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

Abstract

<br/><b>Objective</b>: To investigate the efficacy and safety of voriconazole in treating Chinese patients with hematologicalmalignancies and invasive aspergillosis. <br/><b>Methods</b>: From March 2007 to April 2012, patients with diagnosesconfirmed by CT, GM test and/or PCR assays, were recruited into this study. Aspergillosis of all patients weretreated with voriconazole 6 mg/kg intravenous infusion (iv) every 12 h for 1 day, followed by 4 mg/kg IV every12 h for 10-15 days; Then, switch to oral administration that was 200mg every 12h for 4-12 weeks. Efficacy andsafety were evaluated according to Practice Guideline of Infectious Diseases Society of America. <br/><b>Results</b>: Theoverall response rate of 38 patients after voriconazole treatment was 81.6%. The median time to pyretolysiswas 4.5 days. Treatment related side effects were mild and found in only 15.8% of cases. No treatment relateddeaths occurred. <br/><b>Conclusions</b>: Voriconazole can considered to be a safe and effective front-line therapy to treatpatients with hematological malignancies and invasive aspergillosis. Alternatively it could be used as a remedialtreatment when other antifungal therapies are ineffective.