The prophylactic effect of itraconazole capsules and fluconazole capsules for systemic fungal infections in patients with acute myeloid leukemia and myelodysplastic syndromes: a Japanese multicenter randomized, controlled study.
We performed a randomized, controlled study comparing the prophylactic effects of capsule forms of fluconazole (n = 110) and itraconazole (n = 108) in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) during and after chemotherapy. There were 4 cases with possible systemic fungal infection in the itraconazole group, and there were 8 possible and 3 probable cases in the fluconazole group. Adverse events did not significantly differ in the 2 groups. In patients with MDS or in the remission-induction phase of chemotherapy, the numbers of cases with probable or possible infections were lower in the itraconazole group than in the fluconazole group, whereas no difference was seen in patients with AML or in the consolidation phase of therapy. In patients with neutrophil counts of >0.1 x 10(9)/L lasting for more than 4 weeks, the frequency of infection in the fluconazole group (5 of 9 patients) was significantly higher than in the itraconazole group (0 of 7 patients; P = .03). Our results suggest that both drugs were well tolerated in patients with AML or MDS who received chemotherapy and that the efficacy of itraconazole for prophylaxis against systemic fungal disease is not inferior to that of fluconazole.
Ito
Yoshikazu
Y
First Department of Internal Medicine (Hematology Division), Tokyo Medical University, Tokyo, Japan. yito@tokyo-med.ac.jp
Ohyashiki
Kazuma
K
Yoshida
Isao
I
Takeuchi
Makoto
M
Aoyama
Yasutaka
Y
Mugitani
Atsuko
A
Matsuura
Yasuhiro
Y
Wakita
Hisashi
H
Matsuda
Mitsuhiro
M
Sakamoto
Erina
E
Kiguchi
Toru
T
Urabe
Akio
A
Tamura
Kazuo
K
Kanamaru
Akihisa
A
Masaoka
Toru
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002214:Capsules; D005260:Female; D015725:Fluconazole / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage* / Q000009:adverse effects; D007564:Japan; D015470:Leukemia, Myeloid, Acute / Q000150:complications / Q000188:drug therapy; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000209:etiology / Q000517:prevention & control*; D009190:Myelodysplastic Syndromes / Q000097:blood / Q000188:drug therapy
D000935:Antifungal Agents; D002214:Capsules; D017964:Itraconazole; D015725:Fluconazole