Efficacy of Itraconazole Prophylaxis for Autologous Stem Cell Transplantation in Children with High-Risk Solid Tumors: A Prospective Double-Blind Randomized Study.
10.3349/ymj.2011.52.2.293
- Author:
Yae Jean KIM
1
;
Ki Woong SUNG
;
Hye Sook HWANG
;
Shin Han JUNG
;
Ju Youn KIM
;
Eun Joo CHO
;
Su Jin LIM
;
Young Bae CHOI
;
Hee Won CHEUH
;
Soo Hyun LEE
;
Keon Hee YOO
;
Hong Hoe KOO
Author Information
1. Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. kwsped@skku.edu
- Publication Type:Original Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
- Keywords:
Itraconazole;
autologous transplantation;
antifungal prophylaxis;
solid tumor
- MeSH:
Anti-Bacterial Agents/therapeutic use;
Antifungal Agents/*therapeutic use;
Child, Preschool;
Cost-Benefit Analysis;
Double-Blind Method;
Hematopoietic Stem Cell Transplantation/*adverse effects;
Humans;
Itraconazole/*therapeutic use;
Mycoses/*prevention & control;
Neoplasms/*surgery;
Prospective Studies;
Risk Factors;
Transplantation, Autologous;
Treatment Outcome
- From:Yonsei Medical Journal
2011;52(2):293-300
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: The risk of invasive fungal infection is greater for allogeneic hematopoietic stem cell transplantation (HSCT) than for autologous transplantation. Therefore, many transplantation centers use antifungal prophylaxis for allogeneic HSCT, however, there exists no standard guidelines or consensus regarding autologous HSCT. MATERIALS AND METHODS: A prospective double-blind randomized study was conducted in autologous HSCT recipients who were divided into prophylaxis and empirical treatment groups, and we investigated the efficacy of itraconazole prophylaxis in pediatric autologous HSCT. RESULTS: Total 87 autologous HSCT episodes in 55 children with high-risk solid tumors were studied. No invasive fungal infections occurred in either group. However, patients in the prophylaxis group had a significantly shorter duration of fever (p < 0.05) and received antibacterial treatment of shorter duration (p < 0.05) with fewer numbers of antibiotics (p < 0.05 for the use of second line antibiotics) than those in the empirical group. No significant additional adverse events were found with itraconazole prophylaxis. CONCLUSION: Although beneficial effects such as a shorter duration of fever and reduced need for antibiotic use were observed in the prophylaxis group, the results were not sufficient to draw a definite recommendation about the routine use of antifungal prophylaxis in pediatric autologous HSCT recipients with high-risk solid tumors (Trial registration: NCT00336531).
