Empirical voriconazole therapy for febrile neutropenic patients with hematological disorders: A prospective multicenter trial in Japan

Hideo Koh, Masayuki Hino, Kensuke Ohta, Masaki Iino, Fumiaki Urase, Masaki Yamaguchi, Jun Yamanouchi, Noriko Usui, Minoru Yoshida, Mitsune Tanimoto, Kazuma Ohyashiki, Akio Urabe, Kazuo Tamura, Akihisa Kanamaru, Tohru Masaoka

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Abstract

An open-label, prospective, multicenter study was conducted between October 2006 and March 2010 to assess the efficacy and safety of intravenous voriconazole (VRCZ) as empirical therapy for antibiotic-refractory febrile neutropenia in Japanese patients with hematological disorders. In addition, to find the patient groups that may benefit from antifungal therapy, the definition of invasive fungal infection proposed by EORTC/MSG (2002) was assessed in this study. Plasma (1-3)-β-d-glucan and Aspergillus PCR in blood were also measured to improve the diagnostic accuracy. A total of 103 patients (median age, 59 years), including 25 undergoing induction chemotherapies and 19 allogeneic hematopoietic cell transplants, were evaluable. Sixty-nine percent of the patients achieved resolution of clinical symptoms and 31 % achieved treatment success, defined as fulfilling the previously described five-part composite endpoint. Although VRCZ was discontinued in 9.7 % of the patients because of adverse effects, all the patients recovered soon after discontinuation of VRCZ. The treatment success rate of VRCZ appeared to be higher in patients categorized as "not classified" compared with "possible invasive fungal disease" according to the EORTC/MSG criteria. Moreover, six "not classified" patients were positive for either plasma (1-3)-β-d-glucan (n = 5) or Aspergillus PCR in blood (n = 2). The present study demonstrates that empirical VRCZ therapy is safe and effective in Japanese patients. Additionally, (1-3)-β-d-glucan and Aspergillus PCR tests were expected to provide additional information on the diagnosis of invasive fungal infections.

Original languageEnglish
Pages (from-to)1126-1134
Number of pages9
JournalJournal of Infection and Chemotherapy
Volume19
Issue number6
DOIs
Publication statusPublished - Dec 2013
Externally publishedYes

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Keywords

  • Empirical antifungal therapy
  • Prospective multicenter study
  • Voriconazole

ASJC Scopus subject areas

  • Microbiology (medical)
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

Koh, H., Hino, M., Ohta, K., Iino, M., Urase, F., Yamaguchi, M., Yamanouchi, J., Usui, N., Yoshida, M., Tanimoto, M., Ohyashiki, K., Urabe, A., Tamura, K., Kanamaru, A., & Masaoka, T. (2013). Empirical voriconazole therapy for febrile neutropenic patients with hematological disorders: A prospective multicenter trial in Japan. Journal of Infection and Chemotherapy, 19(6), 1126-1134. https://doi.org/10.1007/s10156-013-0634-5