Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients: The SEIFEM real-life combo study

A. Candoni, M. Caira, S. Cesaro, A. Busca, M. Giacchino, R. Fanci, M. Delia, A. Nosari, A. Bonini, C. Cattaneo, L. Melillo, C. Caramatti, G. Milone, R. Scime', M. Picardi, R. Fanin, L. Pagano

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

This multicentre observational study evaluated the feasibility, efficacy and toxicity of antifungal combination therapy (combo) as treatment of proven or probable invasive fungal diseases (IFDs) in patients with haematological malignancies. Between January 2005 and January 2010, 84 cases of IFDs (39 proven and 45 probable) treated with combo were collected in 20 Hematological Italian Centres, in patients who underwent chemotherapy or allogeneic haematopoietic stem cell transplantation for haematological diseases. Median age of patients was 34 years (range 1-73) and 37% had less than 18 years. Acute leukaemia was the most common underlying haematological disease (68/84; 81%). The phase of treatment was as follows: first induction in 21/84 (25%), consolidation phase in 18/84 (21%) and reinduction/salvage in 45/84 (54%). The main site of infection was lung with or without other sites. The principal fungal pathogens were as follows: Aspergillus sp. 68 cases (81%), Candida sp. six cases (8%), Zygomycetes four cases (5%) and Fusarium sp. four cases (5%). The most used combo was caspofungin+voriconazole 35/84 (42%), caspofungin + liposomal amphotericin B (L-AmB) 20/84 (24%) and L-AmB+voriconazole 15/84 (18%). The median duration of combo was 19 days (range 3-180). The overall response rate (ORR) was 73% (61/84 responders) without significant differences between the combo regimens. The most important factor that significantly influenced the response was granulocyte (PMN) recovery (P 0.009). Only one patient discontinued therapy (voriconazole-related neurotoxicity) and 22% experienced mild and reversible adverse events (hypokalaemia, ALT/AST increase and creatinine increase). The IFDs-attributable mortality was 17%. This study indicates that combo was both well tolerated and effective in haematological patients. The most used combo regimens were caspofungin + voriconazole (ORR 80%) and caspofungin + L-AmB (ORR 70%). The ORR was 73% and the mortality IFD related was 17%. PMN recovery during combo predicts a favourable outcome. Clinical Trials Registration: NCT00906633.

Original languageEnglish
Pages (from-to)342-350
Number of pages9
JournalMycoses
Volume57
Issue number6
DOIs
Publication statusPublished - 2014

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Mycoses
Multicenter Studies
caspofungin
Safety
Therapeutics
Hematologic Diseases
Hypokalemia
Mortality
Hematopoietic Stem Cell Transplantation
Fusarium
Hematologic Neoplasms
Aspergillus
Candida
Granulocytes
Observational Studies
Creatinine
Leukemia
Clinical Trials
Drug Therapy

Keywords

  • Amphothericin
  • Caspofungin
  • Combined antifungal therapy
  • Invasive fungal disease
  • Posaconazole
  • Voriconazole

ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases
  • Medicine(all)

Cite this

Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients : The SEIFEM real-life combo study. / Candoni, A.; Caira, M.; Cesaro, S.; Busca, A.; Giacchino, M.; Fanci, R.; Delia, M.; Nosari, A.; Bonini, A.; Cattaneo, C.; Melillo, L.; Caramatti, C.; Milone, G.; Scime', R.; Picardi, M.; Fanin, R.; Pagano, L.

In: Mycoses, Vol. 57, No. 6, 2014, p. 342-350.

Research output: Contribution to journalArticle

Candoni, A, Caira, M, Cesaro, S, Busca, A, Giacchino, M, Fanci, R, Delia, M, Nosari, A, Bonini, A, Cattaneo, C, Melillo, L, Caramatti, C, Milone, G, Scime', R, Picardi, M, Fanin, R & Pagano, L 2014, 'Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients: The SEIFEM real-life combo study', Mycoses, vol. 57, no. 6, pp. 342-350. https://doi.org/10.1111/myc.12161
Candoni, A. ; Caira, M. ; Cesaro, S. ; Busca, A. ; Giacchino, M. ; Fanci, R. ; Delia, M. ; Nosari, A. ; Bonini, A. ; Cattaneo, C. ; Melillo, L. ; Caramatti, C. ; Milone, G. ; Scime', R. ; Picardi, M. ; Fanin, R. ; Pagano, L. / Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients : The SEIFEM real-life combo study. In: Mycoses. 2014 ; Vol. 57, No. 6. pp. 342-350.
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abstract = "This multicentre observational study evaluated the feasibility, efficacy and toxicity of antifungal combination therapy (combo) as treatment of proven or probable invasive fungal diseases (IFDs) in patients with haematological malignancies. Between January 2005 and January 2010, 84 cases of IFDs (39 proven and 45 probable) treated with combo were collected in 20 Hematological Italian Centres, in patients who underwent chemotherapy or allogeneic haematopoietic stem cell transplantation for haematological diseases. Median age of patients was 34 years (range 1-73) and 37{\%} had less than 18 years. Acute leukaemia was the most common underlying haematological disease (68/84; 81{\%}). The phase of treatment was as follows: first induction in 21/84 (25{\%}), consolidation phase in 18/84 (21{\%}) and reinduction/salvage in 45/84 (54{\%}). The main site of infection was lung with or without other sites. The principal fungal pathogens were as follows: Aspergillus sp. 68 cases (81{\%}), Candida sp. six cases (8{\%}), Zygomycetes four cases (5{\%}) and Fusarium sp. four cases (5{\%}). The most used combo was caspofungin+voriconazole 35/84 (42{\%}), caspofungin + liposomal amphotericin B (L-AmB) 20/84 (24{\%}) and L-AmB+voriconazole 15/84 (18{\%}). The median duration of combo was 19 days (range 3-180). The overall response rate (ORR) was 73{\%} (61/84 responders) without significant differences between the combo regimens. The most important factor that significantly influenced the response was granulocyte (PMN) recovery (P 0.009). Only one patient discontinued therapy (voriconazole-related neurotoxicity) and 22{\%} experienced mild and reversible adverse events (hypokalaemia, ALT/AST increase and creatinine increase). The IFDs-attributable mortality was 17{\%}. This study indicates that combo was both well tolerated and effective in haematological patients. The most used combo regimens were caspofungin + voriconazole (ORR 80{\%}) and caspofungin + L-AmB (ORR 70{\%}). The ORR was 73{\%} and the mortality IFD related was 17{\%}. PMN recovery during combo predicts a favourable outcome. Clinical Trials Registration: NCT00906633.",
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T1 - Multicentre surveillance study on feasibility, safety and efficacy of antifungal combination therapy for proven or probable invasive fungal diseases in haematological patients

T2 - The SEIFEM real-life combo study

AU - Candoni, A.

AU - Caira, M.

AU - Cesaro, S.

AU - Busca, A.

AU - Giacchino, M.

AU - Fanci, R.

AU - Delia, M.

AU - Nosari, A.

AU - Bonini, A.

AU - Cattaneo, C.

AU - Melillo, L.

AU - Caramatti, C.

AU - Milone, G.

AU - Scime', R.

AU - Picardi, M.

AU - Fanin, R.

AU - Pagano, L.

PY - 2014

Y1 - 2014

N2 - This multicentre observational study evaluated the feasibility, efficacy and toxicity of antifungal combination therapy (combo) as treatment of proven or probable invasive fungal diseases (IFDs) in patients with haematological malignancies. Between January 2005 and January 2010, 84 cases of IFDs (39 proven and 45 probable) treated with combo were collected in 20 Hematological Italian Centres, in patients who underwent chemotherapy or allogeneic haematopoietic stem cell transplantation for haematological diseases. Median age of patients was 34 years (range 1-73) and 37% had less than 18 years. Acute leukaemia was the most common underlying haematological disease (68/84; 81%). The phase of treatment was as follows: first induction in 21/84 (25%), consolidation phase in 18/84 (21%) and reinduction/salvage in 45/84 (54%). The main site of infection was lung with or without other sites. The principal fungal pathogens were as follows: Aspergillus sp. 68 cases (81%), Candida sp. six cases (8%), Zygomycetes four cases (5%) and Fusarium sp. four cases (5%). The most used combo was caspofungin+voriconazole 35/84 (42%), caspofungin + liposomal amphotericin B (L-AmB) 20/84 (24%) and L-AmB+voriconazole 15/84 (18%). The median duration of combo was 19 days (range 3-180). The overall response rate (ORR) was 73% (61/84 responders) without significant differences between the combo regimens. The most important factor that significantly influenced the response was granulocyte (PMN) recovery (P 0.009). Only one patient discontinued therapy (voriconazole-related neurotoxicity) and 22% experienced mild and reversible adverse events (hypokalaemia, ALT/AST increase and creatinine increase). The IFDs-attributable mortality was 17%. This study indicates that combo was both well tolerated and effective in haematological patients. The most used combo regimens were caspofungin + voriconazole (ORR 80%) and caspofungin + L-AmB (ORR 70%). The ORR was 73% and the mortality IFD related was 17%. PMN recovery during combo predicts a favourable outcome. Clinical Trials Registration: NCT00906633.

AB - This multicentre observational study evaluated the feasibility, efficacy and toxicity of antifungal combination therapy (combo) as treatment of proven or probable invasive fungal diseases (IFDs) in patients with haematological malignancies. Between January 2005 and January 2010, 84 cases of IFDs (39 proven and 45 probable) treated with combo were collected in 20 Hematological Italian Centres, in patients who underwent chemotherapy or allogeneic haematopoietic stem cell transplantation for haematological diseases. Median age of patients was 34 years (range 1-73) and 37% had less than 18 years. Acute leukaemia was the most common underlying haematological disease (68/84; 81%). The phase of treatment was as follows: first induction in 21/84 (25%), consolidation phase in 18/84 (21%) and reinduction/salvage in 45/84 (54%). The main site of infection was lung with or without other sites. The principal fungal pathogens were as follows: Aspergillus sp. 68 cases (81%), Candida sp. six cases (8%), Zygomycetes four cases (5%) and Fusarium sp. four cases (5%). The most used combo was caspofungin+voriconazole 35/84 (42%), caspofungin + liposomal amphotericin B (L-AmB) 20/84 (24%) and L-AmB+voriconazole 15/84 (18%). The median duration of combo was 19 days (range 3-180). The overall response rate (ORR) was 73% (61/84 responders) without significant differences between the combo regimens. The most important factor that significantly influenced the response was granulocyte (PMN) recovery (P 0.009). Only one patient discontinued therapy (voriconazole-related neurotoxicity) and 22% experienced mild and reversible adverse events (hypokalaemia, ALT/AST increase and creatinine increase). The IFDs-attributable mortality was 17%. This study indicates that combo was both well tolerated and effective in haematological patients. The most used combo regimens were caspofungin + voriconazole (ORR 80%) and caspofungin + L-AmB (ORR 70%). The ORR was 73% and the mortality IFD related was 17%. PMN recovery during combo predicts a favourable outcome. Clinical Trials Registration: NCT00906633.

KW - Amphothericin

KW - Caspofungin

KW - Combined antifungal therapy

KW - Invasive fungal disease

KW - Posaconazole

KW - Voriconazole

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U2 - 10.1111/myc.12161

DO - 10.1111/myc.12161

M3 - Article

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JO - Mycoses

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