Itraconazole versus fluconazole for prevention of fungal infections in patients receiving allogeneic stem cell transplants.

Abstract:

:Prophylactic fluconazole prevents candidiasis; however, this drug has no activity against molds. We performed a randomized trial to determine whether prophylactic itraconazole prevents invasive mold infections (IMIs). A total of 304 patients receiving allogeneic stem cell transplants (SCT) were randomized to receive fluconazole (400 mg/d) or itraconazole (oral solution 2.5 mg/kg 3 times daily, or intravenous 200 mg daily) for 180 days after SC transplantation, or until 4 weeks after discontinuation of graft-versus-host disease (GVHD) therapy. Proven or probable invasive fungal infections (IFI) were evaluated by intent-to-treat and "on-treatment" analyses. More patients in the itraconazole arm developed hepatotoxicities, and more patients were discontinued from itraconazole because of toxicities or gastrointestinal (GI) intolerance (36% versus 16%, P <.001). Intent-to-treat analysis demonstrated no difference in the incidence of IFI during the intended study period (fluconazole 16% versus itraconazole 13%, P =.46); however, fewer patients in the itraconazole arm developed IFI on treatment (fluconazole 15% versus itraconazole 7%, P =.03). Itraconazole provided better protection against IMI (fluconazole 12% versus itraconazole 5%, P =.03), but similar protection against candidiasis (3% versus 2%, P =.69). There was no difference in overall or fungal-free survival. Itraconazole appears to prevent IMI in the subset of patients who tolerate the drug; however, toxicities and poor tolerability limit its success as prophylactic therapy.

journal_name

Blood

journal_title

Blood

authors

Marr KA,Crippa F,Leisenring W,Hoyle M,Boeckh M,Balajee SA,Nichols WG,Musher B,Corey L

doi

10.1182/blood-2003-08-2644

subject

Has Abstract

pub_date

2004-02-15 00:00:00

pages

1527-33

issue

4

eissn

0006-4971

issn

1528-0020

pii

2003-08-2644

journal_volume

103

pub_type

临床试验,杂志文章,随机对照试验

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