Micafungin for empirical antifungal therapy in patients with febrile neutropenia: Multicenter phase 2 study

Hiroki Mizuno, Masashi Sawa, Masamitsu Yanada, Mizuho Shirahata, Masato Watanabe, Tomonori Kato, Hirokazu Nagai, Yukiyasu Ozawa, Takanobu Morishita, Motohiro Tsuzuki, Emi Goto, Akane Tsujimura, Ritsuro Suzuki, Yoshiko Atsuta, Nobuhiko Emi, Tomoki Naoe

Research output: Contribution to journalArticlepeer-review

Abstract

Empirical antifungal therapy is the current standard of care for patients with febrile neutropenia unresponsive to broad-spectrum antimicrobials. Although a number of antifungal agents are currently available, the need remains for effective but less toxic alternatives for this indication. We therefore conducted a phase 2 study of micafungin for 80 patients with hematologic diseases who were suffering from persistent or recurrent fever after at least 96 h of antibacterial therapy. The patients were treated with micafungin at a fixed dose of 150 mg/day. Of the 78 evaluable patients, 54 (69 %) achieved defervescence by the time of neutrophil recovery, and 56 (72 %) completed the treatment in accordance with the provision of the protocol. Four patients developed invasive fungal infection, nine changed antifungal therapy because of lack of efficacy, and three discontinued micafungin because of drug-related adverse events. Based on the composite end point taking account of these, the overall treatment success rate was 60 %, with the lower limit of a 90 % confidence interval (50.3 %) exceeding the predefined threshold success rate (50 %). These findings show the efficacy and safety of micafungin for empirical antifungal therapy in patients with persistent or recurrent febrile neutropenia, warranting further investigation of this drug in a phase 3 study.

Original languageEnglish
Pages (from-to)231-236
Number of pages6
JournalInternational Journal of Hematology
Volume98
Issue number2
DOIs
Publication statusPublished - 08-2013
Externally publishedYes

All Science Journal Classification (ASJC) codes

  • Hematology

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