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Mortality Due to Invasive Mycoses

Mortality Due to Invasive Mycoses. United States, 1980-1997. McNeil MM, et al. Clin Infect Dis 2001;33:641-7. Invasive Aspergillosis Mortality Review of Literature after 1995. Review of 1941 Patients from 50 Studies. Lin S-J et al, Clin Infect Dis 2001; 32:358-66.

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Mortality Due to Invasive Mycoses

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  1. Mortality Due to Invasive Mycoses United States, 1980-1997 McNeil MM, et al. Clin Infect Dis 2001;33:641-7

  2. Invasive Aspergillosis Mortality Review of Literature after 1995 Review of 1941 Patients from 50 Studies Lin S-J et al, Clin Infect Dis 2001; 32:358-66

  3. IDSA Practice Guidelines for Aspergillus • Early management • Prompt, aggressive diagnosis (BIII) • Therapy initiated on suspicion of diagnosis (BIII) • Antifungal therapy • Intravenous therapy initiated (BIII) • AmB deoxycholate at maximum doses (1-1.5 mg/kg/d) (BIII) • Lipid AmB: impaired renal function or intolerance (AII) • Itraconazole: oral therapy, sequential use (CIII) • Adjunctive therapy: Surgery, combinations, immunotherapy (CIII) • New therapies and diagnostic tools needed to improve prognosis Stevens DA et al, Clin Infect Dis 2000;30:696-709

  4. Invasive Aspergillosis: Disease Spectrum, Treatment Practices, & Outcome Underlying Disease (n) Complete/Partial Responses (%) Overall (595) 37% Severe Immunosuppression (363) 28 Allo BMT (151) 13 Hematological Malignancy (212) 39 Less Severe Immunosuppression (232) 51 Site of Infection Pulmonary (330) 40% Disseminated (without CNS) (114) 18 Central Nervous System (34) 9 Patterson TF, et al. Medicine, 2000;79:250-60

  5. Trial Design for Invasive Mycoses • Limitations in trials for invasive mycoses • Relative infrequency • Difficult diagnosis (surrogate markers, high resolution imaging) • Host factors (underlying conditions, disease presentation) • Trial issues (slow enrollment, expensive, difficult, use of approved comparators, definitions/endpoints) • Large, prospective randomized trials for invasive aspergillosis: 2 • Ellis, 1998 (87 pts): Liposomal AmB 1 vs 4 • Bowden, 1998 (103 pts): ABCD vs D-AmB Rex JH et al, CID 2001;33:95-106; Patterson TF, et al. ICAAC 2000;abstract 1324.

  6. Treatment of Invasive Aspergillosis: Unmet Medical Needs* Hiemenz, 1995 ABLC (n) Control (n) Historical Control 42% (151) 23% (122) Maertens, 2001 Caspofungin Control Historical Control 41% (56) 17% (206) Leenders, 1998 L-AmB D-AmB Open, Randomized 52% (25) 29% (28) Includes suspected infections *Complete & Partial Responses Hiemenz JW, et al. Blood 1995;86(suppl 1):849a; Maertens J, et al. ECCMID 2001;abstract O248; Leenders ACAP et al. Br J Haem 1998;103:205

  7. Efficacy of Empirical L-AmB vs Amphotericin B Deoxycholate in Neutropenic Patients* L-AmB (343) AmB Deoxycholate (344) Aspergillus 12 15 Candida 3 12 Fusarium 1 1 Zygomycetes 1 0 Other 0 2 Total 17 (5.0%) 30 (8.7%) *Proven or probable breakthrough fungal infection Walsh TJ et al, New Eng J Med, 1999;340:764-71

  8. Invasive Mycoses: Present and Future • Epidemiology • Increasing number of patients at risk • Changing patterns of disease • Major cause of morbidity and mortality • Improved prognosis • Prompt diagnosis • Host factors • Antifungal therapy • Early, aggressive “induction” antifungal therapy • New approaches and new agents needed

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