A novel transcatheter arterial infusion chemotherapy using iodized oil and degradable starch microspheres for hepatocellular carcinoma: a prospective randomized trial.
BACKGROUND
We designed a novel transcatheter arterial infusion chemotherapy (TAI) using iodized oil (lipiodol) and degradable starch microspheres (DSM) for hepatocellular carcinoma (HCC) patients. In this study, we investigated the efficacy of TAI using lipiodol and DSM in a prospective randomized trial.


METHODS
We randomly divided 45 patients with HCC into 3 groups: TAI using lipiodol (lipiodol group, n = 15), TAI using DSM (DSM group, n = 15), and TAI using lipiodol and DSM (lipiodol + DSM group, n = 15). In the lipiodol group, a mixture of cisplatin and lipiodol was administered. In the DSM group, a mixture of cisplatin and DSM was administered. In the lipiodol + DSM group, a mixture of cisplatin and lipiodol was administered, followed by DSM.


RESULTS
The response rates were 40% in the lipiodol group, 53.4% in the DSM group, and 80% in the lipiodol + DSM group, respectively. The response rate tended to improve in the lipiodol + DSM group (lipiodol group vs. lipiodol + DSM group, P = 0.07). The median progression-free survival time was 177 days in the lipiodol group, 287 days in the DSM group, and 377 days in the lipiodol + DSM group. The progression-free survival in the lipiodol + DSM group was significantly better than those in the DSM group (P = 0.020) and the lipiodol group (P = 0.035). There were no serious adverse effects among the 3 groups.


CONCLUSIONS
TAI using lipiodol and DSM was superior to TAI using lipiodol only and TAI using DSM only because of improvements in therapeutic effects and progression-free survival.
Yamasaki
Takahiro
T
Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, 1-1-1 Minamikogushi, Ube, Yamaguchi 755-8505, Japan. t.yama@yamaguchi-u.ac.jp
Hamabe
Satoe
S
Saeki
Issei
I
Harima
Yohei
Y
Yamaguchi
Yuhki
Y
Uchida
Koichi
K
Terai
Shuji
S
Sakaida
Isao
I
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000473:pathology / Q000628:therapy*; D016461:Chemoembolization, Therapeutic; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004998:Ethiodized Oil / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013213:Starch / Q000008:administration & dosage* / Q000009:adverse effects; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome
C083286:degradable starch microspheres; D004998:Ethiodized Oil; D013213:Starch; D002945:Cisplatin