title: Efficacy and safety of micafungin as an empirical therapy for invasive fungal infections in patients with hematologic disorders: a multicenter, prospective study.
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.
authors.affiliation: Department of Hematology, Ishikawa Prefectural Central Hospital, 2-1 Kuratsukihigashi, Kanazawa City, Ishikawa, Japan. myjody@ipch.jp
authors.forename: Masaki
authors.initials: M
authors.lastname: Yamaguchi
authors.forename: Toshiro
authors.initials: T
authors.lastname: Kurokawa
authors.forename: Ken
authors.initials: K
authors.lastname: Ishiyama
authors.forename: Go
authors.initials: G
authors.lastname: Aoki
authors.forename: Mikio
authors.initials: M
authors.lastname: Ueda
authors.forename: Sadaya
authors.initials: S
authors.lastname: Matano
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Takami
authors.forename: Hirohito
authors.initials: H
authors.lastname: Yamazaki
authors.forename: Aiko
authors.initials: A
authors.lastname: Sawazaki
authors.forename: Hiromasa
authors.initials: H
authors.lastname: Yamauchi
authors.forename: Takashi
authors.initials: T
authors.lastname: Yoshida
authors.forename: Shinji
authors.initials: S
authors.lastname: Nakao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000942:Antigens, Bacterial / Q000097:blood; D001228:Aspergillosis / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000517:prevention & control; D058365:Candidiasis, Invasive / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000517:prevention & control; D056486:Chemical and Drug Induced Liver Injury / Q000453:epidemiology; D042241:Early Diagnosis; D054714:Echinocandins / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D005690:Galactose / Q000031:analogs & derivatives; D019337:Hematologic Neoplasms / Q000150:complications*; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000150:complications; D055666:Lipopeptides / Q000009:adverse effects* / Q000627:therapeutic use; D008223:Lymphoma / Q000150:complications; D008297:Male; D008351:Mannans / Q000097:blood; D000077551:Micafungin; D008875:Middle Aged; D009181:Mycoses / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000517:prevention & control*; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000150:complications; D055815:Young Adult; D047071:beta-Glucans / Q000097:blood
chemical_list: D000935:Antifungal Agents; D000942:Antigens, Bacterial; D054714:Echinocandins; D055666:Lipopeptides; D008351:Mannans; D047071:beta-Glucans; C012990:galactomannan; D000077551:Micafungin; D005690:Galactose