Yonsei Med J.  2011 Mar;52(2):293-300. 10.3349/ymj.2011.52.2.293.

Efficacy of Itraconazole Prophylaxis for Autologous Stem Cell Transplantation in Children with High-Risk Solid Tumors: A Prospective Double-Blind Randomized Study

• Kim YJ
• Sung KW
• Hwang HS
• Jung SH
• Kim JY
• Cho EJ
• Lim SJ
• Choi YB
• Cheuh HW
• Lee SH
• Yoo KH
• Koo HH

• KMID: 1779666
• DOI: http://doi.org/10.3349/ymj.2011.52.2.293

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).

Keyword

Itraconazole; autologous transplantation; antifungal prophylaxis; solid tumor

MeSH Terms

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

Figure

• 

  Fig. 1 Duration of fever was shorter in the prophylaxis group than in the empirical treatment group. (A) Duration of fever in all patients. (B) Duration of fever in patients who were treated with a thiotepa-containing regimen. (C) Duration of fever in patients who did not have severe diarrhea.

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