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


BACKGROUND
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.
Zhou
Qinghua
Q
Key Laboratory of Drug Targeting and Drug Delivery Systems, Ministry of Education, West China School of Pharmacy, Sichuan University, Chengdu, China.
Sun
Xun
X
Zeng
Lingyuan
L
Liu
Jie
J
Zhang
Zhirong
Z
D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000188:drug therapy* / Q000601:surgery*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000009:adverse effects / Q000627:therapeutic use*; D050997:Nanomedicine; D053758:Nanoparticles / Q000009:adverse effects / Q000737:chemistry*; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult; D000509:alpha-Fetoproteins / Q000378:metabolism
D000964:Antimetabolites, Antineoplastic; D000509:alpha-Fetoproteins; D008942:Mitoxantrone