Efficacy and safety of micafungin versus intravenous itraconazole as empirical antifungal therapy for febrile neutropenic patients with hematological malignancies: a randomized, controlled, prospective, multicenter studyReport as inadecuate




Efficacy and safety of micafungin versus intravenous itraconazole as empirical antifungal therapy for febrile neutropenic patients with hematological malignancies: a randomized, controlled, prospective, multicenter study - Download this document for free, or read online. Document in PDF available to download.

Annals of Hematology

, Volume 95, Issue 2, pp 337–344

First Online: 24 November 2015Received: 24 June 2015Accepted: 01 November 2015DOI: 10.1007-s00277-015-2545-2

Cite this article as: Jeong, S.H., Kim, D.Y., Jang, J.H. et al. Ann Hematol 2016 95: 337. doi:10.1007-s00277-015-2545-2

Abstract

Micafungin, a clinically important echinocandin antifungal drug, needs to be investigated as empirical therapy in febrile neutropenia in comparison with azole compounds. A prospective randomized study was conducted to compare clinical outcomes between micafungin and intravenous itraconazole as an empirical therapy for febrile neutropenia in hematological malignancies. The antifungal drug micafungin 100 mg or itraconazole 200 mg IV once daily was given for high fever that was sustained despite the administration of appropriate antibiotics. Treatment success was determined by composite end points based on breakthrough invasive fungal infection IFI, survival, premature discontinuation, defervescence, and treatment of baseline fungal infection. Duration of fever, hospital stay, and overall survival OS were studied. A total of 153 patients were randomized to receive micafungin or itraconazole. The overall success rate was 7.1 % point higher in the micafungin group 64.4 vs. 57.3 %, p = 0.404, satisfying the statistical criteria for the non-inferiority of micafungin. The duration of fever and hospital stay were significantly shorter in the micafungin group 6 vs. 7 days, p = 0.014; 22 vs. 27 days, p = 0.033, respectively. Grade 3 adverse events including hyperbilirubinemia 2 vs. 7, elevation of transaminase levels 2 vs. 4, electrolyte imbalance 1 vs. 2, atrial fibrillation 1 vs. 0, and anaphylaxis 1 vs. 0 occurred in 7 and 13 patients in the micafungin 10.4 % and itraconazole 18.8 % groups, respectively. Micafungin, when compared with itraconazole, had favorably comparable success rate and toxicity profiles on febrile neutropenia in patients with hematological malignancies. In addition, it showed superior effect on shortening the hospital stay.

KeywordsMicafungin Empirical Febrile neutropenia  Download fulltext PDF



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