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 Computedtomography
(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.