PMID- 35327744 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220329 IS - 2227-9067 (Print) IS - 2227-9067 (Electronic) IS - 2227-9067 (Linking) VI - 9 IP - 3 DP - 2022 Mar 7 TI - Prospective Study on Prophylactic Micafungin Sodium against Invasive Fungal Disease during Neutropenia in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation. LID - 10.3390/children9030372 [doi] LID - 372 AB - BACKGROUND: Invasive fungal diseases (IFDs) increase the mortality rate of patients with neutropenia who receive chemotherapy or have previously undergone hematopoietic stem cell transplantation (HSCT). Micafungin is a broad-spectrum echinocandin with minimal toxicity and low drug interactions. We therefore investigated the efficacy and safety of prophylactic micafungin in pediatric and adolescent patients who underwent autologous HSCT. METHODS: This was a phase II, prospective, single-center, open-label, and single-arm study. From November 2011 to February 2017, 125 patients were screened from Seoul National University Children's Hospital, Korea, and 112 were enrolled. Micafungin was administered intravenously at a dose of 1 mg/kg/day (maximum 50 mg/day) from day 8 of autologous HSCT until neutrophil engraftment. Treatment success was defined as the absence of proven, probable, or possible IFD up to 4 weeks after therapy. RESULTS: The study protocol was achieved without premature interruption in 110 patients (98.2%). The reasons interrupting micafungin treatment included early death (n = 1) and patient refusal (n = 1). Treatment success was achieved in 109 patients (99.1%). Only one patient was diagnosed with probable IFD. No patients were diagnosed with possible or proven IFD. In the full analysis set, 21 patients (18.8%) experienced 22 adverse events (AEs); however, all AEs were classified as "unlikely" related to micafungin. No patient experienced grade IV AEs nor discontinued treatment, and none of the deaths were related to micafungin. CONCLUSIONS: Our study demonstrated that micafungin is a safe and effective option for antifungal prophylaxis in pediatric patients who underwent autologous HSCT, with promising efficacy without significant AEs. FAU - Kim, Bo-Kyung AU - Kim BK AD - Department of Pediatrics, College of Medicine, Seoul National University, Seoul 03080, Korea. AD - Cancer Research Institute, Seoul National University, Seoul 03080, Korea. AD - Wide River Institute of Immunology, Hongcheon 25159, Korea. FAU - Choi, Jung-Yoon AU - Choi JY AD - Department of Pediatrics, College of Medicine, Seoul National University, Seoul 03080, Korea. AD - Cancer Research Institute, Seoul National University, Seoul 03080, Korea. AD - Wide River Institute of Immunology, Hongcheon 25159, Korea. FAU - Hong, Kyung-Taek AU - Hong KT AUID- ORCID: 0000-0002-8822-1988 AD - Department of Pediatrics, College of Medicine, Seoul National University, Seoul 03080, Korea. AD - Cancer Research Institute, Seoul National University, Seoul 03080, Korea. AD - Wide River Institute of Immunology, Hongcheon 25159, Korea. FAU - An, Hong-Yul AU - An HY AD - Department of Pediatrics, College of Medicine, Seoul National University, Seoul 03080, Korea. AD - Cancer Research Institute, Seoul National University, Seoul 03080, Korea. AD - Wide River Institute of Immunology, Hongcheon 25159, Korea. FAU - Shin, Hee-Young AU - Shin HY AD - Department of Pediatrics, College of Medicine, Seoul National University, Seoul 03080, Korea. AD - Cancer Research Institute, Seoul National University, Seoul 03080, Korea. AD - Wide River Institute of Immunology, Hongcheon 25159, Korea. FAU - Kang, Hyoung-Jin AU - Kang HJ AD - Department of Pediatrics, College of Medicine, Seoul National University, Seoul 03080, Korea. AD - Cancer Research Institute, Seoul National University, Seoul 03080, Korea. AD - Wide River Institute of Immunology, Hongcheon 25159, Korea. LA - eng GR - AKR-MYC-2011-03/Astellas Pharma (South Korea)/ PT - Journal Article DEP - 20220307 PL - Switzerland TA - Children (Basel) JT - Children (Basel, Switzerland) JID - 101648936 PMC - PMC8947337 OTO - NOTNLM OT - adolescent OT - autologous hematopoietic stem cell transplantation OT - invasive fungal disease OT - micafungin OT - pediatric COIS- The authors declare no conflict of interest. EDAT- 2022/03/26 06:00 MHDA- 2022/03/26 06:01 PMCR- 2022/03/07 CRDT- 2022/03/25 01:05 PHST- 2021/12/23 00:00 [received] PHST- 2022/02/18 00:00 [revised] PHST- 2022/02/28 00:00 [accepted] PHST- 2022/03/25 01:05 [entrez] PHST- 2022/03/26 06:00 [pubmed] PHST- 2022/03/26 06:01 [medline] PHST- 2022/03/07 00:00 [pmc-release] AID - children9030372 [pii] AID - children-09-00372 [pii] AID - 10.3390/children9030372 [doi] PST - epublish SO - Children (Basel). 2022 Mar 7;9(3):372. doi: 10.3390/children9030372.