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

Zhou, Qinghua and Sun, Xun and Zeng, Lingyuan and Liu, Jie and Zhang, Zhirong (2009) A randomized multicenter phase II clinical trial of mitoxantrone-loaded nanoparticles in the treatment of 108 patients with unresected hepatocellular carcinoma. Nanomedicine: Nanotechnology, Biology and Medicine, 5 (4). 419 - 423.

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Official URL: http://www.sciencedirect.com/science/article/B7MDB...

Abstract

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.

Item Type:Article
Uncontrolled Keywords:Phase II clinical trial; Mitoxantrone; Polybutylcyanacrylate nanoparticles; Unresected hepatocellular carcinoma
Subjects:Biomedical Science > Nanomedicine
ID Code:8581
Deposited By:SPI
Deposited On:22 Apr 2010 11:05
Last Modified:22 Apr 2010 11:05

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