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Published in: Annals of Hematology 10/2011

01-10-2011 | Original Article

Efficacy and safety of micafungin as an empirical therapy for invasive fungal infections in patients with hematologic disorders: a multicenter, prospective study

Authors: Masaki Yamaguchi, Toshiro Kurokawa, Ken Ishiyama, Go Aoki, Mikio Ueda, Sadaya Matano, Akiyoshi Takami, Hirohito Yamazaki, Aiko Sawazaki, Hiromasa Yamauchi, Takashi Yoshida, Shinji Nakao

Published in: Annals of Hematology | Issue 10/2011

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Abstract

This study was conducted as a prospective, multicenter trial to evaluate the efficacy and safety of micafungin as an empirical therapy for suspected invasive fungal infections (IFIs), including febrile neutropenia (FN), and to evaluate the usefulness of β-d-glucan (BG) and Aspergillus galactomannan (GM) antigen in patients with hematologic diseases. A total of 121 patients were enrolled and assessed for safety, and 119 were examined for clinical efficacy. The main underlying diseases were acute myeloid leukemia (38.0%), acute lymphoblastic leukemia (18.2%), and malignant lymphoma (18.2%). The median initial daily dose and duration of micafungin treatment were 150 mg/day and 13 days, respectively. The overall response rate for suspected IFIs (n = 119), based on four composite endpoints, including baseline IFI, breakthrough IFIs (proven and probable), survival, and premature discontinuation, was 79.0%. In addition, the response rate for FN (n = 81), based on these four endpoints as well as defervescence during neutropenia, was 39.5%. Breakthrough IFIs (proven, probable, and possible) occurred in five patients during micafungin treatment. All of these patients were positive for either BG or GM before the breakthrough IFIs. The incidence of adverse events (AEs) associated with micafungin was 10.7% and most were mild. The majority of AEs were liver dysfunction. These results indicate the effectiveness and safety of micafungin as an empirical therapy for suspected IFIs, including FN, and the usefulness of monitoring both BG and GM to detect breakthrough IFIs.
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Metadata
Title
Efficacy and safety of micafungin as an empirical therapy for invasive fungal infections in patients with hematologic disorders: a multicenter, prospective study
Authors
Masaki Yamaguchi
Toshiro Kurokawa
Ken Ishiyama
Go Aoki
Mikio Ueda
Sadaya Matano
Akiyoshi Takami
Hirohito Yamazaki
Aiko Sawazaki
Hiromasa Yamauchi
Takashi Yoshida
Shinji Nakao
Publication date
01-10-2011
Publisher
Springer-Verlag
Published in
Annals of Hematology / Issue 10/2011
Print ISSN: 0939-5555
Electronic ISSN: 1432-0584
DOI
https://doi.org/10.1007/s00277-011-1277-1

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