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Phase II Trial of Intra-Arterial Chemotherapy using a Novel Lipophilic Platinum Derivative (SM-11355) in Patients with Hepatocellular Carcinoma

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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.

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Authors and Affiliations

  1. Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, Tokyo, Japan

    Takuji Okusaka & Shuichi Okada

  2. First Department of Internal Medicine, Hiroshima University School of Medicine, Hiroshima, Japan

    Toshio Nakanishi

  3. Third Department of Internal Medicine, Kumamoto University School of Medicine, Kumamoto, Japan

    Shigetoshi Fujiyama

  4. Department of Internal Medicine, Omuta City General Hospital, Fukuoka, Japan

    Yasuhiko Kubo

Authors
  1. Takuji Okusaka
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  2. Shuichi Okada
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  3. Toshio Nakanishi
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  4. Shigetoshi Fujiyama
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  5. Yasuhiko Kubo
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Okusaka, T., Okada, S., Nakanishi, T. et al. Phase II Trial of Intra-Arterial Chemotherapy using a Novel Lipophilic Platinum Derivative (SM-11355) in Patients with Hepatocellular Carcinoma. Invest New Drugs 22, 169–176 (2004). https://doi.org/10.1023/B:DRUG.0000011793.72775.d1

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  • DOI: https://doi.org/10.1023/B:DRUG.0000011793.72775.d1

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