Nanomedicine: Nanotechnology, Biology and Medicine
Volume 5, Issue 4 , Pages 419-423, December 2009

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

  • Qinghua Zhou, PhD

      Affiliations

    • Key Laboratory of Drug Targeting and Drug Delivery Systems, Ministry of Education, West China School of Pharmacy，Sichuan University, Chengdu, China
    • West China Hospital, Sichuan University, Chengdu, China
    • These authors contributed equally to this work.
    • ,
  • Xun Sun, PhD

      Affiliations

    • Key Laboratory of Drug Targeting and Drug Delivery Systems, Ministry of Education, West China School of Pharmacy，Sichuan University, Chengdu, China
    • These authors contributed equally to this work.
    • ,
  • Lingyuan Zeng, BS

      Affiliations

    • Sichuan Provincial Cancer Hospital, Chengdu, China
    • ,
  • Jie Liu, PhD

      Affiliations

    • Key Laboratory of Drug Targeting and Drug Delivery Systems, Ministry of Education, West China School of Pharmacy，Sichuan University, Chengdu, China
    • ,
  • Zhirong Zhang, PhD

      Affiliations

    • Key Laboratory of Drug Targeting and Drug Delivery Systems, Ministry of Education, West China School of Pharmacy，Sichuan University, Chengdu, China
    • Corresponding Author InformationCorresponding author. Key Laboratory of Drug Targeting and Drug Delivery Systems, Ministry of Education, West China School of Pharmacy, Sichuan University, Chengdu, China.

Received 31 October 2008; accepted 16 January 2009. published online 17 February 2009.

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.

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.

Key words: Phase II clinical trial, Mitoxantrone, Polybutylcyanacrylate nanoparticles, Unresected hepatocellular carcinoma

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 This work was supported by a grant from the National High Research and Development Program of China (863 program) (Grant 2007AA021800).

PII: S1549-9634(09)00047-1

doi:10.1016/j.nano.2009.01.009

Nanomedicine: Nanotechnology, Biology and Medicine
Volume 5, Issue 4 , Pages 419-423, December 2009

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