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.
authors.affiliation: Department of Hematology-Oncology, Ajou University Hospital, Ajou Univesity School of Medicine, Suwon, South Korea.
authors.forename: Seong Hyun
authors.initials: SH
authors.lastname: Jeong
authors.affiliation: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Kim
authors.affiliation: Division of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Jang
authors.affiliation: Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Ewha Womans Univerity School of Medicine, Seoul, South Korea.
authors.forename: Yeung-Chul
authors.initials: YC
authors.lastname: Mun
authors.affiliation: Division of Oncology-Hematology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea.
authors.forename: Chul Won
authors.initials: CW
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, Dong-A University College of Medicine, Busan, South Korea.
authors.forename: Sung-Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Division of Hematology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
authors.forename: Jin Seok
authors.initials: JS
authors.lastname: Kim
authors.affiliation: Department of Hematology-Oncology, Ajou University Hospital, Ajou Univesity School of Medicine, Suwon, South Korea. jspark65@ajou.ac.kr.
authors.forename: Joon Seong
authors.initials: JS
authors.lastname: Park
mesh_terms: D061605:Administration, Intravenous; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D054714:Echinocandins / Q000008:administration & dosage* / Q000009:adverse effects; D036262:Empirical Research; D064147:Febrile Neutropenia / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D019337:Hematologic Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage* / Q000009:adverse effects; D007902:Length of Stay / Q000639:trends; D055666:Lipopeptides / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D000077551:Micafungin; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D054714:Echinocandins; D055666:Lipopeptides; D017964:Itraconazole; D000077551:Micafungin
keywords: Empirical; Febrile neutropenia; Micafungin