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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

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Abstract

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 * 109/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.

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Authors and Affiliations

  1. First Department of Internal Medicine (Hematology Division), Tokyo Medical University, 6-7-1-Nishishinjuku, 160-0023, Shinjuku-ku, Tokyo, Japan

    Kazuma Ohyashiki & Isao Yoshida

  2. Department of Internal Medicine, National Hospital Organization Minami-Okayama Medical Center, Okayama, Japan

    Makoto Takeuchi & Yasutaka Aoyama

  3. Department of Hematology, Fuchu Hospital, Izumi, Japan

    Atsuko Mugitani

  4. Department of Internal Medicine, Narita Red Cross Hospital, Narita, Japan

    Yasuhiro Matsuura & Hisashi Wakita

  5. Department of Hematology, Kinki University School of Medicine, Osaka-Sayama, Japan

    Mitsuhiro Matsuda & Akihisa Kanamaru

  6. Department of Clinical Hematology and Clinical Diagnostics, Graduate School of Medicine, Osaka City University, Osaka, Japan

    Erina Sakamoto

  7. Department of Internal Medicine, Kagawa Rosai Hospital, Marugame, Japan

    Toru Kiguchi

  8. Division of Hematology, NTT Kanto Medical Center, Tokyo, Japan

    Akio Urabe

  9. First Department of Internal Medicine, School of Medicine, Fukuoka University, Fukuoka, Japan

    Kazuo Tamura

  10. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan

    Toru Masaoka

Authors
  1. Yoshikazu Ito
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  2. Kazuma Ohyashiki
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  15. Toru Masaoka
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The Japan Febrile Neutropenia Study Group

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Ito, Y., Ohyashiki, K., Yoshida, I. et al. 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. Int J Hematol 85, 121–127 (2007). https://doi.org/10.1532/IJH97.06079

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  • DOI: https://doi.org/10.1532/IJH97.06079

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