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

David W. Denning, Kieren 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

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)337-349
Number of pages13
JournalJournal of Infection
Volume53
Issue number5
DOIs
StatePublished - Nov 2006
Externally publishedYes

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Aspergillosis
Antifungal Agents
Salvage Therapy
Therapeutics
Aspergillus
Echinocandins
Lipopeptides
micafungin
Hematopoietic Stem Cell Transplantation
Graft vs Host Disease
Hematologic Neoplasms
Candida
Safety
Drug Therapy
Lung

Keywords

  • Amphotericin B
  • Antifungal
  • Aspergillosis
  • Combination
  • Echinocandin
  • Micafungin

ASJC Scopus subject areas

  • Applied Microbiology and Biotechnology
  • Microbiology
  • Parasitology
  • Virology
  • Immunology and Allergy
  • Infectious Diseases

Cite this

Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. / Denning, David W.; Marr, Kieren; Lau, Wendi M.; Facklam, David P.; Ratanatharathorn, Voravit; Becker, Cornelia; Ullmann, Andrew J.; Seibel, Nita L.; Flynn, Patricia M.; van Burik, Jo Anne H; Buell, Donald N.; Patterson, Thomas F.

In: Journal of Infection, Vol. 53, No. 5, 11.2006, p. 337-349.

Research output: Contribution to journalArticle

Denning, DW, Marr, K, Lau, WM, Facklam, DP, Ratanatharathorn, V, Becker, C, Ullmann, AJ, Seibel, NL, Flynn, PM, van Burik, JAH, Buell, DN & Patterson, TF 2006, 'Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis', Journal of Infection, vol. 53, no. 5, pp. 337-349. https://doi.org/10.1016/j.jinf.2006.03.003
Denning, David W. ; Marr, Kieren ; Lau, Wendi M. ; Facklam, David P. ; Ratanatharathorn, Voravit ; Becker, Cornelia ; Ullmann, Andrew J. ; Seibel, Nita L. ; Flynn, Patricia M. ; van Burik, Jo Anne H ; Buell, Donald N. ; Patterson, Thomas F. / Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis. In: Journal of Infection. 2006 ; Vol. 53, No. 5. pp. 337-349.
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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.",
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T1 - Micafungin (FK463), alone or in combination with other systemic antifungal agents, for the treatment of acute invasive aspergillosis

AU - Denning, David W.

AU - Marr, Kieren

AU - Lau, Wendi M.

AU - Facklam, David P.

AU - Ratanatharathorn, Voravit

AU - Becker, Cornelia

AU - Ullmann, Andrew J.

AU - Seibel, Nita L.

AU - Flynn, Patricia M.

AU - van Burik, Jo Anne H

AU - Buell, Donald N.

AU - Patterson, Thomas F.

PY - 2006/11

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N2 - 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.

AB - 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.

KW - Amphotericin B

KW - Antifungal

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KW - Combination

KW - Echinocandin

KW - Micafungin

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