title: Efficacy and safety of micafungin for prophylaxis of invasive fungal infections in patients undergoing haplo-identical hematopoietic SCT.
abstract: Invasive fungal infections (IFIs) such as candidiasis and mold infections have caused significant morbidity and mortality among immunocompromised patients in recent years. Micafungin, a new echinocandin, inhibits fungal cell wall β-glucan synthesis, with potent activity against most species of Candida and Aspergillus. The aim of this observational study was to investigate the efficacy and safety of micafungin in prophylaxis of IFIs in 26 high-risk adult patients with various hematological diseases receiving haplo-identical Allo-SCT. Only two patients had a history of possible aspergillosis before transplant treated by voriconazole. The patients received a median of four lines (2-7) of treatment before Allo-SCT. Thirteen patients (50%) received at least one prior Auto-SCT; and eight patients (31%) received a previous Allo-SCT. Patients received a median of 29 infusions (range, 15-85) of micafungin (50 mg/day i.v. as a 1-h infusion). The treatment was initiated at the beginning of the transplant conditioning regimen until the hospital discharge. None of our patients discontinued the treatment for drug-related adverse events. Micafungin was not associated with any hepatotoxicity. Only one patient (4%) discontinued the treatment because of early disease progression. In all patients no Candida and/or Aspergillus species was documented after 3 and 6 months from transplant. None of our patients presented a positive galactomannan antigenemia >0.5. Nine patients (35%) presented a CMV reactivation. Four patients presented an acute GVHD grade II and two patients presented a chronic GVHD. The median follow-up was 11 months (3-23). At the last follow-up, there were 20 patients (77%) who were alive; four patients (12%) died because of disease progression and two patients because of graft failure. Micafungin has a good safety and tolerability profile, with an efficacy in preventing IFI in this high-risk population. Our data provide support for an efficacy study in a prophylaxis setting, but prospective and comparative clinical trials using micafungin are urgently needed to define the role of this drug in prophylaxis after haplo-identical Allo-SCT.
authors.affiliation: 1] Unité de Transplantation et de Thérapie Cellulaire (U2T), Institut Paoli-Calmettes, Marseille, France [2] Département d'Onco-Hématologie, Institut Paoli-Calmettes, Marseille, France.
authors.forename: J
authors.initials: J
authors.lastname: El-Cheikh
authors.forename: G
authors.initials: G
authors.lastname: Venton
authors.forename: R
authors.initials: R
authors.lastname: Crocchiolo
authors.forename: S
authors.initials: S
authors.lastname: Fürst
authors.forename: C
authors.initials: C
authors.lastname: Faucher
authors.forename: A
authors.initials: A
authors.lastname: Granata
authors.forename: C
authors.initials: C
authors.lastname: Oudin
authors.forename: D
authors.initials: D
authors.lastname: Coso
authors.forename: R
authors.initials: R
authors.lastname: Bouabdallah
authors.forename: N
authors.initials: N
authors.lastname: Vey
authors.forename: S
authors.initials: S
authors.lastname: Duran
authors.forename: E
authors.initials: E
authors.lastname: Fougereau
authors.forename: P
authors.initials: P
authors.lastname: Berger
authors.forename: C
authors.initials: C
authors.lastname: Chabannon
authors.forename: D
authors.initials: D
authors.lastname: Blaise
mesh_terms: D000328:Adult; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D054714:Echinocandins / Q000009:adverse effects* / Q000627:therapeutic use*; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D055666:Lipopeptides / Q000009:adverse effects* / Q000627:therapeutic use*; D008297:Male; D000077551:Micafungin; D008875:Middle Aged; D009181:Mycoses / Q000209:etiology / Q000517:prevention & control*; D019172:Transplantation Conditioning / Q000009:adverse effects / Q000379:methods; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D054714:Echinocandins; D055666:Lipopeptides; D000077551:Micafungin