A randomized multicenter phase II clinical trial of mitoxantrone-loaded nanoparticles in the treatment of 108 patients with unresected hepatocellular carcinoma

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• 作者：Qinghua Zhou ; Xun Sun ; Lingyuan Zeng ; Jie Liu ; Zhirong Zhang
• 关键词：Phase II clinical trial ; Mitoxantrone ; Polybutylcyanacrylate nanoparticles ; Unresected hepatocellular carcinoma
• 刊名：Nanomedicine: Nanotechnology, Biology and Medicine
• 出版年：2009
• 出版时间：December 2009
• 年：2009
• 卷：5
• 期：4
• 页码：419-423
• 全文大小：150 K

文摘

Previous studies have demonstrated that intravenous administration of mitoxantrone-loaded polybutylcyanacrylate nanoparticles (DHAD-PBCA-NPs) could allow increased cytotoxicity in hepatic tumors. Therefore, we evaluated the activity and toxicity of DHAD-PBCA-NPs and DHAD injection in individuals with unresected hepatocellular carcinoma. For the DHAD-PBCA-NPs arm the objective response rate was 10.5 % , 61.4 % patients had stable disease, and 28.1 % patients had progression. For the DHAD injection arm no objective response was found, 45.1 % patients had stable disease, and 54.9 % patients had progression. There were significant differences in both stable disease and progressive disease between the two groups (P< .05). The median survival periods of the DHAD-PBCA-NPs group and the DHAD injection group were 5.46 months and 3.23 months, respectively. Leukopenia was observed in 47.4 % and 74.5 % of the DHAD-PBCA-NPs arm and the DHAD injection arm, respectively. Meanwhile, anemia was noted in 65 % and 37.3 % of the DHAD-PBCA-NPs arm and the DHAD injection arm, respectively.

From the Clinical Editor

Intravenous administration of mitoxantrone-loaded polybutylcyanacrylate nanoparticles (DHAD-PBCA-NPs) allows increased cytotoxicity in hepatic tumors and prolonged the median survival periods to 5.46 months compared to 3.23 months in controls.