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

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Abstract
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.

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