Phase II trial of intra-arterial chemotherapy using a novel lipophilic platinum derivative (SM-11355) in patients with hepatocellular carcinoma.

Abstract

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.

• Authors: Takuji Okusaka, Shuichi Okada, Toshio Nakanishi, Shigetoshi Fujiyama, Yasuhiko Kubo
• Journal: Investigational new drugs (Invest New Drugs) Vol. 22 Issue 2 Pg. 169-76 (Apr 2004) ISSN: 0167-6997 [Print] United States
• PMID: 14739665 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Drugs, Investigational
• Lipids
• Organoplatinum Compounds
• miriplatin

Topics

• Aged
• Antineoplastic Agents (administration & dosage, blood, chemistry)
• Carcinoma, Hepatocellular (blood, drug therapy, mortality)
• Confidence Intervals
• Drugs, Investigational (administration & dosage, chemistry)
• Female
• Humans
• Infusions, Intra-Arterial
• Lipids (administration & dosage, blood, chemistry)
• Liver Neoplasms (blood, drug therapy, mortality)
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage, blood, chemistry)
• Survival Rate