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

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.