Phase II Study on Voriconazole for Treatment of Chinese Patients with Malignant Hematological Disorders and Invasive Aspergillosis

Authors:
  • XHXin-En Huang
    Xin-En Huang
  • YXYan-Li Xu
    Yan-Li Xu
  • XZXiu-Qun Zhang
    Xiu-Qun Zhang
  • ASAi-Ling Su
    Ai-Ling Su
  • ZSZheng-Shan Shen
    Zheng-Shan Shen
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Abstract
Phase II Study on Voriconazole for Treatment of Chinese Patients with Malignant Hematological Disorders and Invasive Aspergillosis Hematological disorders;aspergillus;voriconazole; Objective: To investigate the efficacy and safety of voriconazole in treating Chinese patients with hematological malignancies and invasive aspergillosis. Methods: From March 2007 to April 2012, patients with diagnoses confirmed by CT, GM test and/or PCR assays, were recruited into this study. Aspergillosis of all patients were treated with voriconazole 6 mg/kg intravenous infusion (iv) every 12 h for 1 day, followed by 4 mg/kg IV every 12 h for 10-15 days; Then, switch to oral administration that was 200mg every 12h for 4-12 weeks. Efficacy and safety were evaluated according to Practice Guideline of Infectious Diseases Society of America. Results: The overall response rate of 38 patients after voriconazole treatment was 81.6%. The median time to pyretolysis was 4.5 days. Treatment related side effects were mild and found in only 15.8% of cases. No treatment related deaths occurred. Conclusions: Voriconazole can considered to be a safe and effective front-line therapy to treat patients with hematological malignancies and invasive aspergillosis. Alternatively it could be used as a remedial treatment when other antifungal therapies are ineffective.

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