Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis.

Abstract

BACKGROUND:

Micafungin (FK463) is a new lipopeptide compound (echinocandin) with activity against Aspergillus and Candida species. This study evaluated the safety and efficacy of micafungin in patients with proven or probable invasive aspergillosis (IA).

METHODS:

A multinational, non-comparative study was conducted to examine proven or probable (pulmonary only) Aspergillus species infection in a wide variety of patient populations. The study employed an open-label design utilizing micafungin alone or in combination with another systemic antifungal agent. Criteria for IA and therapeutic responses were judged by an independent panel.

RESULTS:

Of the 331 patients enrolled, only 225 met diagnostic criteria for IA as determined by the independent panel and received at least one dose of micafungin. Patients included 98/225 who had undergone hematopoietic stem cell transplantation (HSCT) (88/98 allogeneic), 48 with graft versus host disease (GVHD), and 83/225 who had received chemotherapy for hematologic malignancy. A favorable response rate at the end of therapy was seen in 35.6% (80/225) of patients. Of those only treated with micafungin, favorable responses were seen in 6/12 (50%) of the primary and 9/22 (40.9%) of the salvage therapy group, with corresponding numbers in the combination treatment groups of 5/17 (29.4%) and 60/174 (34.5%) of the primary and salvage treatment groups, respectively. Of the 326 micafungin-treated patients, 183 (56.1%) died during therapy or in the 6-week follow-up phase; 107 (58.5%) deaths were attributable to IA.

CONCLUSIONS:

Micafungin as primary or salvage therapy proved efficacious and safe in high-risk patients with IA, although patient numbers are small in the micafungin-only groups.

• Authors: David W Denning, Kieren A Marr, Wendi M Lau, David P Facklam, Voravit Ratanatharathorn, Cornelia Becker, Andrew J Ullmann, Nita L Seibel, Patricia M Flynn, Jo-Anne H van Burik, Donald N Buell, Thomas F Patterson
• Journal: The Journal of infection (J Infect) Vol. 53 Issue 5 Pg. 337-49 (Nov 2006) ISSN: 1532-2742 [Electronic] England
• PMID: 16678903 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antifungal Agents
• Echinocandins
• Lipopeptides
• Lipoproteins
• Peptides, Cyclic
• Micafungin

Topics

• Acute Disease
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antifungal Agents (administration & dosage, therapeutic use)
• Aspergillosis (drug therapy)
• Child
• Child, Preschool
• Drug Therapy, Combination
• Echinocandins
• Female
• Humans
• Infant
• Lipopeptides
• Lipoproteins (administration & dosage, therapeutic use)
• Male
• Micafungin
• Middle Aged
• Peptides, Cyclic (administration & dosage, therapeutic use)