Phase II trial of intra-arterial chemotherapy using a novel lipophilic platinum derivative (SM-11355) in patients with hepatocellular carcinoma.
SM-11355, a lipophilic platinum derivative, is a novel intra-arterial chemotherapeutic agent for hepatocellular carcinoma (HCC). A phase II study of SM-11355 was conducted to evaluate the antitumor activities and the toxicity in chemotherapy-naive patients with HCC. Sixteen patients were treated with transcatheter arterial injection of SM-11355-lipiodol emulsion (20-120 mg/body). The responses were evaluated by computed tomography 3 months after treatment. Complete response (CR) was defined as disappearance or 100% necrosis of all tumors, and lipiodol accumulation in tumors was regarded as indicating necrosis. Nine patients achieved CR (56%; 95% confidence interval, 29.9-80.2%). The grade 3 toxicities were neutropenia (19%), total bilirubin elevation (19%), AST elevation (44%), and ALT elevation (19%). None of the patients showed grade 4 toxicities or episodes of renal dysfunction. Other common adverse effects were eosinophilia (100%) and pyrexia (94%). Intra-arterial chemotherapy with SM-11355, which was well tolerated, showed promising antitumor activity in patients with HCC.
Okusaka
Takuji
T
Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan. tokusaka@ncc.go.jp
Okada
Shuichi
S
Nakanishi
Toshio
T
Fujiyama
Shigetoshi
S
Kubo
Yasuhiko
Y
D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D016001:Confidence Intervals; D015507:Drugs, Investigational / Q000008:administration & dosage* / Q000737:chemistry; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D008055:Lipids / Q000008:administration & dosage / Q000097:blood / Q000737:chemistry; D008113:Liver Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage* / Q000097:blood / Q000737:chemistry; D015996:Survival Rate
D000970:Antineoplastic Agents; D015507:Drugs, Investigational; D008055:Lipids; D009944:Organoplatinum Compounds; C406530:miriplatin