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TACE with HepaSphere microspheres loaded with chemotherapeutic agent: early experience in Italy of a multi-centre study.
C. Massa Saluzzo1, M. Grosso2, C. Vignali3, A. Nicolini4, P. Quaretti1, G. Gallarato2, P. Petruzzi3, S. Crespi4, A. Azzaretti1, F. Melchiorre2, I. Sarti3, L. Martinetti4;
1IRCCS Policlinico San Matteo, Pavia, ITALY, 2ASO Santa Croce e Carle, Cuneo, ITALY, 3Azienda Ospedaliera Pisana P.O. Cisanello, Pisa, ITALY, 4Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena, Milano, ITALY.
Background: To present the early results of multi-centre registry using HepaSphere™ loaded with chemotherapeutic agent for TACE in patients with unresectable HCC. Methods: From December 2005 to December 2006, we have enrolled 44 patients with HCC treated by selective TACE using HepaSphere™ loaded with Doxorubicin or Epirubicin. Diameter of HCC from 20 to 70 mm, with a maximum of 3 lesions. 50 mg chemotherapeutic agent solubilised in 5ml NaCl 0,9% or in 5ml non-ionic isotonic contrast medium (Visipaque 270 mg/ml) have been used. The drug solution has been injected into the Hepasphere vial; 20 min time has been observed to allow the spheres to absorb the drug. 15 ml of non-ionic isotonic contrast medium has then been added; the suspension was then used as a regular embolic to perform selective TACE.
Follow-up with biological examinations and CT scan at 1, 3, 6 and 12 months. Results: No major complications occurred excluding a mild pancreatitis. 11 patients had a post-embolization syndrome that generally seems to be less severe than after conventional TACE. 30 days mortality was 0%; overall mortality rate was 4/44 (11,1%).
Technical success rate was 100%, with complete devascularization of the lesions at the end of all procedures.
One month CT follow-up is available on 41/44 patients. It shows a good result with complete necrosis (100%) of lesions in 43,9% patients, partial necrosis (50-90%) of lesions in 39% patients, and incomplete necrosis (0-49%) of lesions in 17.1%.
Six months CT follow-up is available on 26/44 patients. It shows 100% necrosis in 42,3% patients, partial necrosis in 15,4% patients and incomplete necrosis in 42,3% patients with local recurrence and/or satellite lesions.
The treatment of HCC using HepaSphere™ does not prevent the possibility of new treatment. Actually 6/26 patients at 6 months benefited another treatment like a second procedures of TACE using HepaSphere™ or other. Conclusions: TACE using HepaSphere™ is feasible, with low complications rate and with promising efficacy. The prolonged term contact between drug and tumour should bring additional efficacy and reduced adverse effects of the chemotherapeutic agents. If non complete response, additional treatment can be performed without difficulties.
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