

## Abstract

DSM-TACE with EmboCept® was safe and effective in a large Italian multicenter cohort of patients with early- to advanced-stage HCC, showing good tolerability with no major complications. Overall tumor response and disease control were high at early follow-up and gradually declined over time. Importantly, a superselective DSM-TACE approach achieved significantly better tumor response than a lobar strategy at intermediate follow-up, supporting DSM-TACE as a liver-sparing and flexible treatment option, particularly for localized disease.

Background: The role of transarterial chemoembolization (TACE) in hepatocellular carcinoma (HCC) management has evolved over recent years. Although it appears that the overall number of procedures is declining, international guidelines now endorse TACE beyond the Barcelona Clinic Liver Cancer (BCLC) intermediate stage, and multiple TACE platforms allow patient-tailored treatments. In this context, degradable starch microspheres TACE (DSM-TACE) may be valuable when the goal is to preserve liver function and spare healthy parenchyma. This study reports multicenter retrospective Italian data to assess the efficacy and safety of DSM-TACE with EmboCept® in patients with early-to advanced-stage HCC, and to evaluate whether procedural selectivity (superselective vs. lobar) influences outcomes. Methods: This retrospective multicenter study included 201 patients initially; after applying exclusion criteria, 187 patients (334 HCC nodules) treated across eight centers (2014–2024) were analyzed. Treatment indications were discussed in multidisciplinary tumor boards in all centers. Superselective DSM-TACE was performed in 48 patients (66 nodules, 19.8%), while 139 patients (268 nodules, 80.2%) underwent a lobar approach. Repeated sessions were performed on demand and recorded for lobar treatments. Tumor response was assessed using mRECIST criteria at 1, 3–6, 6–9, and 9–12 months; adverse events were classified according to the Common Terminology Criteria for Adverse Events (CTCAE). efficacy and safety outcomes were compared according to the DSM-TACE approach. Results: In terms of safety, analysis confirmed the overall good tolerability of DSM-TACE, with no grade ≥ 3 adverse events and no major complications or procedure-related deaths. No significant differences were observed in post-embolization syndrome (PES) rates between groups. With regard to efficacy, for the entire cohort, the overall response rate (ORR) was 70% at 1 month, 31.6% at 3–6 months, 20.5% at 6–9 months, and 13.5% at 9–12 months, while the disease control rate (DCR) was 91.4% at 1 month, 69% at 3–6 months, 38.6% at 6–9 months, and 27% at 9–12 months. At intermediate follow-up, superselective DSM-TACE achieved higher ORR than lobar treatment at 3–6 months (53.8% vs. 26.4%; p = 0.009) and 6–9 months (43.8% vs. 15.3%; p = 0.009). Per-nodule analysis confirmed this advantage at 3–6 months (ORR = 66.7% vs. 31.3%; p = 0.0008). Conclusions: DSM-TACE with EmboCept® provides favorable tumor control and a good safety profile in routine clinical practice. A superselective approach is associated with improved response at intermediate follow-up compared with lobar strategy, supporting DSM-TACE as a flexible therapeutic option for localized HCC.