title: Efficacy and safety of micafungin for treatment of serious Candida infections in patients with or without malignant disease.
abstract: 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.
authors.affiliation: Klinik I für Innere Medizin der Universität zu Köln, and Zentrum für Klinische Studien (BMBF 01KN0706), Köln, Germany. oliver.cornely@zks-koeln.de
authors.forename: Oliver A
authors.initials: OA
authors.lastname: Cornely
authors.forename: Francisco M
authors.initials: FM
authors.lastname: Marty
authors.forename: Flavie
authors.initials: F
authors.lastname: Stucker
authors.forename: Peter G
authors.initials: PG
authors.lastname: Pappas
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Ullmann
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000666:Amphotericin B / Q000008:administration & dosage / Q000009:adverse effects; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D002177:Candidiasis / Q000188:drug therapy*; D000077336:Caspofungin; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D054714:Echinocandins / Q000008:administration & dosage* / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D055666:Lipopeptides / Q000008:administration & dosage* / Q000009:adverse effects*; D008297:Male; D000077551:Micafungin; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D054714:Echinocandins; D055666:Lipopeptides; C068538:liposomal amphotericin B; D000666:Amphotericin B; D000077336:Caspofungin; D000077551:Micafungin