Pilot study of transarterial chemoembolization with pirarubicin and amiodarone for unresectable hepatocellular carcinoma.
OBJECTIVE
Further to a previous study whereby we reported that an in vitro emulsion of pirarubicin, amiodarone, and lipiodol was more stable and cytotoxic than a classic doxorubicin-lipiodol mixture, we designed a pilot study to evaluate efficacy and toxicity of a transarterial chemoembolization (TACE) procedure using a combination of pirarubicin, amiodarone, lipiodol, and gelatin sponge.


METHODS
The 43 patients included in this study underwent TACE for unresectable hepatocellular carcinoma. Computed tomography scans were performed to assess tumor response (RECIST) and lipiodol uptake after the first session. Median follow-up lasted 30 months. Endpoints were overall and progression-free survival. Survival was estimated using Kaplan Meier estimations and compared using log-rank tests. Univariate and multivariate Cox analyses were used to calculate hazard ratios with their 95% confidence interval (CI).


RESULTS
Twenty-seven (67.5%) patients had alcoholic cirrhosis. Mean tumor size was 9.5 cm (1-20 cm) and 37/43 were multifocal or diffuse. Cancer of the liver Italian program score was 0 in 7/40 and 1 in 16/40. Mean number of TACE sessions was 3.5 (1-11). There were 3 treatment-related deaths (2 severe sepsis, 1 bowel perforation). A partial response and a stable disease were observed in 12 (28%) and 29 (67%) patients, respectively. Median overall and progression-free survivals were 29 months (95% CI: 13.8-45) and 15 months (95% CI: 11.5-20.8), respectively. Cancer of the liver Italian program score <or=1 (P = 0.042) and lipiodol uptake >25% (P = 0.003) were independent prognostic factors for better overall survival.


CONCLUSIONS
This new TACE procedure is safe with a high overall survival rate and certainly deserves phase III investigation to compare it with classic treatments such as doxorubicin-lipiodol TACE.
Guiu
Boris
B
Departments of Interventional Radiology, University Hospital le Bocage, Dijon, France. boris.guiu@chu-dijon.fr
Colin
Cédric
C
Cercueil
Jean-Pierre
JP
Loffroy
Romaric
R
Guiu
Séverine
S
Ferrant
Emmanuelle
E
Jouve
Jean-Louis
JL
Bonnetain
Franck
F
Boulin
Mathieu
M
Ghiringhelli
François
F
Minello
Anne
A
Hillon
Patrick
P
Bedenne
Laurent
L
Krause
Denis
D
Chauffert
Bruno
B
D000368:Aged; D000369:Aged, 80 and over; D000638:Amiodarone / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000494:pharmacology; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D016461:Chemoembolization, Therapeutic; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D007459:Iodized Oil / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011379:Prognosis; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D007166:Immunosuppressive Agents; D007459:Iodized Oil; D004317:Doxorubicin; C027260:pirarubicin; D000638:Amiodarone