title: Efficacy and safety of micafungin for the prophylaxis of invasive fungal infection during neutropenia in children and adolescents undergoing allogeneic hematopoietic SCT.
abstract: The objective of this study was to evaluate the efficacy and safety of micafungin for the prevention of invasive fungal infection (IFI) during the neutropenic phase of allogeneic hematopoietic SCT (allo-HSCT) in children and adolescents. This was a prospective, multicenter, open-label, single-arm study. Micafungin was administered i.v. at a dose of 1 mg/kg/day (max 50 mg) from the beginning of conditioning until neutrophil engraftment. Treatment success was defined as the absence of proven, probable, possible or suspected IFI through to 4 weeks after therapy. From April 2010 to December 2011, 155 patients were enrolled from 11 institutions in Korea, and 147 patients were analyzed. Of the 147 patients, 121 (82.3%) completed the protocol without premature interruption. Of the 132 patients in whom micafungin efficacy could be evaluated, treatment success was achieved in 119 patients (90.2%). There was no proven fungal infection in any patient. The number of patients with probable, possible and suspected IFI was two, two and nine, respectively. Thirty-five patients (23.8%) experienced 109 adverse events (AEs) possibly related to micafungin. No patients experienced grade IV AEs. Two patients (1.4%) discontinued micafungin administration due to adverse effects. None of the deaths were related to the study drug.
authors.affiliation: Center for Pediatric Oncology, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: H J
authors.initials: HJ
authors.lastname: Park
authors.affiliation: Department of Pediatrics, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.
authors.forename: M
authors.initials: M
authors.lastname: Park
authors.affiliation: Clinical Research Center, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: M
authors.initials: M
authors.lastname: Han
authors.affiliation: Clinical Research Center, National Cancer Center, Goyang-si, Republic of Korea.
authors.forename: B H
authors.initials: BH
authors.lastname: Nam
authors.affiliation: Department of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: K N
authors.initials: KN
authors.lastname: Koh
authors.affiliation: Department of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: H J
authors.initials: HJ
authors.lastname: Im
authors.affiliation: Department of Pediatrics, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: J W
authors.initials: JW
authors.lastname: Lee
authors.affiliation: Department of Pediatrics, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: N-G
authors.initials: NG
authors.lastname: Chung
authors.affiliation: Department of Pediatrics, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: B
authors.initials: B
authors.lastname: Cho
authors.affiliation: Department of Pediatrics, Seoul St Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: H-K
authors.initials: HK
authors.lastname: Kim
authors.affiliation: Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: K H
authors.initials: KH
authors.lastname: Yoo
authors.affiliation: Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
authors.forename: H H
authors.initials: HH
authors.lastname: Koo
authors.affiliation: Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: H J
authors.initials: HJ
authors.lastname: Kang
authors.affiliation: Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: H Y
authors.initials: HY
authors.lastname: Shin
authors.affiliation: Department of Pediatrics, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea.
authors.forename: H S
authors.initials: HS
authors.lastname: Ahn
authors.affiliation: Department of Pediatrics, Pusan National University College of Medicine, Busan, Republic of Korea.
authors.forename: Y T
authors.initials: YT
authors.lastname: Lim
authors.affiliation: Department of Pediatrics, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, Republic of Korea.
authors.forename: H
authors.initials: H
authors.lastname: Kook
authors.affiliation: Department of Pediatrics, Yonsei University, College of Medicine, Seoul, Republic of Korea.
authors.forename: C J
authors.initials: CJ
authors.lastname: Lyu
authors.affiliation: Department of Pediatrics, Yeungnam University College of Medicine, Daegu, Republic of Korea.
authors.forename: J O
authors.initials: JO
authors.lastname: Hah
authors.affiliation: Department of Pediatrics, Ajou University School of Medicine, Suwon, Republic of Korea.
authors.forename: J E
authors.initials: JE
authors.lastname: Park
authors.affiliation: Department of Pediatrics, Chungnam National University School of Medicine, Daejon, Republic of Korea.
authors.forename: Y J
authors.initials: YJ
authors.lastname: Lim
authors.affiliation: Department of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: J J
authors.initials: JJ
authors.lastname: Seo
mesh_terms: D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D054714:Echinocandins / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D055666:Lipopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D000077551:Micafungin; D009503:Neutropenia / Q000382:microbiology*; D011446:Prospective Studies; D019172:Transplantation Conditioning / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D054714:Echinocandins; D055666:Lipopeptides; D000077551:Micafungin