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.