Clinical and Radiological Outcomes Comparison of Degradable Starch Microspheres TACE with Idarubicin vs. Epirubicin Protocol in Patients with HCC.

Background/Objectives: Transarterial chemoembolization (TACE) is included in international guidelines for the treatment of hepatocellular carcinoma (HCC), but it is still not a standardized intervention in terms of vector and chemotherapy. This study aims to report on clinical and radiological outcomes of degradable starch microspheres TACE (DSM-TACE) with idarubicin and compare with DSM-TACE with an epirubicin protocol after a single session. Methods: This is a single-center retrospective study analyzing cirrhotic patients affected by HCC in early or intermediate stages. Primary objectives were to assess the safety and efficacy of a single DSM-TACE with 10 mg idarubicin in terms of adverse event (AE) occurrences evaluated via the CTCAE 5.0 system and mRECIST criteria with computed tomography (CT) at 3 months. The secondary purpose was to compare the procedural outcomes with those from patients treated with DSM-TACE with 50 mg epirubicin. Results: Thirty-seven patients were included, 19 treated with idarubicin (IDA group) and 18 with epirubicin (EPI group); demographic data and lesion characteristics were comparable. No major AE (grade ≥ 3) occurred overall. In the IDA group, the minor AE incidence was 52.7%: one patient presented with mild ascites, eight developed hyperbilirubinemia and one leucopenia. At the 3-month CT follow-up, mRECIST criteria reported an overall response rate (ORR) of 63.2% and a disease control rate (DCR) of 84.2%. No statistically significant differences were appreciable comparing both AE occurrence and mRECIST findings with the EPI group (50% minor AE, 77.8% ORR, 88.9% DCR). Conclusions: In this sample of cirrhotic patients with HCC, DSM-TACE with 10 mg idarubicin was safe and effective comparable to DSM-TACE with 50 mg epirubicin.