4.5 Article

Efficacy and safety of micafungin for treatment of serious Candida infections in patients with or without malignant disease

Journal

MYCOSES
Volume 54, Issue 6, Pages E838-E847

Publisher

WILEY-BLACKWELL
DOI: 10.1111/j.1439-0507.2011.02045.x

Keywords

Candidaemia; candidiasis; malignancy; mycamine

Funding

  1. Astellas Pharma US
  2. Astellas Pharma Europe Ltd

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The aim of this study was to evaluate micafungin efficacy for treatment of invasive candidiasis /candidaemia in patients with cancer. Modified intent-to-treat populations were analysed from two trials: one, in adults and children with confirmed Candida infection, compared micafungin (adults 100 mg day(-1); children 2 mg kg(-1) day(-1)) with liposomal amphotericin B (L-AmB 3 mg kg(-1) day(-1)); and the other, in adults only, compared micafungin (100 or 150 mg day(-1)) with caspofungin (50 mg day(-1); 70 mg loading dose). Primary efficacy endpoint in both trials was treatment success, defined as both clinical and mycological response at end of therapy. In the micafungin /L-AmB trial, 183 /489 patients had malignancy (37% neutropenic). In the micafungin /caspofungin trial, 176 /572 patients had malignancy (26% neutropenic). Micafungin treatment success rates were generally similar in patients with /without malignancy and to rates observed with L-AmB and caspofungin. Most patients with malignancy and neutropenia were successfully treated by all three drugs. For all drugs, incidence of discontinuations because of treatment-related adverse events was similar for patients with malignancy (<= 7.7%) vs. no malignancy (<= 8.0%). These results suggest that compared with L-AmB and caspofungin, micafungin was effective and well tolerated in patients with candidiasis /candidaemia with /without malignancy. Further prospective trials are recommended to evaluate comparative outcomes with a primary focus on patients with malignancies and invasive candidiasis.

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