Invasive fungal infections (IFI) such as candidiasis and mold infections cause significant morbidity and mortality among immunocompromised patients in recent years. Micafungin, a new echinocandin, inhibits fungal cell wall beta-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 invasive fungal infections (IFI) in high risk adult patients with various haematological diseases receiving haplo-identical allogeneic stem cell transplantation (Allo-SCT).
26 patients were identified. Only 2 patients had a history of possible aspergillosis before transplant treated by voriconazole. The patients received a median of 4 lines (2-7) of chemotherapies before Allo-SCT. Thirteen patients (50%) received at least one prior auto-SCT; and 8 patients (31%) received a previous Allo-SCT. 24 patients (92%) received a reduced intensity conditioning regimen (RIC), with Fludarabine, Cyclophosphamide and Total body irradiation (TBI) 2 Gy based (80%), or Fludarabine, Busulfan, and Cyclophosphamide based (8%) or other (4%). while two patients (8%) received a myeloablative conditioning regimen with thiotepa.
The treatment was initiated at the beginning of the transplant conditioning regimen until the hospital discharge. Patients received a median of 29 infusions (range, 15–85) of Micafungin (50 mg/day i.v. as a 1h infusion).
Results: 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 an early disease progression.
At last follow-up, there are 21 patients (81%) who are alive, with a median follow-up of 10 months (3-22). three patients (12%) dead because disease progression and two patients because graft failure.
In all patients no candidas and/or Aspergillus species was documented after 3 and 6 months from transplant. None of our patients presented a positive galactomannan antigenemia >0.5.Four patients presented an acute GvHD grade II and 2 patients presented a chronic GvHD.
Conclusion: 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.
Full conference title:
- EBMT 39th (2013)