Repeated Transarterial Chemoembolization with Degradable Starch Microspheres (DSMs-TACE) of Unresectable Hepatocellular Carcinoma: A Prospective Pilot Study

Abstract

Objective: The aims of this study were to: a) evaluate tumor response rates using modified-Response-evaluation-criteria-in-solid-tumors (mRecist) criteria, b) evaluate safety of Degradable Starch Microspheres Trans-arterial-chemo-embolization (DSMs-TACE) for unresectable hepatocellular-carcinoma (HCC) treatment.

Materials and methods: We prospectively enrolled 24 HCC cirrhotic patients (21/3 M/F, mean age 66.3 years) to be treated with repeated DSMs-TACE procedures, performed at 4-6 week intervals on the basis of tumor response and patients tolerance. Clinical and biochemical evaluations were performed before and after each procedure. Treatment response was also assessed by Computed-tomography (CT) or Magnetic-resonance-imaging (MRI)-scan 4-6 weeks following each procedure.

Results: In our experience, DSMs-TACE was both safe and effective. A total of 53 DSMs-TACE procedures were performed (2.2 per patient). No procedure-related death was observed. Complete Response (CR) was observed in 5/24 (20.8%), 4/17 (23.5%) and 5/12 (41.6%) patients after the first, second and third procedure, respectively. At the end of each treatment, all patients experienced at least a partial response. At the end of the repeated procedures, no differences between mono- or bi-lobar disease were observed in patients with CR (64.2% vs 50%; p=ns). In most cases, treatment discontinuation was due to worsening liver function.

Conclusion: DSMs-TACE is a valid, well-tolerated alternative treatment to Lipiodol-TACE or DEB-TACE, as it has demonstrated to achieve a relatively high percentage of complete tumor necrosis. CR rates were similar between patients with mono- or bi-lobar disease indicating the possibility of carrying-out repeated procedure in a safe and effective way in both types of patients.

Keywords: HCC cirrhotic patients; Hepatocellular carcinoma; degradable starch microspheres; locoregional therapies; recurrence-free survival; transcatheter arterial chemoembolization.

Fig. (1)

a-d. Axial contrast enhanced CT images (a,b,c) show multiple enhanced nodules in patient with multinodular HCC (arrows); hepatic arteriography (d), performed during a DSM TACE procedure, demonstrates multiple areas of non specific arterial enhancement the liver.

Fig. (2)

a-f. Axial dynamic contrast enhanced-CT images show a hypervascular lesion during arterial phase (a) with rapid wash-out during portal (b) and delayed phase (c), localized on VI segment (diameter 32 mm). After two repeated procedures of DMSs-TACE dynamic contrast enhanced-CT (d,e,f) demonstrated a complete response.

Fig. (3)

a-d. Axial dynamic contrast enhanced-CT images show two hypervascular lesions during arterial phase localized on VII segment (a) and on VI segment (c). After one month by a single session of DMSs-TACE dynamic ce-CT shows the absence of contrast enhancement of the lesion on segment VII (b) and persistence of partial contrast enhancement on the anterior margin of the lesion on segment VI (arrow) (d).