PMID- 21695388
OWN - NLM
STAT- MEDLINE
DCOM- 20111027
LR  - 20211203
IS  - 1432-0584 (Electronic)
IS  - 0939-5555 (Linking)
VI  - 90
IP  - 10
DP  - 2011 Oct
TI  - Efficacy and safety of micafungin as an empirical therapy for invasive fungal 
      infections in patients with hematologic disorders: a multicenter, prospective 
      study.
PG  - 1209-17
LID - 10.1007/s00277-011-1277-1 [doi]
AB  - 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 beta-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.
FAU - Yamaguchi, Masaki
AU  - Yamaguchi M
AD  - Department of Hematology, Ishikawa Prefectural Central Hospital, 2-1 
      Kuratsukihigashi, Kanazawa City, Ishikawa, Japan. myjody@ipch.jp
FAU - Kurokawa, Toshiro
AU  - Kurokawa T
FAU - Ishiyama, Ken
AU  - Ishiyama K
FAU - Aoki, Go
AU  - Aoki G
FAU - Ueda, Mikio
AU  - Ueda M
FAU - Matano, Sadaya
AU  - Matano S
FAU - Takami, Akiyoshi
AU  - Takami A
FAU - Yamazaki, Hirohito
AU  - Yamazaki H
FAU - Sawazaki, Aiko
AU  - Sawazaki A
FAU - Yamauchi, Hiromasa
AU  - Yamauchi H
FAU - Yoshida, Takashi
AU  - Yoshida T
FAU - Nakao, Shinji
AU  - Nakao S
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20110622
PL  - Germany
TA  - Ann Hematol
JT  - Annals of hematology
JID - 9107334
RN  - 0 (Antifungal Agents)
RN  - 0 (Antigens, Bacterial)
RN  - 0 (Echinocandins)
RN  - 0 (Lipopeptides)
RN  - 0 (Mannans)
RN  - 0 (beta-Glucans)
RN  - 11078-30-1 (galactomannan)
RN  - R10H71BSWG (Micafungin)
RN  - X2RN3Q8DNE (Galactose)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antifungal Agents/*adverse effects/therapeutic use
MH  - Antigens, Bacterial/blood
MH  - Aspergillosis/complications/diagnosis/drug therapy/prevention & control
MH  - Candidiasis, Invasive/complications/diagnosis/drug therapy/prevention & control
MH  - Chemical and Drug Induced Liver Injury/epidemiology
MH  - Early Diagnosis
MH  - Echinocandins/*adverse effects/therapeutic use
MH  - Female
MH  - Galactose/analogs & derivatives
MH  - Hematologic Neoplasms/*complications
MH  - Humans
MH  - Leukemia, Myeloid, Acute/complications
MH  - Lipopeptides/*adverse effects/therapeutic use
MH  - Lymphoma/complications
MH  - Male
MH  - Mannans/blood
MH  - Micafungin
MH  - Middle Aged
MH  - Mycoses/complications/diagnosis/drug therapy/*prevention & control
MH  - Precursor Cell Lymphoblastic Leukemia-Lymphoma/complications
MH  - Young Adult
MH  - beta-Glucans/blood
EDAT- 2011/06/23 06:00
MHDA- 2011/10/28 06:00
CRDT- 2011/06/23 06:00
PHST- 2010/09/28 00:00 [received]
PHST- 2011/06/07 00:00 [accepted]
PHST- 2011/06/23 06:00 [entrez]
PHST- 2011/06/23 06:00 [pubmed]
PHST- 2011/10/28 06:00 [medline]
AID - 10.1007/s00277-011-1277-1 [doi]
PST - ppublish
SO  - Ann Hematol. 2011 Oct;90(10):1209-17. doi: 10.1007/s00277-011-1277-1. Epub 2011 
      Jun 22.