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

Seong Hyun Jeong, Dae Young Kim, Jun Ho Jang, Yeung Chul Mun, Chul Won Choi, Sung Hyun Kim, Jin Seok Kim, Joon Seong Park

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)337-344
Number of pages8
JournalAnnals of Hematology
Volume95
Issue number2
DOIs
Publication statusPublished - 2016 Jan 1

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Itraconazole
Hematologic Neoplasms
Multicenter Studies
Fever
Prospective Studies
Safety
Febrile Neutropenia
Length of Stay
Therapeutics
Chronic Idiopathic Jaundice
Echinocandins
micafungin
Azoles
Survival
Mycoses
Anaphylaxis
Transaminases
Pharmaceutical Preparations
Atrial Fibrillation
Electrolytes

All Science Journal Classification (ASJC) codes

  • Hematology

Cite this

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title = "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",
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.",
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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. / Jeong, Seong Hyun; Kim, Dae Young; Jang, Jun Ho; Mun, Yeung Chul; Choi, Chul Won; Kim, Sung Hyun; Kim, Jin Seok; Park, Joon Seong.

In: Annals of Hematology, Vol. 95, No. 2, 01.01.2016, p. 337-344.

Research output: Contribution to journalArticle

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T1 - Efficacy and safety of micafungin versus intravenous itraconazole as empirical antifungal therapy for febrile neutropenic patients with hematological malignancies

T2 - a randomized, controlled, prospective, multicenter study

AU - Jeong, Seong Hyun

AU - Kim, Dae Young

AU - Jang, Jun Ho

AU - Mun, Yeung Chul

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AU - Kim, Sung Hyun

AU - Kim, Jin Seok

AU - Park, Joon Seong

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